U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q/A

(Amendment No. 1)












| | x | QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
| | - | ---------------------------------------------------------------------------------------



For the quarterly period ended    September
30, 2015



or



| |  ̈ | TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIESEXCHANGE ACT OF 1934
| | - | ---------------------------------------------------------------------------------------



For the transition period ended                                            to



|Commission File Number: 001-15697                     
|------------------------------------------------------
|                                                      
|ELITE PHARMACEUTICALS, INC.                           
|(Exact name of registrant as specified in its charter)



|Nevada                                                         |  | 22-3542636                          
|-------------------------------------------------------------- |  | ------------------------------------
|(State or other jurisdiction of incorporation or organization) |  | (I.R.S. Employer Identification No.)
|                                                               |  |                                     
|165 Ludlow Avenue, Northvale, New Jersey                       |  | 07647                               
|(Address of principal executive offices)                       |  | (Zip Code)                          



|(201) 750-2646                                      
|----------------------------------------------------
|(Registrant's telephone number, including area code)



(Former name,
former address and former fiscal year, if changed since last report)



Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.



YesxNo ̈



Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post
such files).



YesxNo ̈



Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and
large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):



|Large Accelerated filer ̈ | Accelerated Filerx | Non-Accelerated Filer ̈ | Smaller Reporting Company ̈
|------------------------ | ------------------ | ---------------------- | --------------------------



Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act).

Yes ̈Nox





Indicate the number of shares outstanding
of each of the issuer’s classes of common stock, as of the latest practicable date. As of November 5, 2015, the issuer had
outstanding 684,756,279 shares of common stock, $0.001 par value (exclusive of 100,000 shares held in treasury).













EXPLANATORY NOTE



This amended Form 10-Q for the quarter ended September 30, 2015
(“Form 10-Q/A”) only amends information in Part I, Item 1 of the original Form 10-Q, previously filed with the Commission
on November 9, 2015 (the “Original Filing”).



Specifically, the headings in certain columns in the Statements
of Cash Flows were inadvertently switched in the Original Filing. This Form 10-Q/A corrects the column headings.



All other information and items as presented
in the Original Filing are unchanged. Except for the foregoing amended and restated information, this Amendment does not amend,
update or change any other information presented in the Original Filing.



In addition, as required by Rule 12b-15 of the Securities Exchange Act of 1934, this Form 10-Q/A contains
new certifications by our principal executive officer and our principal financial and accounting officer, filed as exhibits hereto.













ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY



INDEX



|           |                                                                                                                                             |    | Page No.
|---------- | ------------------------------------------------------------------------------------------------------------------------------------------- | -- | --------
|           | PART I – FINANCIAL INFORMATION                                                                                                              |    |         
|           |                                                                                                                                             |    |         
|Item 1.    | Financial Statements                                                                                                                        |    |         
|           |                                                                                                                                             |    |         
|           | Condensed Consolidated Balance Sheets as of September 30, 2015 (unaudited) and March 31, 2015 (audited)                                     |    | F-1     
|           |                                                                                                                                             |    |         
|           | Condensed Consolidated Statements of Operations for the six months ended September 30, 2015  (unaudited) and September 30, 2014 (unaudited) |    | F-3     
|           |                                                                                                                                             |    |         
|           | Condensed Consolidated Statement of Changes in Stockholders’ Deficit for the six months ended September 30, 2015 (unaudited)                |    | F-4     
|           |                                                                                                                                             |    |         
|           | Condensed Consolidated Statements of Cash Flows for the six months ended September 30, 2015 (unaudited) and September 30, 2014 (unaudited)  |    | F-5     
|           |                                                                                                                                             |    |         
|           | Notes to Condensed Consolidated Financial Statements                                                                                        |    | F-6     
|           |                                                                                                                                             |    |         
|Item 2.    | Management’s Discussion and Analysis of Financial Condition and Results of Operations                                                       |    | 1       
|           |                                                                                                                                             |    |         
|Item 3.    | Quantitative and Qualitative Disclosures about Market Risk                                                                                  |    | 16      
|           |                                                                                                                                             |    |         
|Item 4.    | Controls and Procedures                                                                                                                     |    | 17      
|           |                                                                                                                                             |    |         
|           | PART II – OTHER INFORMATION                                                                                                                 |    |         
|           |                                                                                                                                             |    |         
|Item 1.    | Legal Proceedings                                                                                                                           |    | 17      
|           |                                                                                                                                             |    |         
|Item 1A.   | Risk Factors                                                                                                                                |    | 18      
|           |                                                                                                                                             |    |         
|Item 2.    | Unregistered Sales of Equity Securities and Use of Proceeds                                                                                 |    | 18      
|           |                                                                                                                                             |    |         
|Item 3.    | Defaults upon Senior Securities                                                                                                             |    | 18      
|           |                                                                                                                                             |    |         
|Item 4.    | Mine Safety Disclosures                                                                                                                     |    | 18      
|           |                                                                                                                                             |    |         
|Item 5.    | Other Information                                                                                                                           |    | 18      
|           |                                                                                                                                             |    |         
|Item 6.    | Exhibits                                                                                                                                    |    | 18      
|           |                                                                                                                                             |    |         
|SIGNATURES |                                                                                                                                             | 30











ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY



CONDENSED CONSOLIDATED BALANCE SHEETS





|                                                                                                   |  | September 30, 2015 (Unaudited) |            |  | March 31, 2015 (Audited) |  
|-------------------------------------------------------------------------------------------------- |  | ------------------------------ | ---------- |  | ------------------------ | -
|ASSETS                                                                                             |  |                                |            |  |                          |  
|CURRENT ASSETS                                                                                     |  |                                |            |  |                          |  
|Cash                                                                                               |  | $                              | 9,031,088  |  |                          | $
|Accounts receivable (net of allowance for doubtful accounts of $0 and $272,620, respectively)      |  |                                | 1,415,886  |  |                          |  
|Inventories                                                                                        |  |                                | 3,353,313  |  |                          |  
|Prepaid expenses and other current assets                                                          |  |                                | 295,108    |  |                          |  
|                                                                                                   |  |                                |            |  |                          |  
|Total Current Assets                                                                               |  |                                | 14,095,395 |  |                          |  
|                                                                                                   |  |                                |            |  |                          |  
|PROPERTY AND EQUIPMENT, net of accumulated depreciation of $6,392,827 and $6,074,117, respectively |  |                                | 7,554,519  |  |                          |  
|                                                                                                   |  |                                |            |  |                          |  
|INTANGIBLE ASSETS – net of accumulated amortization of $-0-                                        |  |                                | 6,399,667  |  |                          |  
|                                                                                                   |  |                                |            |  |                          |  
|OTHER ASSETS                                                                                       |  |                                |            |  |                          |  
|Security deposits                                                                                  |  |                                | 48,714     |  |                          |  
|Restricted cash – debt service for EDA bonds                                                       |  |                                | 388,959    |  |                          |  
|EDA bond offering costs, net of accumulated amortization of $142,963 and $135,874, respectively    |  |                                | 211,490    |  |                          |  
|                                                                                                   |  |                                |            |  |                          |  
|Total Other Assets                                                                                 |  |                                | 649,163    |  |                          |  
|                                                                                                   |  |                                |            |  |                          |  
|TOTAL ASSETS                                                                                       |  | $                              | 28,698,744 |  |                          | $



The accompanying notes are an integral
part of the condensed consolidated financial statements



F-1







ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY



CONDENSED CONSOLIDATED BALANCE SHEETS





|                                                                                                                                                                                                                                         |  | September 30, 2015 (Unaudited) |              |   | March 31, 2015 (Audited) |  
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |  | ------------------------------ | ------------ | - | ------------------------ | -
|LIABILITIES AND STOCKHOLDERS’ DEFICIT                                                                                                                                                                                                    |  |                                |              |   |                          |  
|CURRENT LIABILITIES                                                                                                                                                                                                                      |  |                                |              |   |                          |  
|Current portion of EDA bonds payable                                                                                                                                                                                                     |  | $                              | 220,000      |   |                          | $
|Short term loans and current portion of long-term debt                                                                                                                                                                                   |  |                                | 251,835      |   |                          |  
|Related Party Line of Credit                                                                                                                                                                                                             |  |                                | 411,709      |   |                          |  
|Accounts payable and accrued expenses                                                                                                                                                                                                    |  |                                | 3,611,073    |   |                          |  
|Deferred revenues                                                                                                                                                                                                                        |  |                                | 13,333       |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|Total Current Liabilities                                                                                                                                                                                                                |  |                                | 4,507,950    |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|LONG TERM LIABILITIES                                                                                                                                                                                                                    |  |                                |              |   |                          |  
|EDA bonds payable – non current                                                                                                                                                                                                          |  |                                | 1,845,000    |   |                          |  
|Deferred revenues                                                                                                                                                                                                                        |  |                                | 118,890      |   |                          |  
|Other long term liabilities                                                                                                                                                                                                              |  |                                | 549,486      |   |                          |  
|Derivative liabilities                                                                                                                                                                                                                   |  |                                | 9,184,216    |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|Total Long Term Liabilities                                                                                                                                                                                                              |  |                                | 11,697,592   |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|TOTAL LIABILITIES                                                                                                                                                                                                                        |  |                                | 16,205,542   |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|MEZZANINE EQUITY                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|Convertible preferred shares                                                                                                                                                                                                             |  |                                | 32,857,143   |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|STOCKHOLDERS’ DEFICIT                                                                                                                                                                                                                    |  |                                |              |   |                          |  
|Common stock – par value $0.001, Authorized 995,000,000 shares and 690,000,000 shares, respectively. Issued 681,756,279 shares and 631,160,701 shares, respectively. Outstanding 680,756,279 shares and 630,060,701 shares, respectively |  |                                | 681,759      |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|Additional paid-in-capital                                                                                                                                                                                                               |  |                                | 116,204,254  |   |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|Accumulated deficit                                                                                                                                                                                                                      |  |                                | (136,943,114 | ) |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|Treasury stock at cost (100,000 common shares)                                                                                                                                                                                           |  |                                | (306,841     | ) |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|TOTAL STOCKHOLDERS’ DEFICIT                                                                                                                                                                                                              |  |                                | (20,363,941  | ) |                          |  
|                                                                                                                                                                                                                                         |  |                                |              |   |                          |  
|TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT                                                                                                                                                                            |  | $                              | 28,698,744   |   |                          | $



The accompanying notes are an integral
part of the condensed consolidated financial statements



F-2







ELITE PHARMACEUTI CALS, INC. AND SUBSIDIARY



CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS

(Unaudited)



|                                                                |  | THREE MONTHS ENDEDSeptember 30, |             |   | SIX MONTHS ENDEDSeptember 30, |  
|--------------------------------------------------------------- |  | ------------------------------- | ----------- | - | ----------------------------- | -
|                                                                |  | 2015                            |             |   | 2014                          |  
|REVENUES                                                        |  |                                 |             |   |                               |  
|Manufacturing Fees                                              |  | $                               | 2,553,195   |   |                               | $
|Licensing Fees                                                  |  |                                 | 143,312     |   |                               |  
|Product Development Licensing                                   |  |                                 | ---         |   |                               |  
|Lab Fee Revenues                                                |  |                                 | ---         |   |                               |  
|                                                                |  |                                 |             |   |                               |  
|Total Revenues                                                  |  |                                 | 2,696,507   |   |                               |  
|                                                                |  |                                 |             |   |                               |  
|COSTS OF REVENUES                                               |  |                                 | 1,414,529   |   |                               |  
|                                                                |  |                                 |             |   |                               |  
|Gross Profit                                                    |  |                                 | 1,281,978   |   |                               |  
|OPERATING EXPENSES                                              |  |                                 |             |   |                               |  
|Research and Development                                        |  |                                 | 4,172,419   |   |                               |  
|General and Administrative                                      |  |                                 | 881,566     |   |                               |  
|Non-cash compensation through issuance of stock options         |  |                                 | 80,992      |   |                               |  
|Depreciation and Amortization                                   |  |                                 | 164,340     |   |                               |  
|Total Operating Expenses                                        |  |                                 | 5,299,317   |   |                               |  
|                                                                |  |                                 |             |   |                               |  
|(LOSS) FROM OPERATIONS                                          |  |                                 | (4,017,339  | ) |                               |  
|                                                                |  |                                 |             |   |                               |  
|OTHER INCOME / (EXPENSES)                                       |  |                                 |             |   |                               |  
|Interest expense                                                |  |                                 | (63,824     | ) |                               |  
|Change in fair value of derivative liabilities                  |  |                                 | 2,149,787   |   |                               |  
|Gain on Sale on Investment                                      |  |                                 | ---         |   |                               |  
|Other Income (Expense)                                          |  |                                 | ---         |   |                               |  
|                                                                |  |                                 |             |   |                               |  
|Total Other Income / (Expense)                                  |  |                                 | 2,085,963   |   |                               |  
|NET INCOME (LOSS)                                               |  | $                               | (1,931,376  | ) |                               | $
|                                                                |  |                                 |             |   |                               |  
|Change in value of convertible preferred share mezzanine equity |  |                                 | (5,071,406  | ) |                               |  
|                                                                |  |                                 |             |   |                               |  
|NET INCOME (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS           |  | $                               | (7,002,782  | ) |                               | $
|NET INCOME (LOSS) PER SHARE                                     |  |                                 |             |   |                               |  
|Basic                                                           |  | $                               | (0.01       | ) |                               | $
|Diluted                                                         |  | $                               | (0.00       | ) |                               | $
|                                                                |  |                                 |             |   |                               |  
|WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING            |  |                                 |             |   |                               |  
|Basic                                                           |  |                                 | 665,330,431 |   |                               |  
|Diluted                                                         |  |                                 | 823,495,279 |   |                               |  



The accompanying notes are an integral
part of the condensed consolidated financial statements



F-3







ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY



CONDENSED CONSOLIDATED STATEMENT OF
CHANGES IN STOCKHOLDERS’ DEFICIT

(Unaudited)





|                                                                                                  |  | COMMON STOCK |             |  |        |   |         | TREASURY STOCK             |  |   |             |   |  |        |        
|------------------------------------------------------------------------------------------------- |  | ------------ | ----------- |  | ------ | - | ------- | -------------------------- |  | - | ----------- | - |  | ------ | -------
|                                                                                                  |  | Shares       |             |  | Amount |   |         | Additional Paid-In Capital |  |   | Shares      |   |  | Amount |        
|Balance at March 31, 2015                                                                         |  |              | 631,160,701 |  |        | $ | 631,162 |                            |  | $ | 108,819,628 |   |  |        | 100,000
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Net Income                                                                                        |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Change in value of convertible preferred mezzanine equity                                         |  |              |             |  |        |   |         |                            |  |   | 2,142,857   |   |  |        |        
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Common shares sold pursuant to the Lincoln Park Capital purchase agreement                        |  |              | 13,155,283  |  |        |   | 13,157  |                            |  |   | 2,766,985   |   |  |        |        
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Non-cash compensation through the issuance of stock options                                       |  |              |             |  |        |   |         |                            |  |   | 171,470     |   |  |        |        
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Common shares issued as commitment shares pursuant to the Lincoln Park Capital purchase agreement |  |              | 134,047     |  |        |   | 134     |                            |  |   | (134        | ) |  |        |        
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Common shares issued pursuant to the exercise of cash warrants                                    |  |              | 37,252,079  |  |        |   | 37,252  |                            |  |   | 2,291,003   |   |  |        |        
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Common Shares Issued Pursuant to Director Salaries                                                |  |              | 54,169      |  |        |   | 54      |                            |  |   | 12,446      |   |  |        |        
|                                                                                                  |  |              |             |  |        |   |         |                            |  |   |             |   |  |        |        
|Balance at September 30, 2015                                                                     |  |              | 681,756,279 |  |        | $ | 681,759 |                            |  | $ | 116,204,255 |   |  |        | 100,000



The accompanying notes are an integral
part of the condensed consolidated financial statements



F-4







ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY



CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS

(Unaudited)



|                                                                           |  | SIX MONTHS ENDED 
SEPTEMBER 30 |           
|-------------------------------------------------------------------------- |  | ------------------------------ | ----------
|                                                                           |  | 2015                           |           
|CASH FLOWS FROM OPERATING ACTIVITIES                                       |  |                                |           
|Net Income (Loss)                                                          |  | $                              | 6,931,921 
|Adjustments to reconcile net loss to cash used in operating activities:    |  |                                |           
|Depreciation and amortization                                              |  |                                | 325,799   
|Change in fair value of derivative liabilities                             |  |                                | (8,578,358
|Non-cash compensation accrued                                              |  |                                | 586,167   
|Non-cash compensation from the issuance of common stock and options        |  |                                | 171,470   
|Non-cash rent expense                                                      |  |                                | (10,991   
|Non-cash lease accretion                                                   |  |                                | 798       
|Gain on Sale of Investment                                                 |  |                                | ---       
|Bad debt recovery                                                          |  |                                | (117,095  
|Changes in Assets and Liabilities                                          |  |                                |           
|Accounts receivable                                                        |  |                                | 147,650   
|Inventories                                                                |  |                                | (321,311  
|Prepaid and other current assets                                           |  |                                | 242,720   
|Accounts payable, accrued expenses and other current liabilities           |  |                                | (960,122  
|Deferred revenues and Customer deposits                                    |  |                                | (6,667    
|NET CASH USED IN OPERATING ACTIVITIES                                      |  |                                | (1,588,019
|CASH FLOWS FROM INVESTING ACTIVITIES                                       |  |                                |           
|Purchases of property, equipment and leasehold improvements                |  |                                | (1,405,633
|Costs incurred for intellectual property assets                            |  |                                | (17,893   
|Deposits to / (withdrawals from) restricted cash, net                      |  |                                | ---       
|Proceeds from Sale of Investment                                           |  |                                | ---       
|NET CASH USED IN INVESTING ACTIVITIES                                      |  |                                | (1,423,526
|                                                                           |  |                                |           
|CASH FLOWS FROM FINANCING ACTIVITIES                                       |  |                                |           
|Proceeds from sale of common shares                                        |  |                                | 2,780,142 
|Proceeds from exercise of cash warrants and options                        |  |                                | 2,328,255 
|Proceeds / (Payments) from draws against credit lines from related parties |  |                                | (171,362  
|Payment of bonds Principal                                                 |  |                                | (210,000  
|Other loan payments                                                        |  |                                | (148,582  
|Costs associated with raising capital                                      |  |                                | ---       
|NET CASH PROVIDED BY FINANCING ACTIVITIES                                  |  |                                | 4,578,453 
|                                                                           |  |                                |           
|NET CHANGE IN CASH AND CASH EQUIVALENTS                                    |  |                                | 1,566,908 
|                                                                           |  |                                |           
|CASH AND CASH EQUIVALENTS – beginning of period                            |  |                                | 7,464,180 
|CASH AND CASH EQUIVALENTS – end of period                                  |  | $                              | 9,031,088 
|SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION                          |  |                                |           
|Cash paid for interest                                                     |  | $                              | 110,372   
|Non-Cash Financing Transactions                                            |  |                                |           
|Financing of equipment purchases and insurance renewal                     |  |                                | 65,794    
|Commitment shares issued to Lincoln Park Capital                           |  |                                | 830,515   
|Conversion of Preferred Shares to Common Shares                            |  |                                | ---       



The accompanying notes are an integral
part of the condensed consolidated financial statements



F-5







ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY



NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS

THREE AND SIX MONTHS ENDED SEPTEMBER
30, 2015 AND 2014

(UNAUDITED)





|NOTE 1 | - | DEFINITIONS
|------ | - | -----------



“Current Balance Sheet
Date” means September 30, 2015



“Current Fiscal Year”
means the twelve months ended March 31, 2016



“Current Quarter”
means the three months ended September 30, 2015



“Current YTD”
means the six months ended September 30, 2015



“FDA” means
the U.S. Food and Drug Administration



“Hakim Credit Line Limit”
equals $1,000,000



“Hakim Credit Line Balance”
equals $411,709



“Hakim Credit Line Interest
Due”equals $41,658



“Prior Year Balance Sheet
Date” means September 30, 2014



“Prior Fiscal Year”
means the twelve months ended March 31, 2015



“Prior Year Quarter”
means the three months ended September 30, 2014



“SEC” means
the Securities and Exchange Commission





|NOTE 2 | - | BASIS OF PRESENTATION
|------ | - | ---------------------



The information in this quarterly
report on Form 10-Q includes the results of operations of Elite Pharmaceuticals, Inc. and its consolidated subsidiaries (collectively
the “Company” or “Elite”) for the Current Quarter and Prior Year Quarter. The accompanying unaudited condensed
consolidated financial statements have been prepared pursuant to rules and regulations of the Securities and Exchange Commission
in accordance with accounting principles generally accepted for interim financial statement presentation. Accordingly, they do
not include all of the information and footnotes required by accounting principles generally accepted in the United States of
America (“GAAP”) for complete financial statements. In the opinion of management, all adjustments (consisting of normal
recurring accruals) considered necessary for a fair presentation of the condensed consolidated financial position, results of
operations and cash flows of the Company for the periods presented have been included.



The financial results for the
interim periods are not necessarily indicative of the results to be expected for the full year or future interim periods.



The accompanying unaudited condensed
consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in
the Company’s Annual Report on Form 10-K for the year ended March 31, 2015 and filed with the SEC on June 15, 2015. There
have been no changes in significant accounting policies since March 31, 2015.



F-6









There have been no changes in
significant accounting policies since March 31, 2015, other than the accounting for convertible preferred share mezzanine as discussed
in Note 12 to these financial statements, with such changes to be considered when reviewing the Annual Report on Form 10-K filed
with the SEC on June 15, 2015.



The Company does not anticipate
being profitable for the Current Fiscal Year; therefore a current provision for income tax was not established for the Current
Quarter. Only the minimum liability required for state corporation taxes was considered.



Collaborative Arrangements



Contracts are considered to be
collaborative arrangements when they satisfy the following criteria defined in ASC 808, “Collaborative Arrangements”:



| | · | The parties to the contract must actively
participate in the joint operating activity; and
| | - | ------------------------------------------------------------------------------------------

| | · | The joint operating activity must expose
the parties to the possibility of significant risks and rewards, based on whether or not the activity is successful.
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------



The Company entered into a sales
and distribution licensing agreement with Epic Pharma LLC, dated June 9, 2015 (the “Epic Collaborative Agreement”),
which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly,
in accordance with GAAP.



Revenue Recognition





The
Company enters into licensing, manufacturing and development agreements which may include multiple revenue generating activities,
including, without limitation, milestones, license fees, product sales and services. These multiple elements are assessed in accordance
ASC 605-25 Revenue Recognition for Multiple-Element Arrangementsin order to determine whether particular components of
the arrangement represent separate units of accounting.



An
arrangement component is considered to be a separate unit of accounting if the deliverable relating to the component has value
to the customer on a standalone basis, and if the arrangement includes a general right of return relative to the delivered item,
delivery or performance of the undelivered item is considered probable and substantially in control of the Company.



The
Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s)
have stand-alone value and the fair value can be determined, with the arrangement being accordingly accounted for as a separate
unit of accounting. If such delivered item(s) are considered to either not have stand-alone value, or if the fair value cannot
be determined, the arrangement is accounted for as a single unit of accounting, and the payments received are recognized as revenue
over the estimated period of when performance obligations relating to the item(s) will be performed.



Whenever
the Company determines that an arrangement should be accounted for as a single unit of accounting, we determine the period over
which the performance obligations will be performed and revenue will be recognized. If we cannot reasonably estimate the timing
and the level of effort to complete our performance obligations under a multiple-element arrangement, revenues are then recognized
on a straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed
at each subsequent reporting period.



F-7







Segment Reporting



FASB ASC 280-10-50, “Disclosure
about Segments of an Enterprise and Related Information” requires use of the “management approach” model for
segment reporting. The management approach is based on the way a company’s management organizes segments within the company
for making operating decisions and assessing performance. Reportable segments are based on products and services, geography, legal
structure, management structure, or any other manner in which management disaggregates a company. The Company disaggregates its
product revenues into the type of marketing authorization relating to each product, specifically ANDA’s for generic products
or NDA’s for branded products.





During the three and six months
ended September 30, 2015 and 2014, the Company recognized $4,776k and $2,696k from the sale of generic products respectively. During
the three and six months ended September 30, 2015 and 2014, the Company recognized $5,000k and none, respectively for branded products,
including payments received for the research and development of products for which NDA’s are expected to be filed.







|NOTE 3 | - | Significant Accounting Policies And Estimates
|------ | - | ---------------------------------------------



Management’s discussion
addresses our Consolidated Financial Statements, which have been prepared in accordance with accounting principles generally accepted
in the United States of America. The preparation of these financial statements requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of
financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management
evaluates its estimates and judgment, including those related to bad debts, intangible assets, income taxes, workers compensation,
and contingencies and litigation. Management bases its estimates and judgments on historical experience and on various other factors
that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.



Management believes the following
critical accounting policies, among others, affect its more significant judgments and estimates used in the preparation of its
Consolidated Financial Statements. Our most critical accounting policies include the recognition of revenue upon completion of
certain phases of projects under research and development contracts. We also assess a need for an allowance to reduce our deferred
tax assets to the amount that we believe is more likely than not to be realized. We assess the recoverability of inventory, long-lived
assets and intangible assets whenever events or changes in circumstances indicate that the carrying value of the asset may not
be recoverable. We assess our exposure to current commitments and contingencies. It should be noted that actual results may differ
from these estimates under different assumptions or conditions.





Accounts receivable are comprised
of balances due from customers net of estimated allowances for uncollectible accounts. In determining collectability, historical
trends are evaluated and specific customer issues are reviewed to arrive at appropriate allowances.



The accounting treatment of warrants
and preferred share series issued is determined pursuant to the guidance provided by subtopics 470, 480, 815 and 270 of the Accounting
Standard Codification. Each feature of these instruments, including, without limitation, any rights relating to subsequent dilutive
issuances, dividend issuances, equity sales, rights offerings, forced conversions, optional redemptions, automatic monthly conversions,
dividends and exercise are assessed with determinations made regarding the proper classification on the Company’s statement
of financial position, results of operations, cash flow statement and statement of changes in equity.







|NOTE 4 | - | CASH AND CASH EQUIVALENTS
|------ | - | -------------------------



Cash consists of cash on deposit
with banks and money market instruments. The Company places its cash with high quality, U.S. financial institutions and, to date,
has not experienced losses on any of its balances.



F-8









|NOTE 5 | - | INVENTORIES
|------ | - | -----------



Inventories consist of raw materials,
work in process and finished goods and are stated at the lower of cost (first-in, first-out basis) or market (net realizable value),
and summarized as follows:



|                |  | September 30,
 2015 |           |  | March 31,
 2015 |  
|--------------- |  | ------------------- | --------- |  | --------------- | -
|Raw Materials   |  | $                   | 3,015,384 |  |                 | $
|Work-in-Process |  |                     | 160,080   |  |                 |  
|Finished Goods  |  |                     | 177,849   |  |                 |  
|Total Inventory |  | $                   | 3,353,313 |  |                 | $





|NOTE 6 | - | NJEDA
BONDS
|------ | - | -----------



Bond financing consisting
of the following, as of:



|                                             |  | September 30 2015 |           |   | March 31 2015 |  
|-------------------------------------------- |  | ----------------- | --------- | - | ------------- | -
|Refinanced NJEDA Bonds                       |  | $                 | 2,065,000 |   |               | $
|                                             |  |                   |           |   |               |  
|Current portion                              |  |                   | (220,000  | ) |               |  
|                                             |  |                   |           |   |               |  
|Long term portion, net of current maturities |  | $                 | 1,845,000 |   |               | $



Maturities of Bonds for the next five years are as follows:



|YEAR ENDING SEPTEMBER 30, |  | AMOUNT |          
|------------------------- |  | ------ | ---------
|2016                      |  |        | 220,000  
|2017                      |  |        | 85,000   
|2018                      |  |        | 90,000   
|2019                      |  |        | 95,000   
|2020                      |  |        | 105,000  
|Thereafter                |  |        | 1,470,000
|                          |  | $      | 2,065,000





|NOTE 7 | - | INTANGIBLE ASSETS
|------ | - | -----------------





Costs to acquire intangible assets
are capitalized and if such assets are determined to have a finite useful life, amortized to expense on a straight-line method
over this finite useful life. Costs to acquire intangible assets that are determined to be indefinitely lived, such as Abbreviated
New Drug Applications (“ANDA’s”) are capitalized, but not amortized to expense.



Patent application costs capitalized
were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of such patent costs will begin
upon the issuance of marketing authorization by the FDA of a product incorporating such patented technology and be calculated on
a straight line basis through the expiry of the related patent(s).



All intangible assets are tested
for impairment on at least an annual basis, or sooner should events or changes in circumstances occur that may indicate a potential
impairment of a listed intangible asset.



F-9







As of September 31, 2015 and March
31, 2015, the following costs were recorded as intangible assets on the Company’s balance sheet:





|                                                          |  | September 30, |           |  | March 31, |  
|--------------------------------------------------------- |  | ------------- | --------- |  | --------- | -
|                                                          |  | 2015          |           |  | 2015      |  
|Intangible assets at beginning of fiscal year             |  |               |           |  |           |  
|Patent application costs                                  |  | $             | 334,457   |  |           | $
|ANDA acquisitions                                         |  |               | 6,047,317 |  |           |  
|Less: Accumulated Amortization                            |  |               | ---       |  |           |  
|Net Intangible Assets at beginning of fiscal year         |  | $             | 6,381,774 |  |           | $
|                                                          |  |               |           |  |           |  
|Intangible asset costs capitalized during the fiscal year |  |               |           |  |           |  
|Patent application costs                                  |  | $             | 17,893    |  |           | $
|ANDA acquisition costs                                    |  |               | ---       |  |           |  
|Total cost of intangible assets capitalized               |  | $             | 17,893    |  |           | $
|                                                          |  |               |           |  |           |  
|Intangible assets at end of fiscal period                 |  |               |           |  |           |  
|Patent application costs                                  |  | $             | 352,350   |  |           | $
|ANDA acquisitions                                         |  |               | 6,047,317 |  |           |  
|Less: Accumulated Amortization                            |  |               | ---       |  |           |  
|Net Intangible Assets                                     |  | $             | 6,399,667 |  |           | $









|NOTE 8 | - | PROPERTY AND EQUIPMENTS
|------ | - | -----------------------





Property and equipment are stated
at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective assets which
range from five to forty years. Major repairs or improvements are capitalized. Minor replacements and maintenance and repairs which
do not improve or extend asset lives are expensed currently.



Upon retirement or other disposition
of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss, if any,
is recognized in income.



As of September 31, 2015 and March
31, 2015, the following costs were recorded as Property and Equipment on the Company’s balance sheet:



|                                                |  | September 30, |            |  | March 31, |  
|----------------------------------------------- |  | ------------- | ---------- |  | --------- | -
|                                                |  | 2015          |            |  | 2015      |  
|Computer
    Equipment                          |  | $             | 135,003    |  |           | $
|Furniture and Fixtures                          |  |               | 49,804     |  |           |  
|Land                                            |  |               | 300,000    |  |           |  
|Building Improvement                            |  |               | 3,245,307  |  |           |  
|Lease Improvement                               |  |               | 1,959,753  |  |           |  
|Lab Equipment                                   |  |               | 1,280,932  |  |           |  
|Manufacturing Equipment                         |  |               | 6,664,696  |  |           |  
|Warehouse Equipment                             |  |               | 168,342    |  |           |  
|Office Equipment                                |  |               | 76,654     |  |           |  
|Vehicles                                        |  |               | 66,855     |  |           |  
|Total                                           |  | $             | 13,947,346 |  |           | $
|Less: Accumulated depreciation and amortization |  |               | 6,392,827  |  |           |  
|Property and equipment, net                     |  | $             | 7,554,519  |  |           | $









F-10







Depreciation Expense for six months
ended on September 30, 2015 and 2014 was $318,711 and $463,609 respectively.



Fixed assets with a cost of $1.96
million have not yet been placed in service as of the Current Balance Sheet Date.







|NOTE 9 | - | LOANS PAYABLE
|------ | - | -------------



During the ordinary course of
business, the Company has secured loans to support the collateralized financing of fixed asset acquisitions, or the renewal of
insurance policies. During the six months ended September 30, 2015, the Company has secured such loans with initial principal
amounts totaling $66k and with payment terms of 60 months.



Loans Payable consisted of
the following as of:



|                                             |  | September 30 2015 |         |  | March 31 2015 |  
|-------------------------------------------- |  | ----------------- | ------- |  | ------------- | -
|Total loans                                  |  | $                 | 742,716 |  |               | $
|Current Portion                              |  |                   | 251,836 |  |               |  
|Long-term portion, net of current maturities |  | $                 | 490,880 |  |               |  





Principal payments on loans
for 12 months ending September 30:



|2016                     |  | $ | 251,835 | 
|------------------------ |  | - | ------- | 
|2017                     |  |   | 228,006 | 
|2018                     |  |   | 114,994 | 
|2019                     |  |   | 105,148 | 
|2020                     |  |   | 42,733  | 
|Thereafter               |  |   | ---     | 
|Total Principal Payments |  | $ | 742,716 | 









|NOTE 10 | - | WARRANT DERIVATIVE LIABILITIES
|------- | - | ------------------------------







Accounting Standard Codification
“ASC” 815 – Derivatives and Hedging, which provides guidance on determining what types of instruments
or embedded features in an instrument issued by a reporting entity can be considered indexed to its own stock for the purpose of
evaluating the first criteria of the scope exception in the pronouncement on accounting for derivatives. These requirements can
affect the accounting for warrants issued by the Company. As the warrants issued by the Company do not have fixed settlement provisions
because their exercise prices may be lowered if the Company issues securities at lower prices in the future, we have concluded
that the instruments are not indexed to the Company’s stock and are to be treated as derivative liabilities.



The portion of derivative liabilities
related to outstanding warrants was valued using the Black-Scholes option valuation model and the following assumptions on the
following dates:



|FAIR VALUE OF WARRANT DERIVATIVE LIABILITY
|------------------------------------------
|                                          
|Risk-Free interest rate                   
|Expected volatility                       
|Expected life (in years)                  
|Expected dividend yield                   
|Number of warrants                        
|                                          
|Fair Value of Warrant Derivative Liability



F-11









|CHANGE IN VALUE OF WARRANT DERIVATIVE LIABILITY
|-----------------------------------------------
|                                               
|                                               
|Change in Warrant Derivative Liability         



The risk free interest rate was
based on rates established by the U.S. Treasury Department. The expected volatility was based on the historical volatility of the
Company’s share price for periods equal to the expected life of the outstanding warrants at each valuation date. The expected
dividend rate was based on the fact that the Company has not historically paid dividends on common stock and does not expect to
pay dividends on common stock in the future.







|NOTE
11 | - | CONVERTIBLE PREFERRED SHARES MEZZANINE
EQUITY
|------- | - | ---------------------------------------------



On February 6, 2014, the Company
created the Series I Convertible Preferred Stock (“Series I Preferred”). A total of 500 shares of Series I Preferred
are authorized and as of the Current Balance Sheet Date, there are 100 shares issued and outstanding. The certificate of designations
(“COD”) for the Series I Preferred contain the following financial instruments:



| | · | Conversion Feature
| | - | ------------------

| | · | Subsequent Dilutive Issuances
| | - | -----------------------------

| | · | Subsequent Dividend Issuances
| | - | -----------------------------



Management has determined that
the Series I Preferred host instrument is more akin to equity than debt and also that the above financial instruments are clearly
and closely related to the host instrument, with bifurcation and classification as a derivative liability being not required.



Management has determined that
the Series I Preferred be classified as temporary equity, due to the floorless down round provisions included in the Series I
Preferred COD creating the possibility of a redemption event being not within the control of the Company. The Series I Preferred
is valued in temporary equity at its fair value, based upon the underlying value of common shares on an “as converted”
basis.



Since the Series I Preferred
is to be classified as temporary equity, changes in value are adjusted through additional paid-in capital, with such changes in
value being also subtracted from net income, (in a manner similar to the treatment of dividends paid on preferred stock), in arriving
at income available to common stockholders in the calculation of earnings per share.



|                                           |  | Series I Convertible Preferred Mezzanine Equity |            
|------------------------------------------ |  | ----------------------------------------------- | -----------
|                                           |  | March 31 2015                                   |            
|Shares Authorized                          |  |                                                 | 500        
|Shares Outstanding                         |  |                                                 | 100        
|Common shares to be issued upon redemption |  |                                                 | 142,857,143
|Closing price on valuation date            |  | $                                               | 0.2450     
|Fair value of temporary equity             |  | $                                               | 35,000,000 
|                                           |  |                                                 |            





F-12







|                   |  | (Increase)/Decrease in Value of Convertible Preferred Stock |           
|------------------ |  | ----------------------------------------------------------- | ----------
|                   |  | Three Months Ended Sept 30,                                 |           
|                   |  | 2015                                                        |           
|Series I Preferred |  |                                                             | (5,071,406



Please see Note 12 below.







| | NOTE 12 | - | RECLASSIFICATION OF CONVERTIBLE
PREFERRED SHARES
| | ------- | - | ------------------------------------------------



The Company has determined and reclassified
its convertible preferred shares from debt to a quasi equity instrument, which are recorded as mezzanine equity for financial reporting
purposes.



Amounts recorded as convertible preferred
share derivative liabilities are reclassified as convertible preferred share mezzanine equity of equal value. In addition, changes
in fair value of the convertible preferred shares are not included in the other income (expense) section of the statement of operations,
but are charged directly to additional paid in capital and included in the calculation of net income available to common shareholders.



The effects of the reclassification
on the Company’s balance sheet are summarized as follows:



|                                                 |  | (amounts in 000’s)   |         
|------------------------------------------------ |  | -------------------- | --------
|                                                 |  | As of March 31, 2015 |         
|                                                 |  | As Reported          |         
|Convertible Preferred Share Derivative Liability |  |                      | 35,000  
|Convertible Preferred Share Mezzanine Equity     |  |                      | -0-     
|                                                 |  |                      |         
|Accumulated Deficit                              |  |                      | (196,077
|Additional Paid-In Capital                       |  |                      | 161,022 
|                                                 |  |                      |         



The effects of the reclassification
on the Company’s statement of operations for the three months ended September 30, 2014 are summarized as follows:



|                                                                  |  | (amounts in 000’s)                    |       
|----------------------------------------------------------------- |  | ------------------------------------- | ------
|                                                                  |  | Three Months Ended September 30, 2014 |       
|                                                                  |  | As Reported                           |       
|Change in fair value of convertible preferred share derivatives   |  |                                       | 15,132
|Net Income                                                        |  |                                       | 21,380
|                                                                  |  |                                       |       
|Change in fair value convertible preferred share mezzanine equity |  |                                       | -0-   
|Net Income Attributable to Common Shareholders                    |  |                                       | 21,380
|                                                                  |  |                                       |       





F-13







The effects of the reclassification
on the Company’s statement of operations for the six months ended September 30, 2014 are summarized as follows:



|                                                                  |  | (amounts in 000’s)                  |       
|----------------------------------------------------------------- |  | ----------------------------------- | ------
|                                                                  |  | Six Months Ended September 30, 2014 |       
|                                                                  |  | As Reported                         |       
|Change in fair value of convertible preferred share derivatives   |  |                                     | 12,823
|Net Income                                                        |  |                                     | 16,978
|                                                                  |  |                                     |       
|Change in fair value convertible preferred share mezzanine equity |  |                                     | -0-   
|Net Income Attributable to Common Shareholders                    |  |                                     | 16,978
|                                                                  |  |                                     |       





| | NOTE 13 | - | OPERATING LEASES
| | ------- | - | ----------------



The Company entered into a
lease for a portion of a one-story warehouse, located at 135-137 Ludlow Avenue, Northvale, New Jersey, consisting of approximately
15,000 square feet of floor space. The lease term began on July 1, 2010.



On July 29, 2014, the Company
modified this operating lease, with the material terms of the modification including the Company being permitted to occupy the
entire 35,000 square feet in the building.



The lease terms, as modified,
include an initial term that expires on December 31, 2016, and the Company has the option to renew the lease for two additional
terms of five years each. The lease is classified as an operating lease.





The property related to this
lease is used for the storage of pharmaceutical finished goods, raw materials, equipment and documents, as well as a site at which
the Company engages in manufacturing packaging and distribution activities, inclusive of regulatory support and compliance activities.



Minimum 5 year payments* for
the initial term for the leasing of 35,000 square feet at 135 Ludlow are as follows:





|12 MONTHS ENDING SEPTEMBER 30,      |  | AMOUNT |        
|----------------------------------- |  | ------ | -------
|2016                                |  |        | 205,878
|2017                                |  |        | 51,723 
|2018                                |  |        | ---    
|2019                                |  |        | ---    
|2020                                |  |        | ---    
|Total Minimum 5 year lease payments |  | $      | 257,601





* Minimum lease payments are
exclusive of additional expenses related to certain expenses incurred in the operation and maintenance of the premises, including,
without limitation, real estate taxes and common area charges which may be due under the terms and conditions of the lease, but
which are not quantifiable at the time of filing of this quarterly report on Form 10-Q.





F-14







Rent expense relating to the
operating lease is recorded using the straight line method, and is summarized as follows:



|                                  |  | RENT EXPENSE                                                                                                       |       
|--------------------------------- |  | ------------------------------------------------------------------------------------------------------------------ | ------
|                                  |  | Three
                                         months ended September
                                         30, |       
|                                  |  | 2015                                                                                                               |       
|Rent Expense                      |  | $                                                                                                                  | 45,214
|                                  |  |                                                                                                                    |       
|Change in deferred rent liability |  | $                                                                                                                  | (5,496



|                                   |  | DEFERRED RENT LIABILITY (LONG-TERM LIABILITY)        |       
|---------------------------------- |  | ---------------------------------------------------- | ------
|                                   |  | June
                                         302015 |       
|Balance of Deferred Rent Liability |  | $                                                    | 37,027



| | NOTE 14 | - | COMMON STOCK
| | ------- | - | ------------



During the Current YTD, the
Company issued shares of Common Stock, as follows:



|Description                                                                         |  | Shares Of Common
                                         Stock |           
|----------------------------------------------------------------------------------- |  | --------------------------------------------------------------- | ----------
|                                                                                    |  |                                                                 |           
|Common shares sold pursuant to the LPC-40 Purchase Agreement                        |  |                                                                 | 13,155,283
|                                                                                    |  |                                                                 |           
|Common shares issued as commitment shares pursuant to the LPC-40 Purchase Agreement |  |                                                                 | 134,047   
|                                                                                    |  |                                                                 |           
|Common shares issued pursuant to the exercise of cash warrants                      |  |                                                                 | 37,252,079
|                                                                                    |  |                                                                 |           
|Common Shares issued in payment of employee salaries                                |  |                                                                 | 54,169    
|                                                                                    |  |                                                                 |           
|Total Common Shares issued during the Current YTD                                   |  |                                                                 | 50,595,578



F-15







Options

Options issued and outstanding
as of the Current Balance Sheet Date are summarized as follows:



|                   |  | Number of Options |           |  | Range of Exercise Prices | 
|------------------ |  | ----------------- | --------- |  | ------------------------ | 
|Vested Options     |  |                   | 4,355,500 |  |                          | 
|Non-Vested Options |  |                   | 3,226,667 |  |                          | 



Each option represents the
right to purchase one share of common stock. The non-vested options are scheduled to vest in various increments during dates that
are within the period beginning on July 23, 2016 and through October 20, 2017, or upon the occurrence of certain defined events
and require that employees awarded such options be employed by the Company on the vesting date.



| | NOTE 15 | - | PER SHARE INFORMATION
| | ------- | - | ---------------------



Basic earnings per share of
common stock (“Basic EPS”) is computed by dividing the net (loss) income by the weighted-average number of shares
of common stock outstanding. Diluted earnings per share of common stock (“Diluted EPS”) are computed by dividing the
net (loss) income by the weighted-average number of shares of common stock, and dilutive common stock equivalents and convertible
securities then outstanding. GAAP requires the presentation of both Basic and Diluted EPS, if such Diluted EPS is not anti-dilutive,
on the face of Company’s Condensed Statements of Operations.



The calculation of Basic
EPS and Diluted EPS is summarized as follows:



|                                                                      |  | For
                                         the Three Months Ended
                                         September 30 |             |   | For
                                         the Six Months Ended
                                         September 30 |  
|--------------------------------------------------------------------- |  | ------------------------------------------------------------------------------------------------------------------------- | ----------- | - | ----------------------------------------------------------------------------------------------------------------------- | -
|                                                                      |  | 2015                                                                                                                      |             |   | 2014                                                                                                                    |  
|Numerator                                                             |  |                                                                                                                           |             |   |                                                                                                                         |  
|Net Income (loss) attributable to common shareholders –
    Basic     |  | $                                                                                                                         | (7,002,780  | ) |                                                                                                                         | $
|                                                                      |  |                                                                                                                           |             |   |                                                                                                                         |  
|Effect of dilutive instruments on Net Income                          |  |                                                                                                                           | 2,921,619   |   |                                                                                                                         |  
|                                                                      |  |                                                                                                                           |             |   |                                                                                                                         |  
|Net Income attributable to common shareholders
    – Diluted          |  | $                                                                                                                         | (4,081,161  | ) |                                                                                                                         | $
|                                                                      |  |                                                                                                                           |             |   |                                                                                                                         |  
|Denominator                                                           |  |                                                                                                                           |             |   |                                                                                                                         |  
|Weighted-average shares of common stock outstanding - basic           |  |                                                                                                                           | 665,330,431 |   |                                                                                                                         |  
|                                                                      |  |                                                                                                                           |             |   |                                                                                                                         |  
|Dilutive effect of stock options, warrants and convertible securities |  |                                                                                                                           | 158,164,848 |   |                                                                                                                         |  
|                                                                      |  |                                                                                                                           |             |   |                                                                                                                         |  
|Weighted average shares of common stock outstanding
    - diluted     |  |                                                                                                                           | 823,495,279 |   |                                                                                                                         |  
|                                                                      |  |                                                                                                                           |             |   |                                                                                                                         |  
|Net (loss) income per share                                           |  |                                                                                                                           |             |   |                                                                                                                         |  
|Basic                                                                 |  | $                                                                                                                         | (0.01       | ) |                                                                                                                         | $
|Diluted                                                               |  | $                                                                                                                         | (0.00       | ) |                                                                                                                         | $





| | NOTE 16 | - | RELATED PARTY TRANSACTION AGREEMENTS
| | ------- | - | ------------------------------------





The Company has entered into
two agreements with Epic Pharma LLC (“Epic”) which constitute agreements with a related party due to the management
of Epic including a member on our Board of Directors.



F-16







On June 4, 2015, Elite executed an exclusive license agreement with Epic to market and sell, in the United States, ELI-200, an undisclosed opioid with sequestered naltrexone capsules, owned by Elite (the “ELI-200 Agreement”). As of the date of filing of this Quarterly Report on Form 10-Q, this product had not yet received marketing authorization from the FDA. Epic will have an exclusive right to market ELI-200 and its various dosage forms, subsequent to marketing authorization being granted by the FDA. ELI-200 will be manufactured by Elite. Epic is responsible for all regulatory and pharmacovigilance matters related to the ELI-200.





Pursuant
to the ELI-200 Agreement, Elite received $5 million for research and development activities completed prior to the agreement. Elite
will also receive milestone payments totaling $10 million upon the filing with and approval of a New Drug Application (“NDA”)
with the FDA. The Company has determined these milestones to be substantive, with such assessment being made at the inception of
the ELI-200 Agreement, and based on the following:





| | • | The Company’s performance is required to achieve each milestone; and                                             
| | - | -----------------------------------------------------------------------------------------------------------------
| | • | The milestones will relate to past performance, when achieved; and                                               
| | • | The milestones are reasonable relative to all of the deliverables and payment terms within the ELI-200 Agreement.





After marketing authorization is received from the FDA, Elite will receive a license fee which is based on profits achieved from the commercial sales of ELI-200. There can be no assurances of the Company filing an NDA and receiving marketing authorization for ELI-200, and accordingly, there can be no assurances that the Company will earn and receive the additional $10 million or future license fees. If the Company does not receive these payments or fees, it most likely will materially and adversely affect our financial condition.



On October 2, 2013, Elite executed the Epic Pharma Manufacturing and License Agreement (the “Epic Generic Agreement”), which granted rights to Epic to manufacture twelve generic products whose ANDA’s are owned by Elite, and to market, in the United States and Puerto Rico, six of these products on an exclusive basis, and the remaining six products on a non-exclusive basis. These products will be manufactured at Epic, with Epic being responsible for the manufacturing site transfer supplements that are a prerequisite to each product being approved for commercial sale. In addition, Epic is responsible for all regulatory and pharmacovigilance matters, as well as all marketing and distribution activities. Elite has no further obligations or deliverables under the Epic Generic Agreement.



Pursuant to the Epic Generic Agreement, Elite will receive $1.8 million, payable in increments that require the commercialization of all six exclusive products if the full amount is to be received, plus license fees which are based on profits achieved from commercial sales of the products. While Epic has launched four of the six exclusive products and Elite has collected $1.0 million of the $1.8 million total fee, collection of the remaining $800k is contingent upon Epic filing the required supplements with and receiving approval from the FDA for the remaining exclusive generic products. There can be no assurances of Epic filing these supplements, or getting approval of any supplements filed. Accordingly, there can be no assurances of Elite receiving the remaining $800k due under the Epic Generic Agreement, or future license fees related thereto. Please also note that all commercialization, regulatory, manufacturing, marketing and distribution activities are being conducted solely by Epic, without Elite’s participation.



F-17









Both
the ELI-200 Agreement and the Epic Generic Agreement contain license fees that will be earned and payable to the Company, after
the FDA has issued marketing authorization(s) for the related product(s). License fees are based on commercial sales of the products
achieved by Epic and calculated as a percentage of net sales dollars realized from such commercial sales. Net sales dollars consist
of gross invoiced sales less those costs and deductions directly attributable to each invoiced sale, including, without limitation,
cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments, returns, short date adjustments,
charge backs, promotions and marketing costs. The rate applied to the net sales dollars to determine license fees due to the Company
is equal to an amount negotiated and agreed to by the parties to each agreement, with the following significant factors, inputs,
assumptions and methods, without limitation, being considered by either or both parties:





| | • | Assessment of the opportunity for each product in the market, including consideration of the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative and social environment for abuse deterrent opioids and the other generic products to which the underlying contracts are relevant;
| | - | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | • | Assessment of various avenues for monetizing ELI-200 and the twelve ANDA’s owned by the Company, including the various combinations of sites of manufacture and marketing options;                                                                                                                                                                        
| | • | Elite’s resources and capabilities with regards to the concurrent development of abuse deterrent opioids and expansion of its generic business segment, including financial and operational resources required to achieve manufacturing site transfers for twelve approved ANDA’s;                                                                        
| | • | Capabilities of each party with regards to various factors, including, one or more of the following: manufacturing, marketing, regulatory and financial resources, distribution capabilities, ownership structure, personnel, assessments of operational efficiencies and entity stability, company culture and image;                                    
| | • | Stage of development of ELI-200 and manufacturing site transfer and regulatory requirements relating to the commercialization of the generic products at the time of the discussions/negotiations, and an assessment of the risks, probability and time frames for achieving marketing authorizations from the FDA for each product.                      
| | • | Assessment of consideration offered; and                                                                                                                                                                                                                                                                                                                  
| | • | Comparison of the above factors among the various entities with whom the Company was engaged in discussions relating to the commercialization of ELI-200 and the manufacture/marketing of the twelve generics related to the Epic Generic Agreement.                                                                                                      







| | NOTE 17 | - | MANUFACTURING LICENSE AND DEVELOPMENT AGREEMENTS
| | ------- | - | ------------------------------------------------





The Company has entered into the following agreements:



| | • | License agreement with Precision
                                         Dose, dated September 10, 2010 (the “Precision Dose License Agreement”)
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Manufacturing and Supply Agreement
                                         with Ascend Laboratories Inc., dated June 23, 2011 and as amended on September 24, 2012
                                         and January 19, 2015 (the “Ascend Manufacturing Agreement”)
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Development and license agreement
                                         with a private, Hong Kong based company, dated March 16, 2012 (the “Hong Kong Development
                                         Agreement”); and
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Development agreement with
                                         Akorn Pharmaceuticals, dated January 10, 2011 (the “Akorn Agreement”).
| | - | ------------------------------------------------------------------------------------------------------------------------------------------



The Precision Dose Agreement
provides for the marketing and distribution, by Precision Dose and its wholly owned subsidiary, TAGI Pharma, of Phentermine 37.5mg
tablets (launched in April 2011), Phentermine 15mg capsules (launched in April 2013), Phentermine 30mg capsules (launched in April
2013), Hydromorphone 8mg tablets (launched in March 2012), Naltrexone 50mg tablets (launched in September 2013) and certain additional
products that require approval from the FDA which has not been received. Precision Dose will have the exclusive right to market
these products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada. Pursuant to the
Precision Dose License Agreement, Elite received $200k at signing, and is receiving milestone payments and a license fee which
is based on profits achieved from the commercial sale of the products included in the agreement.



F-18







Revenue from the $200k payment
made upon signing of the Precision Dose Agreement is being recognized over the life of the Precision Dose Agreement.



The milestones, totaling $500k,
consist of amounts due upon the first shipment of each identified product, as follows: Phentermine 37.5mg tablets ($145k), Phentermine
15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance of $95k due in relation to the
first shipment of generic products which still require marketing authorizations from the FDA, and to which there can be no assurances
of such marketing authorizations being granted and accordingly there can be no assurances that the Company will earn and receive
these milestone amounts. These milestones have been determined to be substantive, with such determination being made by the Company
after assessments based on the following:



| | • | The Company’s performance
                                         is required to achieve each milestone; and
| | - | -------------------------------------------------------------------------------------------------------------

| | • | The milestones will relate
                                         to past performance, when achieved; and
| | - | -----------------------------------------------------------------------------------------------------------

| | • | The milestones are reasonable
                                         relative to all of the deliverables and payment terms within the Precision Dose License
                                         Agreement.
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The license fees provided for
in the Precision Dose Agreement are calculated as a percentage of net sales dollars realized from commercial sales of the related
products. Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each invoiced
sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments,
returns, short date adjustments, charge backs, promotions and marketing costs. The rate applied to the net sales dollars to determine
license fees due to the Company is equal to an amount negotiated and agreed to by the parties to the Precision Dose License Agreement,
with the following significant factors, inputs, assumptions and methods, without limitation, being considered by either or both
parties:



| | • | Assessment of the opportunity
                                         for each generic product in the market, including consideration of the following, without
                                         limitation: market size, number of competitors, the current and estimated future regulatory,
                                         legislative and social environment for each generic product, and the maturity of the
                                         market;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Assessment of various avenues
                                         for monetizing the generic products, including the various combinations of sites of manufacture
                                         and marketing options;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Capabilities of each party
                                         with regards to various factors, including, one or more of the following: manufacturing
                                         resources, marketing resources, financial resources, distribution capabilities, ownership
                                         structure, personnel, assessment of operational efficiencies and stability, company culture
                                         and image;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Stage of development of each
                                         generic products, all of which did not have FDA approval at the time of the discussions/negotiations
                                         and an assessment of the risks, probability and time frame for achieving marketing authorizations
                                         from the FDA for the products;
| | - | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Assessment of consideration
                                         offered by Precision and other entities with whom discussions were conducted; and
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------

| | • | Comparison of the above factors
                                         among the various entities with whom the Company was engaged in discussions relating
                                         to the commercialization of the generic products.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------





The Ascend Manufacturing Agreement
provides for the manufacturing by Elite of Methadone 10mg for supply to Ascend Laboratories LLC (“Ascend”). Ascend
is the owner of the approved ANDA for Methadone 10mg, and the Northvale Facility is an approved manufacturing site for this ANDA.
There are no license fees or milestones relating to this agreement. All revenues earned are recognized as manufacturing revenues
on the date of shipment of the product, when title for the goods is transferred, and for which the price is agreed to and it has
been determined that collectability is reasonably assured. The initial shipment of Methadone 10mg pursuant to the Ascend Manufacturing
Agreement occurred in January 2012.



F-19







The Hong Kong Development Agreement
provides for Elite to develop a branded prescription pharmaceutical product (the “Prescription Product”) for a private
Hong Kong-based company (the “Hong Kong Customer”). There is currently no development activity being conducted pursuant
to this agreement, and there was no activity conducted during the last fiscal year as well. There can be no assurances that development
activities will resume or that a resumption of development activities will result in the successful development of the relevant
product.



The Akorn Agreement was executed
on January 10, 2011 between Hi-Tech Pharmacal Inc. (subsequently acquired by Akorn Pharmaceuticals) and provides for Elite to
develop an intermediate product which will be incorporated into the finished formulation of a generic version of a prescription
product for Akorn Pharmaceuticals (“Akorn”). There is currently no development activity being conducted pursuant to
this agreement and there was no activity during the last fiscal year as well. There can be no assurances that development activities
will resume or that a resumption of development activities will result in the successful development of the relevant product.



| | NOTE 18 | - | SALE OF INVESTMENT IN NOVEL LABORATORIES
| | ------- | - | ----------------------------------------





At the end of 2006, Elite entered
into a joint venture with VGS Pharma, LLC (“VGS”) and created Novel Laboratories, Inc. (“Novel”),
a privately-held company specializing in pharmaceutical research, development, manufacturing, licensing, acquisition and marketing
of specialty generic pharmaceuticals.



On June 10, 2014, the Company
received $5 million in exchange for its investment in Novel’s Class A Voting Common Stock.





| | NOTE 19 | - | CONCENTRATIONS
| | ------- | - | --------------







Revenue Concentrations

Three customers accounted for
approximately 90% of the Company’s revenues for the six months ended September 30, 2015. Included in these are three customers
that accounted for approximately 54%, 24% and 19% of revenues each, respectively.



Three customers accounted for
more than 90% of the Company’s revenues for the six months ended September 30, 2014. Included in these are three customers
that accounted for approximately 60%, 18% and 60% of revenues each, respectively.



Accounts Receivable Concentrations

Two customers accounted for
more than 90% of the Company’s accounts receivable as of September 30, 2015. Included in these are two customers that accounted
for approximately 56% and 36% of accounts receivable, respectively.



Three customers accounted for
more than 90% of the Company’s accounts receivable as of September 30, 2014. Included in these are three customers that accounting
for approximately 44%, 36% and 10% of accounts receivable, respectively.





Purchasing Concentrations

Five suppliers accounted for
more than 80% of the Company’s purchases of raw materials for the six months ended September 30, 2015. Included in these
five suppliers are two suppliers that accounted for approximately 44% and 17% of raw material purchases for the period, respectively.



Five suppliers accounted for
more than 80% of the Company’s purchases of raw materials for the six months ended September 30, 2014. Included in these
five suppliers are three suppliers that accounted for approximately 44%, 14% and 11% of raw material purchases for this period,
respectively.



F-20









| | NOTE 20 | - | LEGAL PROCEEDINGS
| | ------- | - | -----------------



In the ordinary course of business
we may be subject to litigation from time to time. Except as discussed below, there is no current, pending or, to our knowledge,
threatened litigation or administrative action to which we are a party or of which our property is the subject (including litigation
or actions involving our officers, directors, affiliates, or other key personnel, or holders of record or beneficially of more
than 5% of any class of our voting securities, or any associate of any such party) which in our opinion has, or is expected to
have, a material adverse effect upon our business, prospects financial condition or operations.





Arbitration with Precision
Dose, Inc.



On May 9, 2014, Precision Dose
Inc., the parent company of TAGI Pharmaceuticals, Inc., commenced an arbitration against the Company alleging that the Company
failed to properly supply, price and satisfy gross profit minimums regarding Phentermine 37.5mg tablets, as required by the parties’
agreements. Elite denies Precision Dose’s allegations and has counterclaimed that Precision Dose is no longer entitled to
exclusivity rights with respect to Phentermine 37.5mg tablets, and is responsible for certain costs, expenses, price increases
and lost profits relating to Phentermine 37.5mg tablets and the parties’ agreements. As of the date of filing of this current
report on Form 10-Q the parties have reached agreement in settlement of these issues, with Precision Dose agreeing to pay certain
amounts to the Company in exchange for Elite agreeing to restore exclusivity rights with respect to Phentermine 37.5mg tablets,
subject to certain defined conditions. The Company has notified the Arbitrator of this settlement and is awaiting the Arbitrators
issuance of the proceeding termination document.



GAAP requires that a contingency
loss may only be recognized if the event is (1) probable and (2) the amount of the loss can be reasonably estimated. There were
no liabilities of this type at September 30, 2015.









| | NOTE 21 | - | EQUITY LINE WITH LINCOLN PARK CAPITAL FUND LLC
| | ------- | - | ----------------------------------------------



On April 10, 2014, we entered
into a purchase agreement (the “LPC-40 Purchase Agreement”), together with a registration rights agreement (the “Registration
Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”).



Under the terms and subject
to the conditions of the LPC-40 Purchase Agreement, the Company has the right to sell to and Lincoln Park is obligated to purchase
up to $40 million in shares of the Company’s common stock (“Common Stock”), subject to certain limitations,
from time to time, over the 36-month period commencing on the date that a registration statement, which the Company agreed to
file with the Securities and Exchange Commission (the “SEC”) pursuant to the Registration Rights Agreement, is declared
effective by the SEC and a final prospectus in connection therewith is filed. The Company may direct Lincoln Park, at its sole
discretion and subject to certain conditions, to purchase up to 500,000 shares of Common Stock on any business day, provided that
at least one business day has passed since the most recent purchase, increasing to up to 800,000 shares, depending upon the closing
sale price of the Common Stock (such purchases, “Regular Purchases”). However, in no event shall a Regular Purchase
be more than $760,000. The purchase price of shares of Common Stock related to the future funding will be based on the prevailing
market prices of such shares at the time of sales, but in no event will shares be sold to Lincoln Park on a day the Common Stock
closing price is less than the floor price as set forth in the LPC-40 Purchase Agreement. In addition, the Company may direct
Lincoln Park to purchase additional amounts as accelerated purchases if on the date of a Regular Purchase the closing sale price
of the Common Stock is not below the threshold price as set forth in the LPC-40 Purchase Agreement. The Company’s sales
of shares of Common Stock to Lincoln Park under the Purchase Agreement are limited to no more than the number of shares that would
result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 9.99% of the
then outstanding shares of the Common Stock.



F-21







In connection with the LPC-40
Purchase Agreement, the Company issued to Lincoln Park 1,928,641 shares of Common Stock and is required to issue up to 1,928,641
additional shares of Common Stock pro rata as the Company requires Lincoln Park to purchase the Company’s shares under the
Purchase Agreement over the term of the agreement. Lincoln Park represented to the Company, among other things, that it was an
“accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as
amended (the “Securities Act”)), and the Company sold the securities in reliance upon an exemption from registration
contained in Section 4(2) under the Securities Act. The securities sold may not be offered or sold in the United States absent
registration or an applicable exemption from registration requirements.



The LPC-40 Purchase Agreement
and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future
sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the LPC-40 Purchase
Agreement at any time, at no cost or penalty. Actual sales of shares of Common Stock to Lincoln Park under the LPC-40 Purchase
Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market
conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for
the Company and its operations. There are no trading volume requirements or restrictions under the LPC-40 Purchase Agreement.
Lincoln Park has no right to require any sales by the Company, but is obligated to make purchases from the Company as it directs
in accordance with the LPC-40 Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever,
any direct or indirect short selling or hedging of our shares.



The net proceeds under the
LPC-40 Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock
to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park under the Purchase
Agreement will be used for general corporate purposes and working capital requirements.



A Registration
Statement on Form S-1 was filed with the SEC in relation to this transaction with Lincoln Park and it was declared effective by
the SEC as of May 1, 2014. A post-effective amendment to the Registration Statement was subsequently filed with the SEC and declared
effective on July 1, 2014.



During the six months ended
September 30, 2015, a total of 13,155,283 shares of Common Stock were sold to Lincoln Park pursuant to the Purchase Agreement,
with the proceeds of such sales of Common Stock totaling $2,780,142. An additional 134,047 shares of Common Stock were issued
to Lincoln Park during this same period with such shares constituting additional commitment shares issued pursuant to the Purchase
Agreement.



During the six months ended
September 30, 2014, a total of 19,004,103 shares of Common Stock were sold to Lincoln Park pursuant to the Purchase Agreement,
with the proceeds of such sales of Common Stock totaling $6,227,485. An additional 300,269 shares of Common Stock were issued
to Lincoln Park during this same period with such constituting initial commitment shares and additional commitment shares issued
pursuant to the Purchase Agreement.



F-22







| | NOTE 22 | - | SUBSEQUENT EVENTS
| | ------- | - | -----------------





Common shares issued pursuant
to the strategic alliance agreement with Epic Investments LLC.

A total of 3 million shares of
Common Stock were issued to Epic Investments LLC pursuant to the Strategic Alliance Agreement dated March 18, 2009, as amended
on April 30, 2009, June 1, 2009, and July 28, 2009 (the “Epic Strategic Alliance”), upon Epic’s notification
to the Company of the FDA’s approval of the ANDA filed by Epic for immediate release oxycodone tablets. This product was
developed at the Northvale facility. As per the Epic Strategic Alliance, Elite is entitled to 15% of the profits achieved from
the commercial sales of this product for a 10 year period commencing on the date of first commercial shipment and Epic is to receive
3 million shares of Common Stock upon approval by the FDA of the ANDA.







F-23







ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS



THREE AND SIX MONTHS ENDED SEPTEMBER 30,
2015

COMPARED TO THE

THREE AND SIX MONTHS ENDED SEPTEMBER 30,
2014

(UNAUDITED)



The following discussion
and analysis should be read with the financial statements and accompanying notes included elsewhere in this Form 10-Q and in the
Annual Report on Form 10-K for the year ended March 31, 2015. It is intended to assist the reader in understanding and evaluating
our financial position.



This Quarterly Report on Form 10-Q and the
documents incorporated herein contain “forward-looking statements”. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company,
or industry results, to be materially different from any future results, performance or achievements expressed or implied by such
forward-looking statements. When used in this Form 10-Q, statements that are not statements of current or historical fact may be
deemed to be forward-looking statements. Without limiting the foregoing, the words “plan”, “intend”, “may,”
“will,” “expect,” “believe”, “could,” “anticipate,” “estimate,”
or “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking
statements. All statements other than statements of historical fact included in this Form 10-Q regarding our financial position,
business strategy and plans or objectives for future operations are forward-looking statements. Without limiting the broader description
of forward-looking statements above, we specifically note, without limitation, that statements regarding the preliminary nature
of the clinical program results and the potential for further product development, that involve known and unknown risks, delays,
uncertainties and other factors not under our control, the requirement of substantial future testing, clinical trials, regulatory
reviews and approvals by the Food and Drug Administration and other regulatory authorities prior to the commercialization of products
under development, and our ability to manufacture and sell any products, gain market acceptance, earn a profit from sales or licenses
of any drugs or our ability to discover new drugs in the future, are all forward-looking in nature. These risks and other factors
are discussed in our filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company undertakes no
obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.



Any reference to “Elite”, the
“Company”, “we”, “us”, “our” or the “Registrant” refers to Elite Pharmaceuticals
Inc. and its subsidiaries.



Overview

We are a specialty pharmaceutical company principally
engaged in the development and manufacture of oral, controlled-release products, using proprietary know-how and technology, particularly
as it relates to abuse resistant products. Our strategy includes improving off-patent drug products for life cycle management and
developing generic versions of controlled-release drug products with high barriers to entry.



We own and occupy manufacturing, warehouse,
laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale Facility”).
The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement
Agency (“DEA”) registered facility for research, development and manufacturing.



Strategy

Elite is focusing its efforts on the following
areas: (i) development of Elite’s pain management products; (ii) manufacturing of a line of generic pharmaceutical products
with approved ANDAs; (iii) development of additional generic pharmaceutical products; (iv) development of the other products in
our pipeline including the products with our partners; (v) commercial exploitation of our products either by license and the collection
of royalties, or through the manufacture of our formulations; and (vi) development of new products and the expansion of our licensing
agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.



1







Elite is focusing on the development of various
types of drug products, including branded drug products which require new drug applications (“NDAs”) under Section
505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “ Drug Price Competition
Act ”) as well as generic drug products which require ANDAs.



Elite believes that its business strategy enables
it to reduce its risk by having a diverse product portfolio that includes both branded and generic products in various therapeutic
categories and to build collaborations and establish licensing agreements with companies with greater resources thereby allowing
us to share costs of development and improve cash-flow.



Commercial Products

We own, license or contract manufacture the
following products currently being sold commercially:



|Product                                                                                                                        |  | BrandedProductEquivalent |  | TherapeuticCategory |  | Launch
Date   
|------------------------------------------------------------------------------------------------------------------------------ |  | ------------------------ |  | ------------------- |  | --------------
|Phentermine HCl 37.5mg tablets
        (“Phentermine 37.5mg”)                                                                  |  | Adipex-P®                |  | Bariatric           |  | April 2011    
|Lodrane D ® Immediate Release capsules
        (“Lodrane D”)                                                                   |  | n/a                      |  | OTC Allergy         |  | September 2011
|Methadone HCl 10mg tablets
        (“Methadone 10mg”)                                                                          |  | Dolophine®               |  | Pain                |  | January 2012  
|Hydromorphone HCl 8mg tablets
        (“Hydromorphone 8mg”)                                                                    |  | Dilaudid®                |  | Pain                |  | March 2012    
|Phendimetrazine Tartrate 35mg tablets
        (“Phendimetrazine 35mg”)                                                         |  | Bontril®                 |  | Bariatric           |  | November 2012 
|Phentermine HCl 15mg and 30mg capsules
        (“Phentermine 15mg” and “Phentermine 30mg”)                                     |  | Adipex-P®                |  | Bariatric           |  | April 2013    
|Naltrexone HCl 50mg tablets
        (“Naltrexone 50mg”)                                                                        |  | Revia®                   |  | Pain                |  | September 2013
|Isradipine 2.5mg and 5mg capsules
        (“Isradipine 2.5mg” and “Isradipine 5mg”)                                            |  | n/a                      |  | Cardiovascular      |  | January 2015  
|Hydroxyzine HCl 10mg, 25mg and 50mg tablets
        (“Hydroxyzine 10mg” and “Hydroxyzine 25mg”
        and “Hydroxyzine 50mg”) |  | Atarax®, Vistaril®       |  | Antihistamine       |  | April 2015    



Note: Phentermine 15mg and Phentermine 30mg
are collectively and individually referred to as “Phentermine Capsules”. Isradipine 2.5mg and Isradipine 5mg are collectively
and individually referred to as “Isradipine Capsules”. Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg are
collectively and individually referred to as “Hydroxyzine”.



Phentermine 37.5mg

The approved Abbreviated New Drug Application
“ANDA” for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (“Epic”)
dated September 10, 2010 (the “Phentermine Purchase Agreement”). For further details on the Phentermine Purchase Agreement,
please see exhibit 10.7 to the Quarterly Report on Form 10-Q, filed with the SEC on November 15, 2010, with such filing being herein
incorporated by reference.



2







Sales and marketing rights for Phentermine
37.5mg are included in the licensing agreement between the Company and Precision Dose Inc. (“Precision Dose”) dated
September 10, 2010 (the “Precision Dose License Agreement”). Please see the section below titled “Precision Dose
License Agreement” for further details of this agreement.



The first shipment of Phentermine 37.5mg was
made to Precision Dose’s wholly owned subsidiary, TAGI Pharmaceuticals Inc. (“TAGI”), pursuant to the Precision
Dose License Agreement, with such initial shipment triggering a milestone payment under this agreement. Phentermine 37.5mg is currently
being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.



Lodrane D® Immediate Release capsules

On September 27, 2011, the Company, along with
ECR Pharmaceuticals (“ECR”), launched Lodrane D®, an immediate release formulation of brompheniramine maleate and
pseudoephedrine HCl, an effective, low-sedating antihistamine combined with a decongestant.



ECR products have since been divested so that
Lodrane D® is promoted and distributed in the U.S. now by Valeant Pharmaceuticals International Inc. Lodrane D® is available
over-the-counter but also has physician promotion. Lodrane D® is one of the only adult brompheniramine containing products
available to the consumer at this time.



Lodrane D® is marketed under the Over-the-Counter
Monograph (the “OTC Monograph”) and accordingly, under the Code of Federal Regulations can be lawfully marketed in
the US without prior approval. Under the Federal Food Drug and Cosmetic Act (“FDCA”), FDA regulations and statements
of FDA policy, certain drug products are permitted to be marketed in the U.S. without prior approval. Within the past few years,
the FDA has revised its enforcement policies, significantly limiting the circumstances under which these unapproved products may
be marketed. If the FDA determines that a company is distributing an unapproved product that requires approval, the FDA may take
enforcement action in a variety of ways, including, without limitation, product seizures and seeking a judicial injunction against
distribution.



There have been several mergers relating to
ECR and successor entities and transfer of brand name ownership since this product was originally launched. Lodrane D® is accordingly
currently promoted and distributed in the U.S. by Valeant Pharmaceuticals International Inc. (“Valeant”). Lodrane D®
is available over-the-counter but also has physician promotion. Lodrane D® is the one of the only adult brompheniramine containing
products available to the consumer at this time.



Elite is manufacturing the product for Valeant
and will receive revenues for the manufacturing, packaging and laboratory stability study services for the product, as well as
royalties on sales.



Methadone 10mg tablets

Methadone 10mg is contract manufactured by
Elite for Ascend Laboratories, LLC (“Ascend”), the owner of the approved ANDA.



On January 17, 2012, Elite commenced shipping
Methadone 10mg tablets to Ascend pursuant to a commercial manufacturing and supply agreement dated June 23, 2011, as amended on
September 24, 2012 and January 19, 2015, between Elite and Ascend (the “Methadone Manufacturing and Supply Agreement”).
Under the terms of the Methadone Manufacturing and Supply Agreement, Elite performs manufacturing and packaging of Methadone 10mg
for Ascend.



Hydromorphone 8mg tablets

The approved ANDA for Hydromorphone 8mg was
acquired pursuant to an asset purchase agreement with Mikah Pharma LLC dated May 18, 2010 (the “Hydromorphone Purchase Agreement”).
Transfer of the manufacturing process of Hydromorphone 8mg to the Northvale Facility, a prerequisite of the Company’s commercial
launch of the product, was approved by the FDA on January 23, 2012.



3







Sales and marketing rights for Hydromorphone
8mg are included in the Precision Dose License Agreement. Please see the section below titled “Precision Dose License Agreement”
for further details of this agreement.



The first shipment of Hydromorphone 8mg was
made to TAGI, pursuant to the Precision Dose License Agreement, in March 2012, with such initial shipment triggering a milestone
payment under this agreement. Hydromorphone 8mg is currently being manufactured by Elite and distributed by TAGI under the Precision
Dose License Agreement.



Phendimetrazine Tartrate 35mg tablets

The ANDA for Phendimetrazine 35mg was acquired
by Elite as part of the asset purchase agreement between the Company and Mikah Pharma, dated August 1, 2013 (the “Mikah ANDA
Purchase”). Please see “Elite’s Acquisition of 13 Abbreviated New Drug Applications (“ANDAs”)”
below for more information on this agreement. The Northvale Facility was already an approved manufacturing site for this product
as of the date of the Mikah ANDA Purchase. Prior to the acquisition of this ANDA, Elite had been manufacturing this product on
a contract basis pursuant to a manufacturing and supply agreement with Mikah Pharma, dated June 1, 2011.



Phendimetrazine 35mg is currently a commercial
product being manufactured by Elite and distributed by Epic Pharma LLC (“Epic”) on a non-exclusive basis, and by Elite.



Phentermine 15mg and 30mg capsules

Phentermine 15mg capsules and Phentermine 30mg
capsules were developed by the Company, with Elite receiving approval of the related ANDA in September 2012.



Sales and marketing rights for Phentermine
15mg and Phentermine 30mg are included in the Precision Dose License Agreement. Please see the section below titled “Precision
Dose License Agreement” for further details of this agreement.



The first shipments of Phentermine 15mg and
Phentermine 30mg were made to TAGI, pursuant to the Precision Dose License Agreement, in April 2013, with such initial shipments
triggering a milestone payment under this agreement. Phentermine 15mg and Phentermine 30mg are currently being manufactured by
Elite and distributed by TAGI under the Precision Dose License Agreement.



Naltrexone 50mg

The approved ANDA for Naltrexone 50mg was acquired
by the Company pursuant to an asset purchase agreement between the Company and Mikah Pharma dated August 27, 2010 (the “Naltrexone
Acquisition Agreement”) for aggregate consideration of $200,000.



Sales and marketing rights for Hydromorphone
8mg are included in the Precision Dose License Agreement. Please see the section below titled “Precision Dose License Agreement”
for further details of this agreement.



The first shipment of Naltrexone 50mg was made
to TAGI, pursuant to the Precision Dose License Agreement, in September 2013, with such initial shipment triggering a milestone
payment under this agreement. Naltrexone 50mg is currently being manufactured by Elite and distributed by TAGI under the Precision
Dose License Agreement.



Isradipine 2.5mg and Isradipine 5mg

The approved ANDAs for Isradipine 2.5mg and
Isradipine 5mg were acquired by Elite as part of the Mikah ANDA Purchase



Sales and marketing rights for Isradipine 2.5mg
and Isradipine 5mg are included in the manufacturing and license agreement between the Company and Epic Pharma LLC, dated October
2, 2013 (the “Epic Manufacturing and License Agreement”). Please see the section below titled “Epic Manufacturing
and License Agreement” for further details of this agreement.



4







The first shipment of Isradipine 2.5mg and
Isradipine 5mg were made to Epic, pursuant to the Epic Manufacturing and License Agreement, in January 2015. Isradipine 2.5mg and
Isradipine 5mg are currently being manufactured by Elite and distributed by Epic under the Epic Manufacturing and License Agreement.



Hydroxyzine 10mg, Hydroxyzine 25mg and
Hydroxyzine 50mg

The approved ANDAs for Hydroxyzine 10mg, Hydroxyzine
25mg and Hydroxyzine 50mg were acquired by Elite as part of the Mikah ANDA Purchase.



Sales and marketing rights for Hydroxyzine
10mg, Hydroxyzine 25mg and Hydroxyzine 50mg are included in the Epic Manufacturing and License Agreement.



The first shipment of Hydroxyzine 10mg, Hydroxyzine
25mg and Hydroxyzine 50mg were made by Epic, pursuant to the Epic Manufacturing and License Agreement, in April 2015. Hydroxyzine
10mg, Hydroxyzine 25mg and Hydroxyzine 50mg are currently being manufactured and distributed by Epic under the Epic Manufacturing
and License Agreement.



Approved products not yet commercialized

The Company currently owns seven different
approved ANDA’s, all of which were acquired as part of the Mikah ANDA Purchase. Each of these approved ANDA’s require
manufacturing site transfers as a prerequisite to commencement of commercial manufacturing and distribution. The products are relating
to each of these approved ANDA’s are included in the Epic Manufacturing and License Agreement, with Elite granting ANDA specific,
exclusive or non-exclusive market rights (depending on the ANDA) to Epic. Commercial manufacturing of these products is expected
to be transferred to either Epic or the Northvale Facility, with the required supplements to be filed with FDA in the manner and
time frame that is economically beneficial to the Company.



Asset Acquisition Agreements



Elite’s Purchase of a Generic Phentermine
Product

On September 10, 2010, Elite, together with
its subsidiary, Elite Laboratories, Inc., executed a Purchase Agreement (the “Phentermine Purchase Agreement”) with
Epic Pharma, LLC (“Epic” ) for the purpose of acquiring from Epic an ANDA for a generic phentermine product (the “Phentermine
ANDA”), with such being filed with the FDA at the time the Phentermine Purchase Agreement was executed. On February 4, 2011,
the FDA approved the Phentermine ANDA. The acquisition of the Phentermine ANDA closed on March 31, 2011 and Elite paid the full
acquisition price of $450,000 from the purchase agreement with Epic Pharma.



This product is being marketed and distributed
by Precision Dose Inc (“Precision Dose”) and its wholly owned subsidiary, TAGI Pharma Inc. (“TAGI”) pursuant
to the Precision Dose License Agreement, a description of which is set forth below.



Elite’s Purchase of a Generic Hydromorphone
HCl Product

On May 18, 2010, Elite executed an asset purchase
agreement with Mikah Pharma LLC (“Mikah”) (the “Hydromorphone Purchase Agreement”). Pursuant to the Hydromorphone
Purchase Agreement, the Company acquired from Mikah an approved ANDA for Hydromorphone 8 mg for aggregate consideration of $225,000,
comprised of an initial payment of $150,000, which was made on May 18, 2010. A second payment of $75,000 was due to be paid to
Mikah on June 15, 2010, with the Company having the option to make this payment in cash or by issuing to Mikah 937,500 shares of
the Company’s Common Stock. The Company elected and did issue 937,500 shares of Common Stock during the quarter ended December
31, 2010, in full payment of the $75,000 due to Mikah pursuant to the asset purchase agreement dated May 18, 2010.



This product is currently being marketed and
distributed by Precision Dose and its wholly owned subsidiary, TAGI, pursuant to the Precision Dose License Agreement, a description
of which is set forth below.



5







Elite’s Purchase of a Generic Naltrexone
Product



On August 27, 2010, Elite executed an asset
purchase with Mikah (the “Naltrexone Acquisition Agreement”). Pursuant to the Naltrexone Acquisition Agreement, Elite
acquired from Mikah the ANDA number 75-274 (Naltrexone Hydrochloride Tablets USP, 50 mg), and all amendments thereto, that have
to date been filed with the FDA seeking authorization and approval to manufacture, package, ship and sell the products described
in this ANDA within the United States and its territories (including Puerto Rico) for aggregate consideration of $200,000. In lieu
of cash, Mikah agreed to accept from Elite product development services to be performed by Elite.



This product is currently being marketed and
distributed by Precision Dose and its wholly owned subsidiary, TAGI, pursuant to the Precision Dose License Agreement, a description
of which is set forth below.



Elite’s Acquisition of 13 Abbreviated
New Drug Applications

On August 1, 2013, Elite executed an asset
purchase agreement (the “Mikah ANDA Purchase”) with Mikah and acquired from Mikah a total of 13 ANDAs, consisting of
12 ANDAs approved by the FDA and one ANDA under active review with the FDA, and all amendments thereto (the “Mikah 13 ANDA
Acquisition”) for aggregate consideration of $10,000,000, payable pursuant to a secured convertible note due in August 2016.



Each of the products referenced in the 12 approved
ANDAs require manufacturing site approval with the FDA. Elite believes that the site transfers qualify for CBE 30 review, with
one exception, which would allow for the product manufacturing transfer on an expedited basis. However, Elite can give no assurances
that all will qualify for CBE 30 review, or on the timing of these transfers of manufacturing site, or on the approval by the FDA
of the transfers of manufacturing site.



As of the date filing of this Quarterly Report
on Form 10-Q, the following products included in the Mikah Purchase Agreement have successfully achieved manufacturing site transfers:

| | · | Phendimetrazine 35mg
| | - | --------------------

| | · | Isradipine 2.5mg and Isradipine 5mg
| | - | -----------------------------------

| | · | Hydroxyzine 10mg, Hydroxyzine 25mg and
Hydroxyzine 50mg
| | - | -------------------------------------------------------



Elite has executed a Manufacturing and License
Agreement with Epic Pharma dated October 2, 2013 (the “Epic Pharma Manufacturing and License Agreement”), relating
to the manufacturing, marketing and sale of these 12 ANDAs. Please see below for further details on the Epic Pharma Manufacturing
and License Agreement.



Licensing, Manufacturing and Development
Agreements



Sales and Distribution Licensing Agreement
with Epic for Abuse-Deterrent ELI-200

On June 4, 2015, Elite Pharmaceuticals Inc.
and its wholly-owned subsidiary Elite Laboratories, Inc. (collectively, “Elite”) executed an exclusive License Agreement
(the “Agreement”) with Epic Pharma LLC. (“Epic”), to market and sell in the United States, ELI-200, an
undisclosed opioid with sequestered naltrexone capsules, owned by Elite. Epic will have the exclusive right to market ELI-200 and
its various dosage forms as listed in Schedule A of the Agreement (the “Products”). Epic is responsible for all regulatory
and pharmacovigilance matters related to the products. Pursuant to the Agreement, Elite will receive reimbursement of product development
costs incurred, milestone payments and a license fee. The license fee will be computed as a percentage of net sales of the Products
as defined in the Agreement by Epic. Elite will manufacture the product for sale by Epic on a cost plus basis and both parties
agree to execute a separate Manufacturing and Supply Agreement. The license fee is payable quarterly for the term of the Agreement.
Epic shall pay to Elite certain milestone payments as defined by the Agreement and are due upon the filing of a New Drug Application
(“NDA”) with the U.S. Food and Drug Administration (“FDA”) and upon receipt of an approval letter for the
NDA from the FDA. Reimbursement of $5 million for product development costs incurred prior to the Agreement, was paid to the Company
in June 2015. The term of the License Agreement is five years and may be extended for an additional five years upon mutual agreement
of the parties. Elite can terminate the Agreement on 90 days’ written notice in the Event that Epic does not pay to Elite
certain minimum annual license fees over the initial five year term of the Agreement. Either party may terminate this Agreement
upon a material breach and failure to cure that breach by the other party within a specified period.



6







Manufacturing and License Agreement with
Epic Pharma LLC

On October 2, 2013, Elite executed the Epic
Pharma Manufacturing and License Agreement. This agreement granted Epic Pharma certain rights to manufacture, market and sell in
the United States and Puerto Rico the 12 approved ANDAs acquired by Elite pursuant to the Mikah Purchase Agreement. Of the 12 approved
ANDAs, Epic Pharma will have the exclusive right to market six products as listed in Schedule A of the Epic Pharma Manufacturing
and License Agreement, and a non-exclusive right to market six products as listed in Schedule D of the Epic Pharma Manufacturing
and License Agreement. Epic Pharma is responsible for all regulatory and pharmacovigilance matters related to the products and
for all costs related to the site transfer for all products. Pursuant to the Epic Pharma Manufacturing and License Agreement, Elite
will receive a license fee and milestone payments. The license fee will be computed as a percentage of the gross profit, as defined
in the Epic Pharma Manufacturing and License Agreement, earned by Epic Pharma a result of sales of the products. The manufacturing
cost used for the calculation of the license fee is a predetermined amount per unit plus the cost of the drug substance (API) and
the sales cost for the calculation is predetermined based on net sales. If Elite manufactures any product for sale by Epic Pharma,
then Epic Pharma shall pay to Elite that same predetermined manufacturing cost per unit plus the cost of the API. The license fee
is payable monthly for the term of the Epic Pharma Manufacturing and License Agreement. Epic Pharma shall pay to Elite certain
milestone payments as defined by the Epic Pharma Manufacturing and License Agreement. To date, milestones totaling $1,000,000 have
been earned and received in relation to the signing of the Epic Pharma Manufacturing and License Agreement and the filing and approval
by the FDA of supplements relating to the transfer of manufacturing site for Isradipine 2.5mg and Isradipine 5mg. The term of the
Epic Pharma Manufacturing and License Agreement is five years and may be extended for an additional five years upon mutual agreement
of the parties. Twelve months following the launch of a product covered by the Epic Pharma Manufacturing and License Agreement,
Elite may terminate the marketing rights for any product if the license fee paid by Epic Pharma falls below a designated amount
for a six month period of that product. Elite may also terminate the exclusive marketing rights if Epic Pharma is unable to meet
the annual unit volume forecast for a designated product group for any year, subject to the ability of Epic Pharma, during the
succeeding six month period, to achieve at least one-half of the prior year’s minimum annual unit forecast. The Epic Pharma
Manufacturing and License Agreement may be terminated by mutual agreement of Elite and Epic Pharma, as a result of a breach by
either party that is not cured within 60 days notice of the breach, or by Elite as a result of Epic Pharma becoming a party to
a bankruptcy, reorganization or other insolvency proceeding that continues for a period of 30 days or more.



Methadone Manufacturing and Supply Agreement

On June 23, 2011 and as amended on September
24, 2012 and January 19, 2015, Elite entered into an agreement to manufacture and supply Methadone 10mg to ThePharmaNetwork LLC
(the “Methadone Manufacturing and Supply Agreement”). ThePharmaNetworkLLC was subsequently acquired by Alkem Laboratories
Ltd (“Alkem”) and now goes by the name Ascend Laboratories LLC (“Ascend”) and is a wholly owned subsidiary
of Alkem.



Ascend in the owner of the approved ANDA for
Methadone 10mg, and the Northvale Facility is an approved manufacturing site for this ANDA. The Methadone Manufacturing and Supply
Agreement provides for the manufacture and packaging by the Company of Ascend’s methadone hydrochloride 10mg tablets.



The initial shipment of Methadone 10mg pursuant
to the Methadone Manufacturing and Supply Agreement occurred in January 2012.



Licensing Agreement with Precision Dose
Inc.

On September 10, 2010, Elite executed a License
Agreement with Precision Dose (the “Precision Dose License Agreement”) to market and distribute Phentermine 37.5mg,
Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional products that require approval from
the FDA, through its wholly-owned subsidiary, TAGI Pharma, Inc. in the United States, Puerto Rico and Canada (the “Precision
Dose License Agreement”). Phentermine 37.5mg was launched in April 2011. Hydromorphone 8mg was launched in March 2012. Phentermine
15mg and Phentermine 30mg were launched in April 2013. Naltrexone 50mg was launched in September 2013. Precision Dose will have
the exclusive right to market these products in the United States and Puerto Rico and a non-exclusive right to market the products
in Canada.



7







Pursuant to the Precision Dose License Agreement,
Elite will receive a license fee and milestone payments. The license fee will be computed as a percentage of the gross profit,
as defined in the Precision Dose License Agreement, earned by Precision Dose as a result of sales of the products. The license
fee is payable monthly for the term of the Precision Dose License Agreement. The milestone payments will be paid in six installments.
The first installment was paid upon execution of the License Agreement. The remaining installments are to be paid upon FDA approval
and initial shipment of the products to Precision Dose. The term of the License Agreement is 15 years and may be extended for 3
successive terms, each of 5 years. Please see Part II, Item 1, Legal Proceedings below for details of an arbitration proceeding
commenced by Precision Dose related to certain terms and conditions of the Precision Dose License Agreement.



Development agreement with Akorn Pharmaceuticals

On January 10, 2011, Elite and Hi-Tech Pharmacal
Co, Inc. (subsequently acquired by Akorn Pharmaceuticals), entered into an agreement for Elite to develop an intermediate product
for a generic version of a prescription product for Akorn Pharmaceuticals (“Akorn”). Under the terms of the agreement,
Elite will undertake a development program for an intermediate product that Akorn shall then incorporate into a final product.
Akorn or its designees, shall be responsible for the filing of the ANDA for the finished product and the ANDA will be filed under
the Akorn name. Upon approval of the ANDA, Elite will manufacture the intermediate product. Akorn will manufacture the final product
and will be responsible for the marketing and sales of the final product. Akorn will pay Elite milestone payments for the development
work. Upon commercialization, Elite will receive payment for the manufacturing of the intermediate product and a percentage of
the profits generated from the sale of the product.



Please note that there can be no assurances
that the development program will result in an intermediate product that can be incorporated into a final product. There can be
no assurances that an ANDA will be filed by Akorn or its designees or that any such ANDA filed will receive marketing approval
by the FDA. Furthermore, there can be no assurances of the commercialization of a final product containing the intermediate relating
to this agreement or that such commercialization will result in profits being generated from the sale of the product.



For further details, please refer to the Current
Report on Form 8-K filed with the SEC on January 10, 2011, such filing being herein incorporated by reference.



Products Under Development

Elite’s research and development activities
are primarily focused on developing its proprietary abuse deterrent technology and the development of a range of abuse deterrent
opioid products that utilize this technology.



Elite’s proprietary abuse-deterrent technology,
utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate capsule which contains an opioid
agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence.
When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist
releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or
dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the
euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for
abuse or misuse by recreational drug abusers.



The first product to utilize our abuse deterrent
technology, ELI-200, has successfully completed Phase III studies, and, subject to the risks described below, the Company believes
that it will be able to file a New Drug Application (“NDA”) with the FDA during this fiscal year. The Company believes
that, when this application is accepted by the FDA and subject to the risks described below, it will be granted expedited review
by the FDA, and accordingly believes that any such approval could be received during the fiscal year ended March 31, 2017.



8







The Company believes that the abuse deterrent
technology can be applied to and incorporated into a wide range of opioids used today for pain management and has, to date, identified
10 additional products for potential development. All of these products are at early stages of development, with research and development
activities mainly consisting of in-house process development and laboratory studies. Extensive efficacy and safety studies, similar
to those conducted for ELI-200 have not yet been conducted for these other products. As a result, costs incurred in relation to
the development of these 10 products have not been material.



Research and development costs were $6.6 million
for the six months ended September 30, 2015 and $14.8 million and $4.0 million for the fiscal years ended March 31, 2015 and 2014,
respectively, with such costs relating almost entirely to the development of ELI-200, the first product developed by Elite that
incorporates the technology.



On June 4, 2015, the Company entered into a
sales and distribution licensing agreement which included a payment of $5 million to Elite for prior research and development activities,
with such representing the first material net cash inflows being generated by ELI-200. The agreement also includes an additional
$10 million to be paid upon the filing with and approval by the FDA of the NDA, and license fees based on the commercial sales
achieved by ELI-200, once marketing authorization has been granted by the FDA. Please note, as further detailed below, there can
be no assurances of the Company filing an NDA and receiving marketing authorization for ELI-200, and accordingly, there can be
no assurances that the Company will earn and receive the additional $10 million or future license fees. If the Company does not
receive these payments or fees, it most likely will materially adversely affect our financial condition.



Please note that, while the FDA is required
to review applications within certain timeframes, during the review process, the FDA frequently requests that additional information
be submitted. The effect of such request and subsequent submission can significantly extend the time for the NDA review process.
Until an NDA is actually approved, there can be no assurances that the information requested and submitted will be considered adequate
by the FDA to justify approval. The packaging and labeling of our developed products are also subject to FDA regulation. Based
on the foregoing, it is impossible to anticipate the amount of time that will be needed to obtain FDA approval to market any product.
In addition, there can be no assurances of the Company filing the required application(s) with the FDA or of the FDA approving
such application(s) if filed, and the Company’s ability to successfully develop and commercialize products incorporating
its abuse deterrent technology is subject to a high level of risk as detailed in “Item 1A-Risk Factors-Risks Related to our
Business” of this Annual Report on Form 10-K filed with SEC on June 15, 2015.



Abuse-Deterrent and Sustained Release
Opioids

The abuse-deterrent opioid products utilize
our patented abuse-deterrent technology that is based on a pharmacological approach. These products are combinations of a narcotic
agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse of the drug.  Both,
agonist and antagonist, have been on the market for a number of years and sold separately in various dose strengths.  Elite
has filed INDs for two abuse resistant products under development and has tested products in various pharmacokinetic studies. Elite
expects to continue to develop multiple abuse resistant products. Products utilizing the pharmacological approach to deter abuse
such as Suboxone®, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda®, a product
marketed in the United States by Pfizer, Inc., have been approved by the FDA and are being marketed in the United States.



Elite has developed, and retains the rights
to these abuse resistant and sustained release opioid products.  Elite may license these products at a later date to
a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the
product.



9







Elite also developed controlled release technology
for oxycodone under a joint venture with Elan which terminated in 2002. According to the Elan Termination Agreement, Elite acquired
all proprietary, development and commercial rights for the worldwide markets for the products developed by the joint venture, including
the sustained release opioid products. Upon licensing or commercialization of an oral controlled release formulation of oxycodone
for the treatment of pain, Elite will pay a royalty to Elan pursuant to the Termination Agreement.  If Elite were to
sell the product itself, Elite will pay a 1% royalty to Elan based on the product’s net sales, and if Elite enters into an
agreement with another party to sell the product, Elite will pay a 9% royalty to Elan based on Elite’s net revenues from
this product. (Elite’s net product revenues would include license fees, royalties, manufacturing profits and milestones)
Elite is allowed to recoup all development costs including research, process development, analytical development, clinical development
and regulatory costs before payment of any royalties to Elan.



Patents

Since our incorporation, we have secured the
following patents, of which two have been assigned for a fee to another pharmaceutical company. Elite’s patents are:



|PATENT                                                  |  | EXPIRATION DATE
|------------------------------------------------------- |  | ---------------
|U.S. patent 5,837,284 (assigned to Celgene Corporation) |  | November 2018  
|U.S. patent 6,620,439                                   |  | October 2020   
|U.S. patent 6,635,284 (assigned to Celgene Corporation) |  | March 2018     
|U.S. patent 6,926,909                                   |  | April 2023     
|U.S. patent 8,182,836                                   |  | April 2024     
|U.S. patent 8,425,933                                   |  | April 2024     
|U.S. patent 8,703,186                                   |  | April 2024     
|Canadian patent 2,521,655                               |  | April 2024     
|Canadian patent 2,541,371                               |  | September 2024 
|U.S. patent 9,056,054                                   |  | June 2030      



We also have pending applications for two additional
U.S. patents and three foreign patents. We intend to apply for patents for other products in the future; however, there can be
no assurance that any of the pending applications or other applications which we may file will be granted. We have also filed corresponding
foreign applications for key patents.



Prior to the enactment in the United States
of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“GATT”), the exclusive
rights afforded by a U.S. Patent were for a period of 17 years measured from the date of grant. Under GATT, the term of any U.S.
Patent granted on an application filed subsequent to June 8, 1995 terminates 20 years from the date on which the patent application
was filed in the United States or the first priority date, whichever occurs first. Future patents granted on an application filed
before June 8, 1995, will have a term that terminates 20 years from such date, or 17 years from the date of grant, whichever date
is later.



Under the Drug Price Competition Act, a U.S.
product patent or use patent may be extended for up to five years under certain circumstances to compensate the patent holder for
the time required for FDA regulatory review of the product. Such benefits under the Drug Price Competition Act are available only
to the first approved use of the active ingredient in the drug product and may be applied only to one patent per drug product.
There can be no assurance that we will be able to take advantage of this law.



Also, different countries have different procedures
for obtaining patents, and patents issued by different countries provide different degrees of protection against the use of a patented
invention by others. There can be no assurance, therefore, that the issuance to us in one country of a patent covering an invention
will be followed by the issuance in other countries of patents covering the same invention, or that any judicial interpretation
of the validity, enforceability, or scope of the claims in a patent issued in one country will be similar to the judicial interpretation
given to a corresponding patent issued in another country. Furthermore, even if our patents are determined to be valid, enforceable,
and broad in scope, there can be no assurance that competitors will not be able to design around such patents and compete with
us using the resulting alternative technology.



10







We also rely upon unpatented proprietary and
trade secret technology that we seek to protect, in part, by confidentiality agreements with our collaborative partners, employees,
consultants, outside scientific collaborators, sponsored researchers, and other advisors. There can be no assurance that these
agreements provide meaningful protection or that they will not be breached, that we will have adequate remedies for any such breach,
or that our trade secrets, proprietary know-how, and technological advances will not otherwise become known to others. In addition,
there can be no assurance that, despite precautions taken by us, others have not and will not obtain access to our proprietary
technology.



Trademarks

We currently plan to license at least some
of our products to other entities in the marketing of pharmaceuticals, but may also sell products under our own brand name in which
case we may register trademarks for those products.



Critical Accounting Policies and Estimates

Management’s discussion
addresses our Consolidated Financial Statements, which have been prepared in accordance with accounting principles generally accepted
in the United States of America. The preparation of these financial statements requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of
financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management
evaluates its estimates and judgment, including those related to bad debts, intangible assets, income taxes, workers compensation,
and contingencies and litigation. Management bases its estimates and judgments on historical experience and on various other factors
that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.



Management believes the
following critical accounting policies, among others, affect its more significant judgments and estimates used in the preparation
of its Consolidated Financial Statements. Our most critical accounting policies include the recognition of revenue upon completion
of certain phases of projects under research and development contracts. We also assess a need for an allowance to reduce our deferred
tax assets to the amount that we believe is more likely than not to be realized. We assess the recoverability of inventory, long-lived
assets and intangible assets whenever events or changes in circumstances indicate that the carrying value of the asset may not
be recoverable. We assess our exposure to current commitments and contingencies. It should be noted that actual results may differ
from these estimates under different assumptions or conditions.



Results of Consolidated Operations

Three Months Ended September 30, 2015 Compared
to Three Months Ended September 30, 2014

Our revenues for the three
months ended September 30, 2015 were $2,696k, an increase of $1,440k or approximately 115% over revenues for the comparable period
of the prior year, and consisted of $2,553k in manufacturing fees and $143k in licensing fees. Revenues for the three months ended
September 30, 2014, consisted of $851k in manufacturing fees and $405k in licensing fees.



Manufacturing fees Increased
by $1,702k, or approximately 200%, mostly due to the continued growth of the Company’s generic product lines.



Licensing fees decreased
by $262k, or approximately 65%, with this decrease being due to no milestone earning. The milestone earning pursuant the Epic Agreement
and related to successful manufacturing site transfer of Isradipine 2.5mg and Isradipine 5mg was completed in March 2015.



11







Research and development
costs for the three months ended September 30, 2015 were $4,172k, an increase of $589k or approximately 16% from $3,583k of such
costs for the comparable period of the prior year. The increase was due to the timing of ongoing clinical trials related to the
development of Elite’s abuse deterrent opioid products.



General and administrative
expenses for the three months ended September 30, 2015, were $881k, an increase of $159k, or approximately 22% from $722k of general
and administrative expenses for the comparable period of the prior year. The increase was primarily due to increases in the general
cost of operation. Please note that these higher levels of overhead costs are expected to continue.



Depreciation and amortization
for the three months ended September 30, 2015 was $165k, a decrease of $112k, or approximately 41%, from $277k for the comparable
period of the prior year. The decrease was primarily due to a decrease in the overall basis of depreciable assets resulting from
the expiry of the economic life of equipment since June 2014. The expansion and upgrade of the Northvale Facility, which has required
significant investments in property, plant and equipment, has not yet been placed in service. Accordingly, depreciation expenses
relating to these investments have not yet been recorded. When commissioned, the investments relating to the expansion of the Northvale
Facility will result in increased depreciation expense.



Non-cash compensation through
the issuance of stock options and warrants for the three months ended September 30, 2015 was $81k, an increase of $28k, or approximately
51% from $53k for the comparable period of the prior year. The increase is due to the issuance of employee stock options subsequent
to the quarter ended June 30, 2014.



As a result of the foregoing,
our loss from operations for the three months ended September 30, 2015 was $4,017, compared to a loss from operations of $4,061k
for the three months ended September 30, 2014.



Other income/expenses for
the three months ended September 30, 2015 were a net expense of $2,086k, a decrease in other income of $8,224k from the net other
income of $10,330k for the comparable period of the prior year. The decrease in other income/expense was due to derivative income
relating to changes in the fair value of our outstanding warrants during the quarter ended September 30, 2015 totaling a loss of
$2,150k, as compared to a derivative income of $10,380k for the comparable period of the prior year. Please note that derivative
income/(expenses) are determined in large part by the change in fair value of the warrants outstanding.



As a result of the foregoing,
our net loss for the three months ended September 30, 2015 was $1,931k, compared to a net income of $6,248k for the comparable
period of the prior year.



Six Months Ended September 30, 2015 Compared
to Six Months Ended September 30, 2014

Our revenues for the six
months ended September 30, 2015 were $9,776k, an increase of $7,358k or approximately 304% over revenues for the comparable period
of the prior year, and consisted of $4,229k in manufacturing fees, $5,000k in product development licensing and $547k in licensing
fees. Revenues for the six months ended September 30, 2014, consisted of $1,800k in manufacturing fees, $613k in licensing fees
and $5k in lab fees.



Manufacturing fees Increased
by $2,429k, or approximately 135%, mostly due to the continued growth of the Company’s generic product lines.



Product development licensing
increased by $5,000k due to licensing fees, relating to product development activities and earned from the Epic Collaborative Agreement,
which was signed during the quarter ended June 30, 2015.



Licensing fees decreased
by $66k, or approximately 11%, with this decrease being due to the prior year revenues including milestones totaling $200k and
relating to the successful manufacturing site transfer of Isradipine 2.5mg and Isradipine 5mg, offset by increased profit splits
earned from product sales relating to the TAGI and Epic licensing agreements.



12







Research and development
costs for the six months ended September 30, 2015 were $6,614k, a decrease of $1,009k or approximately 13% from $7,623k of such
costs for the comparable period of the prior year. The decrease was due to the timing of ongoing clinical trials related to the
development of Elite’s abuse deterrent opioid products.



General and administrative
expenses for the six months ended September 30, 2015, were $1,561k, an increase of $231k, or approximately 17% from $1,330k of
general and administrative expenses for the comparable period of the prior year. The increase was primarily due to significant
increases in the hiring of additional staff to support regulatory compliance activities, additional costs incurred in relation
to insurance and employee benefits. Please note that these higher levels of overhead costs are expected to continue.



Depreciation and amortization
for the six months ended September 30, 2015 was $326k, a decrease of $145k, or approximately 31%, from $471k for the comparable
period of the prior year. The decrease was primarily due to a decrease in the overall basis of depreciable assets resulting from
the expiry of the economic life of equipment since June 2014. The expansion and upgrade of the Northvale Facility, which has required
significant investments in property, plant and equipment, has not yet been placed in service. Accordingly, depreciation expenses
relating to these investments have not yet been recorded. When commissioned, the investments relating to the expansion of the Northvale
Facility will result in increased depreciation expense.



Non-cash compensation through
the issuance of stock options and warrants for the six months ended September 30, 2015 was $171k, an increase of $94k, or approximately
122% from $77k for the comparable period of the prior year. The increase is due to the issuance of employee stock options subsequent
to the quarter ended June 30, 2014.



As a result of the foregoing,
our loss from operations for the six months ended September 30, 2015 was $1,507k, compared to a loss from operations of $8,493k
for the six months ended September 30, 2014.



Other income/expenses
for the six months ended September 30, 2015 were a net income of $8,439k, a decrease in other income of $4,208k from the net
other income of $12,647k for the comparable period of the prior year. The decrease in other income/expense was due to
derivative income relating to changes in the fair value of our outstanding warrants during the quarter ended September 30,
2015 totaling an income of $8,578k, as compared to a derivative income of $11,122k and the sale of investment totaling
$1,671k for the comparable period of the prior year. Please note that derivative income/(expenses) are determined in large
part by the change in fair value of the warrants outstanding.



As a result of the foregoing,
our net income for the six months ended September 30, 2015 was $6,932k, compared to a net income of $4,155k for the comparable
period of the prior year.



Material Changes in Financial
Condition

Our working capital (total
current assets less total current liabilities), increased to a surplus of $9.6 million as of September 30, 2015 from a working
capital surplus of $7.3 million as of March 31, 2015, primarily due to working capital generated by sales of common stock and proceeds
from warrant exercise totaling $5.1 million, both of which are accretive to working capital.



Net cash used by operations was
$1.6million for the six months ended September 30, 2015, primarily due to our net income from continuing operations of $6.9
million, offset by non-cash credits totaling $7.6 million, which included, without limitation, depreciation and amortization
charges of $0.33 million, net income credits from the change in fair value of derivative liabilities of $8.6 million. In
addition, net cash provided by operations was effected by changes in the balances of assets and liabilities, including,
without limitation, decrease in account receivables and prepaid expenses totaling $0.39 million, resulting in a net source of
cash, offset by cash used in operation increases inventories and decreases in account payables and other current liabilities
of $1.3 million, resulting in a net use of cash.



LIQUIDITY AND CAPITAL RESOURCES



Cash and Working Capital

As of September 30, 2015, the Company had cash
on hand of $9.0 million and a working capital surplus of $9.6million. The Company believes that such resources, combined with the
Company’s access to the remaining $24.0 million available pursuant to the $40 million equity line with Lincoln Park, and
approximately $0.6 million available under the Hakim Credit Line are sufficient to fund operations through the current operating
cycle. For the six months ended September 30, 2015, we had loss from operations totaling $1.5 million, net other income totaling
$8.4 million and a net income of $6.9 million. Please note that the Company’s other income/(expenses) are significantly influenced
by the change in fair value of the warrants outstanding.



13







The Company does not anticipate
being profitable for the fiscal year ending March 31, 2016, due in large part to its plans to conduct clinical development and
commercialization activities on a range of abuse deterrent opioid products, on an accelerated and simultaneous basis. Such activities
require the investment of significant amounts in clinical trials, safety and efficacy studies, bioequivalence studies, product
manufacturing, regulatory expertise and filings, as well as investments in manufacturing and lab equipment and software. In order
to finance these significant expenditures, the Company entered into two purchase agreements with Lincoln Park, with such agreements
providing the company with equity lines totaling $50 million. We believe this amount of financing, if received, is sufficient to
fund the commercialization of the abuse deterrent opioid products identified. Please see below for further details on the financing
transactions with Lincoln Park.



Lincoln Park Capital

On April 10, 2014, we entered
into a Purchase Agreement and a Registration Rights Agreement with Lincoln Park Capital (the “LPC 40 Purchase Agreement”).
Pursuant to the terms of the Purchase Agreement, Lincoln Park has agreed to purchase from us up to $40 million of our common stock
(subject to certain limitations) from time to time over a 36-month period. Pursuant to the terms of the Registration Rights Agreement,
we have filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been or
may be issued to Lincoln Park under the Purchase Agreement. That registration statement was declared effective by the SEC on May
1, 2014. A post-effective amendment to that Registration Statement was subsequently filed with the SEC and declared effective on
July 1, 2014.



Upon execution of the Purchase
Agreement, we have issued 1,928,641 shares of our common stock to Lincoln Park pursuant to the Purchase Agreement as consideration
for its commitment to purchase additional shares of our common stock under that agreement and we are obligated to issue up to an
additional 1,928,641 commitment shares to Lincoln Park pro rata as up to $40 million of our common stock is purchased by Lincoln
Park. Through November 9, 2015, we have sold to Lincoln Park an aggregate of 60.3 million shares under the Purchase Agreement for
aggregate gross proceeds of approximately $16.0 million. In addition, we have issued an additional 0.8 million Commitment Shares.



We may, from time to time
and at our sole discretion but no more frequently than every other business day, direct Lincoln Park to purchase (a “Regular
Purchase”) up to 500,000 shares of our common stock on any such business day, increasing up to 800,000 shares, depending
upon the closing sale price of the common stock, provided that in no event shall Lincoln Park purchase more than $760,000 worth
of our common stock on any single business day. The purchase price of shares of Common Stock related to the future Regular Purchase
funding will be based on the prevailing market prices of such shares at the time of sales (or over a period of up to 10 business
days leading up to such time), but in no event will shares be sold to Lincoln Park on a day the Common Stock closing price is less
than the floor price of $0.10 per share, subject to adjustment.



In addition to Regular Purchases,
on any business day on which we have properly submitted a Regular Purchase notice and the closing sale price is not below $0.15,
we may purchase (an “Accelerated Purchase”) an additional “accelerated amount” under certain circumstances.
The amount of any Accelerated Purchase cannot exceed the lesser of three times the number of purchase shares purchased pursuant
to the corresponding Regular Purchase; and 30% of the aggregate shares of our common stock traded during normal trading hours on
the purchase date. The purchase price per share for each such Accelerated Purchase will be equal to the lower of (i) 97% of the
volume weighted average price during the purchase date; or (ii) the closing sale price of our common stock on the purchase date.



In the case of both Regular
Purchases and Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization,
non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute
the purchase price.



14







Other than as set forth above,
there are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount
of any sales of our common stock to Lincoln Park.



Our sales of shares of Common
Stock to Lincoln Park under the Lincoln Park Purchase Agreement are limited to no more than the number of shares that would result
in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 9.99% of the then outstanding
shares of Common Stock.



The Lincoln Park Purchase
Agreement and the Lincoln Park Registration Rights Agreement contain customary representations, warranties, agreements and conditions
to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate
the Lincoln Park Purchase Agreement at any time, at no cost or penalty. Actual sales of shares of Common Stock to Lincoln Park
under the Lincoln Park Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time,
including, without limitation, market conditions, the trading price of the Common Stock and determinations by the Company as to
appropriate sources of funding for the Company and its operations. There are no trading volume requirements or restrictions under
the Lincoln Park Purchase Agreement. Lincoln Park has no right to require any sales by the Company, but is obligated to make purchases
from the Company as it directs in accordance with the Lincoln Park Purchase Agreement. Lincoln Park has covenanted not to cause
or engage in any manner whatsoever, any direct or indirect short selling or hedging of our shares.



The net proceeds under the
Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln
Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park under the Lincoln Park Purchase
Agreement will be used for general corporate purposes and working capital requirements.



The foregoing descriptions of the LPC 40 Purchase
Agreement, and the Registration Rights Agreement are qualified in their entirety by reference to the full text of the LPC 40 Purchase
Agreement, and the Registration Rights Agreement, copies of which are attached to the Current Report on Form 8-K, filed with the
SEC on April 14, 2014 as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference.
The representations, warranties and covenants contained in such agreements, were made only for purposes of such agreements and
as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon
by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with
execution of the agreements.



Hakim $1,000,000 Bridge Revolving Credit
Line

On October 15, 2013 (the “Hakim Credit
Line Effective Date”), and as amended on January 28, 2015, we entered into a bridge loan agreement (the “Hakim Loan
Agreement”) with Nasrat Hakim, our President and CEO. Under the terms of the Hakim Loan Agreement, we have the right, in
our sole discretion, to a line of credit (“Hakim Credit Line”) in the maximum principal amount of up to $1,000,000
at any one time. Mr. Hakim provided the Credit Line for the purpose of supporting the acceleration of our product development activities.
The outstanding amount will be evidenced by a promissory note which shall mature on March 31, 2016, at which time the entire unpaid
principal balance plus accrued interest thereon shall be due and payable in full. We may prepay any amounts owed without penalty.
Any such prepayments shall first be attributable to interest due and owing and then to principal. Interest only shall be payable
quarterly on January 1, April 1, July 1 and October 1 of each year. Prior to maturity or the occurrence of an Event of Default
as defined in the Hakim Loan Agreement, we may borrow, repay, and reborrow under the Hakim Credit Line through maturity. Amounts
borrowed under the Hakim Credit Line will bear interest at the rate of ten percent (10%) per annum. As of September 30, 2015, the
principal balance owed under the Credit Line was $411,709 with an additional $41,658 in accrued interest being also owed, in accordance
with the terms and conditions of the Credit Line. On January 28, 2015, The Development and License Agreement dated August 27, 2010
and between the Company and Mikah Pharma LLC (the “Mikah Development Agreement”) was terminated. Pursuant to the Mikah
Development Agreement, Mikah Pharma LLC (“Mikah”) made advance consideration payments to the Company totaling $200,000
in exchange for product development services to be provided at a future date. Subsequent to the execution of the Mikah Development
Agreement, and before any development milestones were achieved, the sole owner of Mikah, Mr. Nasrat Hakim, became the President
and Chief Executive Officer of the Company. Mikah has accordingly ceased operating and is in the process of winding down and liquidating
its assets. Any further development of the product related to this agreement will belong to the Company, although there can be
no assurances that such development will occur or be successful. The Mikah Development Agreement requires that the consideration
paid in advance to the Company be refunded in the event of no milestones being achieved. Mr. Hakim, as owner of Mikah, has directed
that the $200,000 refund due to Mikah not be paid currently, but rather be added to the amounts due under the Hakim Credit Line.



15







NJEDA Bonds

On August 31, 2005, the Company successfully
completed a refinancing of a prior 1999 bond issue through the issuance of new tax-exempt bonds (the “Bonds”). The
refinancing involved borrowing $4,155,000, evidenced by a 6.5% Series A Note in the principal amount of $3,660,000 maturing on
September 1, 2030 and a 9% Series B Note in the principal amount of $495,000 maturing on September 1, 2012. The net proceeds, after
payment of issuance costs, were used (i) to redeem the outstanding tax-exempt Bonds originally issued by the Authority on September
2, 1999, (ii) refinance other equipment financing and (iii) for the purchase of certain equipment to be used in the manufacture
of pharmaceutical products. As of September 30, 2015, all of the proceeds were utilized by the Company for such stated purposes.



Interest is payable semiannually on March 1
and September 1 of each year. The Bonds are collateralized by a first lien on the Company’s facility and equipment acquired
with the proceeds of the original and refinanced Bonds. The related Indenture requires the maintenance of a $415,500 Debt Service
Reserve Fund consisting of $366,000 from the Series A Notes proceeds and $49,500 from the Series B Notes proceeds. The Debt Service
Reserve is maintained in restricted cash accounts that are classified in Other Assets.



Bond issue costs of $354,000 were paid from
the bond proceeds and are being amortized over the life of the bonds. Amortization of bond issuance costs amounted to $7,089 for
the six months ended September 30, 2015.



The NJEDA Bonds require the Company to make
an annual principal payment on September 1st of varying amounts as specified in the loan documents and semi-annual interest payments
on March 1st and September 1st, equal to interest due on the outstanding principal at the applicable rate for the semi-annual period
just ended.



As of the date of filing of this Quarterly
Report on Form 10-Q, the Series B Note has been paid in full and retired and all principal and interest payments due and owing
under the Series A Note have been paid in full.



The Company has classified the principal amounts
with a maturity of not more than twelve months from September 30, 2015, totaling $220,000, as current liabilities. Principal amounts
with maturities in excess of twelve months from September 30, 2016, totaling $1,845,000 have been recorded as non-current liabilities.



Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet
arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that would be considered
material to investors.



Effects of Inflation

We are subject to price risks arising from
price fluctuations in the market prices of the products that we sell. Management does not believe that inflation risk is material
to our business or our consolidated financial position, results of operations, or cash flows.



ITEM 3.	 QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK



Market risk is the potential loss arising from
adverse changes in the financial markets, including interest rates and foreign currency exchange rates.



Interest rate risk

As of September 30, 2015, our principal debt
obligations included EDA bonds payable with a total principal balance of $2.065 million, loans payable with principal balances
totaling $0.743 million, and principal balances owed pursuant to related party lines of credit totaling $0.411 million. Interest
rates for all such indebtedness are fixed and accordingly there is no significant interest rate sensitivity related to these liabilities.



16







Foreign Currency Exchange Risk

We operate and transact business in US Dollars,
accordingly, the Company is not exposed to any significant foreign currency exchange risk.



ITEM 4.    CONTROLS AND PROCEDURES



Evaluation of Disclosure Controls and Procedures

The Company has established disclosure controls
and procedures that are designed to ensure that information required to be disclosed in reports filed or submitted under the Securities
Exchange Act of 1934 (“the Exchange Act”), (i) recorded, processed, summarized and reported within the time periods
specified in the SEC’s rules and forms, and (ii) accumulated and communicated to our management to allow for timely decisions
regarding disclosure. A controls system cannot provide absolute assurance, however, that the objectives of the controls system
are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within
a company have been detected.



Under the supervision and with the participation
of our management, including the Chief Executive and Chief Financial Officers, we evaluated the effectiveness of the design and
operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act as of the
end of the period covered by this Quarterly Report on Form 10-Q. Based upon that evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were
not effective so that the information required to be disclosed by us in reports filed under the Exchange Act is (i) recorded, processed,
summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) accumulated and communicated
to our management in order to allow for timely decisions regarding disclosure.



Changes in Internal Controls

There have been no changes in our internal
control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15 (f) under the Exchange Act) during the
three months ended September 30, 2015 that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.



PART II.  OTHER INFORMATION



ITEM 1.   LEGAL PROCEEDINGS



In the ordinary course of business we may be
subject to litigation from time to time. Except as discussed below, there is no current, pending or, to our knowledge, threatened
litigation or administrative action to which we are a party or of which our property is the subject (including litigation or actions
involving our officers, directors, affiliates, or other key personnel, or holders of record or beneficially of more than 5% of
any class of our voting securities, or any associate of any such party) which in our opinion has, or is expected to have, a material
adverse effect upon our business, prospects financial condition or operations.



Arbitration with Precision Dose, Inc.

On May 9, 2014, Precision Dose Inc., the parent
company of TAGI Pharmaceuticals, Inc., commenced an arbitration against the Company alleging that the Company failed to properly
supply, price and satisfy gross profit minimums regarding Phentermine 37.5mg tablets, as required by the parties’ agreements.
Elite denies Precision Dose’s allegations and has counterclaimed that Precision Dose is no longer entitled to exclusivity
rights with respect to Phentermine 37.5mg tablets, and is responsible for certain costs, expenses, price increases and lost profits
relating to Phentermine 37.5mg tablets and the parties’ agreements. As of the date of filing of this current report on Form
10-Q the parties have reached agreement in settlement of these issues, with Precision Dose agreeing to pay certain amounts to the
Company in exchange for Elite agreeing to restore exclusivity rights with respect to Phentermine 37.5mg tablets, subject to certain
defined conditions. The Company has notified the Arbitrator of this settlement and is awaiting the Arbitrators issuance of the
proceeding termination document.



17







ITEM 1A.    RISK FACTORS



There have been no material changes from the
Risk Factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2015.



ITEM 2.    UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.



During the six months ended September 30, 2015,
we issued 37,306,248 shares of Common Stock that were unregistered, consisting of 37,252,079 shares being issued pursuant to the
exercise of cash warrants and options, with proceeds received totaling $2,328,255 and 54,169 shares being issued in payment of
salaries as per related employment agreements, with such salaries paid totaling $12,500. We relied on the exemption provided by
Section 4(a)(2) of the Securities Act of 1933 to issue the common stock The securities were offered and sold without any form of
general solicitation or general advertising and the offerees made representations that they were accredited investors.



Subsequent to September 30, 2015 and up to
and including November 5, 2015 (the latest practicable date), we issued a total of 3 million shares of Common Stock that were unregistered,
with all such unregistered shares being issued pursuant to the Strategic Alliance Agreement between the Company and Epic Investments
LLC (“Epic Investments”) dated March 18, 2009, as amended on April 30, 2009, June 1, 2009, and July 28, 2009 (the “Epic
Strategic Alliance”), which for obligation, which require the issuance of 3 million shares of Common Stock to Epic Investments
upon their notification to the Company of the FDA’s approval of the ANDA filed by Epic Pharma LLC for immediate release oxycodone
tablets



ITEM 3.  DEFAULTS
UPON SENIOR SECURITIES



None.



ITEM 4.  Mine
Safety Disclosures.



Not applicable.



ITEM 5.  Other
Information



None.



Item 6.  Exhibits



The exhibits listed in the index below are
filed as part of this report.



|Exhibit
        No. |  | Description                                                                                                                                                                                                                                                                                           
|------------------- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|                    |  |                                                                                                                                                                                                                                                                                                       
|2.1                 |  | Agreement and Plan of Merger  between Elite Pharmaceuticals, Inc., a Delaware corporation (“Elite-Delaware”) and Elite Pharmaceuticals, Inc., a Nevada corporation (“Elite-Nevada”), incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K filed with the SEC on January 9, 2012.
|                    |  |                                                                                                                                                                                                                                                                                                       
|3.1(a)              |  | Articles of Incorporation of Elite-Nevada, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the SEC on January 9, 2012.                                                                                                                                          



18







|3.1(b) |  | Certificate of Incorporation of Elite-Delaware, together with all other amendments thereto, as filed with the Secretary of State of the State of Delaware, incorporated by reference to (a) Exhibit 4.1 to the Registration Statement on Form S-4 (Reg. No. 333-101686), filed with the SEC on December 6, 2002 (the “Form S-4”), (b) Exhibit 3.1 to the Company’s Current Report on Form 8-K dated July 28, 2004 and filed with the SEC on July 29, 2004, (c) Exhibit 3.1 to the Company’s Current Report on Form 8-K dated June 26, 2008 and filed with the SEC on July 2, 2008, and (d) Exhibit 3.1 to the Company’s Current Report on Form 8-K dated December 19, 2008 and filed with the SEC on December 23, 2008.*
|------ |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(c) |  | Certificate of Designations, Preferences and Rights of Series A Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 4.5 to the Current Report on Form 8-K dated October 6, 2004, and filed with the SEC on October 12, 2004.*                                                                                                                                                                                                                                                                                                                                                                                                                                   
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(d) |  | Certificate of Retirement with the Secretary of the State of the Delaware to retire 516,558 shares of the Series A Preferred Stock, as filed with the Secretary of State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated March 10, 2006, and filed with the SEC on March 14, 2006.*                                                                                                                                                                                                                                                                                                                                                                                       
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(e) |  | Certificate of Designations, Preferences and Rights of Series B 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated March 15, 2006, and filed with the SEC on March 16, 2006.*                                                                                                                                                                                                                                                                                                                                                                                                                       
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(f) |  | Amended Certificate of Designations of Preferences, Rights and Limitations of Series B 8% Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated April 24, 2007, and filed with the SEC on April 25, 2007.*                                                                                                                                                                                                                                                                                                                                                                                       
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(g) |  | Certificate of Designations, Preferences and Rights of Series C 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K dated April 24, 2007, and filed with the SEC on April 25, 2007.*                                                                                                                                                                                                                                                                                                                                                                                                                       
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(h) |  | Amended Certificate of Designations, Preferences and Rights of Series C 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated April 24, 2007, and filed with the SEC on April 25, 2007.*                                                                                                                                                                                                                                                                                                                                                                                                               
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(i) |  | Amended Certificate of Designations of Preferences, Rights and Limitations of Series B 8% Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated September 15, 2008, and filed with the SEC on September 16, 2008.*                                                                                                                                                                                                                                                                                                                                                                               
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(j) |  | Amended Certificate of Designations, Preferences and Rights of Series C 8% Convertible Preferred Stock, as filed with the Secretary of the State of Delaware, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K dated September 15, 2008, and filed with the SEC on September 16, 2008.*                                                                                                                                                                                                                                                                                                                                                                                                       
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(k) |  | Amended Certificate of Designations of Preferences, Rights and Limitations of Series D 8% Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.3 to the Current Report on Form 8-K dated September 15, 2008, and filed with the SEC on September 16, 2008.*                                                                                                                                                                                                                                                                                                                                                                               
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(l) |  | Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated June 1, 2009, and filed with the SEC on June 5, 2009.*                                                                                                                                                                                                                                                                                                                                                                                                       
|       |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|3.1(m) |  | Amended Certificate of Designations of the Series D 8% Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on June 29, 2010, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated June 24, 2010 and filed with the SEC on July 1, 2010.*                                                                                                                                                                                                                                                                                                                                                                                                             



19







|3.1(n) |  | Amended Certificate of Designations of the Series E Convertible Preferred Stock as filed with the Secretary of State of the State of Delaware on June 29, 2010, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K, dated June 24, 2010 and filed with the SEC on July 1, 2010.*
|------ |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|       |  |                                                                                                                                                                                                                                                                                                         
|3.1(o) |  | Certificate of Designations of the Series G Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on April 18, 2013, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013 .      
|       |  |                                                                                                                                                                                                                                                                                                         
|3.1(p) |  | Certificate of Designation of the Series H Junior Participating Preferred Stock, incorporated by reference to Exhibit 2 (contained in Exhibit 1) to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.                                                                     
|       |  |                                                                                                                                                                                                                                                                                                         
|3.1(q) |  | Certificate of Designations of the Series I Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on February 6, 2014, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC on February 7, 2014  
|       |  |                                                                                                                                                                                                                                                                                                         
|3.2(a) |  | Amended and Restated By-Laws of the Company, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K dated March 17, 2014 and filed with the SEC on March 18, 2014.                                                                                                                  
|       |  |                                                                                                                                                                                                                                                                                                         
|3.2(b) |  | By-Laws of Elite-Delaware, as amended, incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form SB-2 (Reg. No. 333-90633) made effective on February 28, 2000 (the “Form SB-2”).*                                                                                       
|       |  |                                                                                                                                                                                                                                                                                                         
|4.1    |  | Form of specimen certificate for Common Stock of the Company, incorporated by reference to Exhibit 4.1 to the Form SB-2.*                                                                                                                                                                               
|       |  |                                                                                                                                                                                                                                                                                                         
|4.2    |  | Form of specimen certificate for Series B 8% Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.*                                                                    
|       |  |                                                                                                                                                                                                                                                                                                         
|4.3    |  | Form of specimen certificate for Series C 8% Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.*                                                                    
|       |  |                                                                                                                                                                                                                                                                                                         
|4.4    |  | Form of Warrant to purchase shares of Common Stock issued to purchasers in the private placement which closed on March 15, 2006 (the “Series B Financing”), incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.* 
|       |  |                                                                                                                                                                                                                                                                                                         
|4.5    |  | Form of Warrant to purchase shares of Common Stock issued to purchasers in the Series B Financing, incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.*                                                          
|       |  |                                                                                                                                                                                                                                                                                                         
|4.6    |  | Form of Warrant to purchase shares of Common Stock issued to the Placement Agent, in connection with the Series B Financing, incorporated by reference to Exhibit 4.4 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.*                                
|       |  |                                                                                                                                                                                                                                                                                                         
|4.7    |  | Form of Warrant to purchase 600,000 shares of Common Stock issued to Indigo Ventures, LLC, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated July 12, 2006 and filed with the SEC on July 18, 2006.*                                                                    



20







|4.8  |  | Form of Warrant to purchase up to 478,698 shares of Common Stock issued to VGS  PHARMA,  LLC, incorporated by reference as Exhibit 3(a) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.*                                                                                                                                  
|---- |  | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.9  |  | Form of Non-Qualified Stock Option Agreement for 1,750,000 shares of Common Stock granted to Veerappan Subramanian, incorporated by reference as Exhibit 3(b) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.*                                                                                                            
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.10 |  | Form of Warrant to purchase shares of Common Stock issued to purchasers in the private placement which closed on April 24, 2007 (the “Series C Financing”), incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.*                                                                          
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.11 |  | Form of Warrant to purchase shares of Common Stock issued to the placement agent in the Series C Financing, incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.*                                                                                                                          
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.12 |  | Form of specimen certificate for Series D 8% Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.*                                                                                                                                     
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.13 |  | Form of Warrant to purchase shares of Common Stock issued to purchasers in the private placement which closed on September 15, 2008 (the “Series D Financing”), incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.*                                                              
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.14 |  | Form of Warrant to purchase shares of Common Stock issued to the placement agent in the Series D Financing, incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.*                                                                                                                  
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.15 |  | Form of specimen certificate for Series E Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated June 1, 2009, and filed with the SEC on June 5, 2009.*                                                                                                                                                   
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.16 |  | Warrant to purchase shares of Common Stock issued to Epic Investments, LLC in the initial closing of the Strategic Alliance Agreement, dated as of March 18, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated June 1, 2009, and filed with the SEC on June 5, 2009.*
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.17 |  | Form of specimen certificate for Series G Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013.                                                                                                                                                 
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.18 |  | Form of specimen certificate for Series I Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC on February 7, 2014.                                                                                                                                             
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.19 |  | Rights Agreement, dated as of November 15, 2013, between the Company and American Stock Transfer & Trust Company, LLC., incorporated by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.                                                                                                                                
|     |  |                                                                                                                                                                                                                                                                                                                                                                                  
|4.20 |  | Form of Series H Preferred Stock Certificate, incorporated by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.                                                                                                                                                                                                          





21







|10.1  |  | Elite Pharmaceuticals, Inc. 2014 Equity Incentive Plan, incorporated by reference to Appendix B to the Company’s Definitive Proxy Statement for its Annual Meeting of Shareholders, filed with the SEC on April 3, 2014.                                                                                                                                                                                                                                                                                                   
|----- |  | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.2  |  | Form of Confidentiality Agreement (corporate), incorporated by reference to Exhibit 10.7 to the Form SB-2.                                                                                                                                                                                                                                                                                                                                                                                                                 
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.3  |  | Form of Confidentiality Agreement (employee), incorporated by reference to Exhibit 10.8 to the Form SB-2.                                                                                                                                                                                                                                                                                                                                                                                                                  
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.4  |  | Product Development and Commercialization Agreement, dated as of June 21, 2005, between the Company and IntelliPharmaceutics, Corp., incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K, dated June 21, 2005 and originally filed with the SEC on June 27, 2005, as amended on the Current Report on Form 8-K/A filed September 7, 2005, as further amended by the Current Report on Form 8-K/A filed December 7, 2005 (Confidential Treatment granted with respect to portions of the Agreement).
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.5  |  | Agreement, dated December 12, 2005, by and among the Company, Elite Labs, and IntelliPharmaCeutics Corp., incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K, dated December 12, 2005, and originally filed with the SEC on December 16, 2005, as amended by the Current Report on Form 8-K/A filed March 7, 2006 (Confidential Treatment granted with respect to portions of the Agreement).                                                                                                     
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.6  |  | Loan Agreement, dated as of August 15, 2005, between New Jersey Economic Development Authority (“NJEDA”) and the Company, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.                                                                                                                                                                                                                                                  
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.7  |  | Series A Note in the aggregate principal amount of $3,660,000.00 payable to the order of the NJEDA, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.                                                                                                                                                                                                                                                                        
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.8  |  | Series B Note in the aggregate principal amount of $495,000.00 payable to the order of the NJEDA, incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.                                                                                                                                                                                                                                                                          
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.9  |  | Mortgage from the Company to the NJEDA, incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.                                                                                                                                                                                                                                                                                                                                    
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.10 |  | Indenture between NJEDA and the Bank of New York as Trustee, dated as of August 15, 2005, incorporated by reference to Exhibit 10.5 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.                                                                                                                                                                                                                                                                                  
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.11 |  | Form of Securities Purchase Agreement, between the Registrant and the signatories thereto, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.                                                                                                                                                                                                                                                                                     
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.12 |  | Form of Registration Rights Agreement, between the Registrant and signatories thereto, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March 16, 2006.                                                                                                                                                                                                                                                                                         
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|10.13 |  | Form of Placement Agent Agreement, between the Registrant and Indigo Securities, LLC, incorporated by reference as Exhibit 10.3 to the Current Report on Form 8-K, dated March 15, 2006, and filed with the SEC on March 16, 2006.                                                                                                                                                                                                                                                                                         





22







|10.14 |  | Financial Advisory  Agreement  between  the  Registrant and Indigo Ventures LLC, incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K dated July 12, 2006 and filed with the SEC on July 18, 2006.                                                                                     
|----- |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                                                                                                                                                                                                                                               
|10.15 |  | Product Collaboration Agreement between the Registrant and ThePharmaNetwork LLC, incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K, dated November 10, 2006 and filed with the SEC on November 15, 2006. (Confidential Treatment granted with respect to portions of the Agreement).
|      |  |                                                                                                                                                                                                                                                                                                               
|10.16 |  | Strategic Alliance Agreement among the Registrant, VGS Pharma (“VGS”) and Veerappan S. Subramanian  (“VS”), incorporated by reference as Exhibit 10(a) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.                                                 
|      |  |                                                                                                                                                                                                                                                                                                               
|10.17 |  | Advisory Agreement, between the Registrant and VS, incorporated by reference as Exhibit 10(b) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.                                                                                                          
|      |  |                                                                                                                                                                                                                                                                                                               
|10.18 |  | Registration Rights Agreement between the Registrant, VGS and VS, incorporated by reference as Exhibit 10(c) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.                                                                                           
|      |  |                                                                                                                                                                                                                                                                                                               
|10.19 |  | Employment Agreement between Novel Laboratories Inc. (“Novel”) and VS, incorporated by reference as Exhibit 10(d) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.                                                                                      
|      |  |                                                                                                                                                                                                                                                                                                               
|10.20 |  | Stockholders’ Agreement between Registrant, VGS, VS and Novel, incorporated by reference as Exhibit 10(e) to the Current Report on Form 8-K, dated December 6, 2006 and filed with the SEC on December 12, 2006.                                                                                              
|      |  |                                                                                                                                                                                                                                                                                                               
|10.21 |  | Form of Securities Purchase Agreement, between the Registrant and the signatories thereto, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.                                                                        
|      |  |                                                                                                                                                                                                                                                                                                               
|10.22 |  | Form of Registration Rights Agreement, between the Registrant and the signatories thereto, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.                                                                        
|      |  |                                                                                                                                                                                                                                                                                                               
|10.23 |  | Form of Placement Agent Agreement, between the Company and Oppenheimer & Company, Inc., incorporated by reference as Exhibit 10.3 to the Current Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April 25, 2007.                                                                           
|      |  |                                                                                                                                                                                                                                                                                                               
|10.24 |  | Form of Securities Purchase Agreement, between the Registrant and the signatories thereto, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated July 17, 2007 and filed with the SEC on July 23, 2007.                                                                          
|      |  |                                                                                                                                                                                                                                                                                                               
|10.25 |  | Form of Registration Rights Agreement, between the Registrant and the signatories thereto, incorporated by reference as Exhibit 10.2 to the Current Report on Form 8-K, dated July 17, 2007 and filed with the SEC on July 23, 2007.                                                                          
|      |  |                                                                                                                                                                                                                                                                                                               
|10.26 |  | Consulting Agreement, dated as of July 27, 2007, between the Registrant and Willstar Consultants, Inc., incorporated by reference as Exhibit 10.1 to the Quarterly Report on Form 10-Q for the period ending September 30, 2007 and filed with the SEC on November 14, 2007.                                  
|      |  |                                                                                                                                                                                                                                                                                                               
|10.27 |  | Form of Securities Purchase Agreement, between the Company and the signatories thereto, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.                                                                   





23







|10.28 |  | Form of Placement Agent Agreement, between the Company, ROTH Capital Partners, LLC and Boenning & Scattergood, Inc., incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K, dated September 15, 2008 and filed with the SEC on September 16, 2008.                                      
|----- |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                                                                                                                                                                                                                                               
|10.29 |  | Separation Agreement and General Release of Claims, dated as of October 20, 2008, by and between the Company and Stuart Apfel, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated October 15, 2008 and filed with the SEC on October 21, 2008.                                
|      |  |                                                                                                                                                                                                                                                                                                               
|10.30 |  | Consulting Agreement, dated as of October 20, 2008, by and between the Company and Parallex Clinical Research, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated October 15, 2008 and filed with the SEC on October 21, 2008.                                                
|      |  |                                                                                                                                                                                                                                                                                                               
|10.31 |  | Separation Agreement and General Release of Claims, dated as of November 3, 2008, by and between the Company and Charan Behl, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated October 28, 2008 and filed with the SEC on November 3, 2008.                                 
|      |  |                                                                                                                                                                                                                                                                                                               
|10.32 |  | Consulting Agreement, dated as of November 3, 2008, by and between the Company and Charan Behl, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated October 28, 2008 and filed with the SEC on November 3, 2008.                                                               
|      |  |                                                                                                                                                                                                                                                                                                               
|10.33 |  | Separation Agreement and General Release of Claims, dated as of November 5, 2008, by and between the Company and Bernard J. Berk, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated November 6, 2008 and filed with the SEC on November 6, 2008.                             
|      |  |                                                                                                                                                                                                                                                                                                               
|10.34 |  | Compensation Agreement, dated as of December 1, 2008, by and between the Company and Jerry I. Treppel, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated December 1, 2008 and filed with the SEC on December 4, 2008.                                                        
|      |  |                                                                                                                                                                                                                                                                                                               
|10.35 |  | Strategic Alliance Agreement, dated as of March 18, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated March 18, 2009 and filed with the SEC on March 23, 2009.                                   
|      |  |                                                                                                                                                                                                                                                                                                               
|10.36 |  | Amendment to Strategic Alliance Agreement, dated as of April 30, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated April 30, 2009 and filed with the SEC on May 6, 2009.                         
|      |  |                                                                                                                                                                                                                                                                                                               
|10.37 |  | Second Amendment to Strategic Alliance Agreement, dated as of June 1, 2009, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated June 1, 2009, and filed with the SEC on June 5, 2009.                    
|      |  |                                                                                                                                                                                                                                                                                                               
|10.38 |  | Third Amendment to Strategic Alliance Agreement, dated as of Aug 18, 2009, by and among the Company, Epic Pharma LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q, for the period ending June 30, 2009 and filed with the SEC on August 19, 2009.
|      |  |                                                                                                                                                                                                                                                                                                               
|10.39 |  | Employment Agreement, dated as of November 13, 2009, by and between the Company and Chris Dick, , incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q, for the period ending September 30, 2009 and filed with the SEC on November 16, 2009.                                       
|      |  |                                                                                                                                                                                                                                                                                                               
|10.40 |  | Employment Agreement, dated as of November 13, 2009, by and between the Company and Carter J. Ward, incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q, for the period ending September 30, 2009 and filed with the SEC on November 16, 2009.                                     



24







|10.41 |  | Elite Pharmaceuticals Inc. 2009 Equity Incentive Plan, as adopted November 24, 2009, incorporated by reference to Exhibit 10.1 to the Registration Statement Under the Securities Act of 1933 on Form S-8, dated December 18, 2009 and filed with the SEC on December 22, 2009.                                                                                      
|----- |  | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.42 |  | Stipulation of Settlement and Release, dated as of June 25, 2010, by and among the Company, Midsummer Investment, Ltd., Bushido Capital Master Fund, LP, BCMF Trustees, LLC, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated June 25, 2010 and filed with the SEC on July 1, 2010     
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.43 |  | Amendment Agreement, dated as of June 25, 2010, by and among the Company, and the investors signatory thereto, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated June 25, 2010 and filed with the SEC on July 1, 2010                                                                                                               
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.44 |  | Amendment Agreement, dated as of June 2010, by and among the Company, Epic Pharma, LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K, dated June 25, 2010 and filed with the SEC on July 1, 2010                                                                                                            
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.45 |  | Asset Purchase Agreement dated as of May 18, 2010, by and among Mikah Pharma LLC and the Company, incorporated by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010.                                                                                               
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.46 |  | Asset Purchase Agreement, dated as of August 27, 2010, by and among Mikah Pharma LLC and the Company, incorporated by reference to Exhibit 10.5 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).                
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.47 |  | Master Development and License Agreement, dated as of August 27, 2010, by and among Mikah Pharma LLC and the Company incorporated by reference to Exhibit 10.6 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions of the Agreement). 
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.48 |  | Purchase Agreement, dated as of September 10, 2010, by and among Epic Pharma LLC and the Company, incorporated by reference to Exhibit 10.7 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).                    
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.49 |  | License Agreement, dated as of September 10, 2010, by and among Precision Dose Inc. and the Company, incorporated by reference to Exhibit 10.8 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).                 
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.50 |  | Manufacturing and Supply Agreement, dated as of September 10, 2010, by and among Precision Dose Inc. and the Company, incorporated by reference to Exhibit 10.9 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.51 |  | Product Development Agreement between the Company and Hi-Tech Pharmacal Co., Inc. dated as of January 4, 2011, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated January 4, 2011 and filed with the SEC on January 10, 2011 (Confidential Treatment granted with respect to portions of the Agreement).                             
|      |  |                                                                                                                                                                                                                                                                                                                                                                      
|10.52 |  | Settlement Agreement between the Company and ThePharmaNetwork, LLC, dated as of March 11, 2011, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated March 11, 2011 and filed with the SEC on March 17, 2011.                                                                                                                          



25







|10.53 |  | Manufacturing & Supply Agreement between the Company and Mikah Pharma LLC, dated as of June 1, 2011, incorporated by reference to Exhibit 10.70 to the Annual Report on Form 10-K, for the period ended March, 31, 2011 and filed with the SEC on June 29, 2011 (Confidential Treatment granted with respect to portions of the Agreement).                                    
|----- |  | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.54 |  | Manufacturing & Supply Agreement between the Company and ThePharmaNetwork, LLC, dated as of June 23, 2011, incorporated by reference to Exhibit 10.71 to the Annual Report on Form 10-K, for the period ended March, 31, 2011 and filed with the SEC on June 29, 2011 (Confidential Treatment granted with respect to portions of the Agreement).                              
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.55 |  | Amendment, dated as of November 1, 2011, to the Master Development and License Agreement, dated as of August 27, 2010, by and amount Mikah Pharma LLC and the Company (Confidential Treatment granted with respect to portions of the Agreement), incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q for three and nine months ended December 31, 2011.
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.56 |  | Settlement Agreement between the Company and ThePharmaNetwork, LLC, dated as of March 11, 2011, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated March 11, 2011 and filed with the SEC on March 17, 2011.                                                                                                                                    
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.57 |  | Securities Purchase Agreement with Socius dated December 30, 2011, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on January 5, 2012.                                                                                                                                                                                          
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.58 |  | Amendment to Agreement with Socius dated February 28, 2012, incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K/A filed with the SEC February 29, 2012.                                                                                                                                                                                                
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.59 |  | Manufacturing & Supply Agreement between the Company and Mikah Pharma LLC, dated as of June 1, 2011, incorporated by reference to Exhibit 10.70 to the Annual Report on Form 10-K, for the period ended March, 31, 2011 and filed with the SEC on June 29, 2011 (Confidential Treatment granted with respect to portions of the Agreement).                                    
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.60 |  | Amendment, dated as of November 1, 2011, to the Master Development and License Agreement, dated as of August 27, 2010, by and amount Mikah Pharma LLC and the Company (Confidential Treatment granted with respect to portions of the Agreement), incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q for three and nine months ended December 31, 2011.
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.61 |  | Treppel $500,000 Bridge Loan Agreement dated June 12, 2012, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on June 13, 2012.                                                                                                                                                                                                   
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.62 |  | December 5, 2012 amendment to the Treppel Bridge Loan Agreement incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on December 10, 2012.                                                                                                                                                                                           
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.63 |  | Development And License Agreement between the Company and a Hong Kong-based client dated March 16, 2012 incorporated by reference to Exhibit 10.77 to the Annual Report on Form 10-K filed with the SEC on June 29,2012 (Confidential Treatment granted with respect to portions of the Agreement).                                                                            
|      |  |                                                                                                                                                                                                                                                                                                                                                                                
|10.64 |  | Letter Agreement between the Company and ThePharmaNetwork LLC, dated September 21, 2012 incorporated by reference to Exhibit 10.6 to the Quarterly Report on Form 10-Q filed with the SEC on November 14,2012 (Confidential Treatment granted with respect to portions of the Agreement).                                                                                      



26







|10.65 |  | Purchase Agreement between the Company and Lincoln Park Capital LLC dated April 19, 2013 , incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013.                                                                                            
|----- |  | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.66 |  | Registration Rights Agreement between the Company and Lincoln Park Capital LLC dated April 19, 2013 , incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013.                                                                                 
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.67 |  | August 1, 2013 Employment Agreement with Nasrat Hakim, incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.                                                                                                                                
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.68 |  | August 1, 2013 Mikah LLC Asset Purchase Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.  (Confidential Treatment granted with respect to portions of the Agreement).                                                       
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.69 |  | Revised Schedule 1 to the August 1, 2013 Mikah LLC Asset Purchase Agreement (revised to remove confidential treatment with regard to one item set forth thereon) incorporated by reference to Exhibit 10.12 to the Quarterly Report on Form 10-Q for the period ending December 31, 2013, filed with the SEC on February 14, 2014.
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.70 |  | August 1, 2013 Secured Convertible Note from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.                                                                                                        
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.71 |  | August 1, 2013 Security Agreement from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.                                                                                                              
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.72 |  | Termination of June 2011, Manufacturing and Supply Agreement between Mikah Pharma LLC and the Company, incorporated by reference to Exhibit 10.15 of the Quarterly Report on Form 10-Q for the period ending December 31, 2014 and filed with the SEC on February 14, 2014.                                                       
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.73 |  | October 15, 2013 Hakim Credit Line Agreement, incorporated by reference to Exhibit 10.16 to the Quarterly Report on Form 10-Q for the period ended September 30, 2013.                                                                                                                                                            
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.74 |  | October 2, 2013 Manufacturing and Licensing Agreement with Epic Pharma LLC, incorporated by reference to Exhibit 10.17 to the Amended Quarterly Report on Form 10-Q/A for the period ended September 30, 2013 and filed with the SEC on April 25, 2014.  Confidential Treatment granted with respect to portions of the Agreement.
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.75 |  | August 19, 2013, Master Services Agreement with Camargo Pharmaceutical Services, LLC, incorporated by reference to Exhibit 10.18 to the Quarterly Report on Form 10-Q for the period ended September 30, 2013 and filed with the SEC on November 14, 2013                                                                         
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.76 |  | November 21, 2013 Unsecured Convertible Note from the Company to Jerry Treppel, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated November 26, 2013 and filed with the SEC on November 26, 2013.                                                                                                 
|      |  |                                                                                                                                                                                                                                                                                                                                   
|10.77 |  | February 7,2014 Amendment to Secured Convertible Note from the Company to Mikah, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated February 7, 2014 and filed with the SEC on February 7, 2014.                                                                                                  



27







|10.78 |  | February 7, 2014 Amendment to Secured Convertible Note from the Company to Jerry Treppel, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated February 7, 2014 and filed with the SEC on February 7, 2014.                                                                                                                                                                                                              
|----- |  | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|10.79 |  | Purchase Agreement between the Company and Lincoln Park Capital LLC dated April 10, 2014 , incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated April 10, 2014 and filed with the SEC on April 14, 2014.                                                                                                                                                                                                                 
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|10.80 |  | Registration Rights Agreement between the Company and Lincoln Park Capital LLC dated April 10, 2014 , incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated April 10, 2014 and filed with the SEC on April 14, 2014.                                                                                                                                                                                                      
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|10.81 |  | Employment Agreement with Dr. G. Kenneth Smith, dated October 20, 2014, incorporated by reference to Exhibit 10.82 to the Quarterly Report on Form 10-Q for the period ended September 30, 2014 and filed with the SEC on November 14, 2014.                                                                                                                                                                                                           
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|10.82 |  | January 19, 2015 Second Amendment to TPN-Elite Manufacturing and Supply Agreement dated June 23, 2011 and First Amendment to the TPN-Elite Manufacturing and Supply Agreement dated September 21, 2012, incorporated by reference to Exhibit 10.82 to the Quarterly Report on Form 10-Q for the period ended December 31, 2014, and filed with the SEC on February 17, 2015.  Confidential Treatment granted with respect to portions of the Agreement.
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|10.83 |  | January 28, 2015 First Amendment to the Loan Agreement between Nasrat Hakim and Elite Pharmaceuticals dated October 15, 2013, incorporated by reference to Exhibit 10.83 to the Quarterly Report on Form 10-Q for the period ended December 31, 2014 and filed with the SEC on February 17, 2015.                                                                                                                                                      
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|10.84 |  | January 28, 2015 Termination of Development and License Agreement for Mikah-001 between Elite Pharmaceuticals, Inc. and Mikah Pharma LLC and Transfer of Payment, incorporated by reference to Exhibit 10.84 to the Quarterly Report on Form 10-Q for the period ended December 31, 2014 and filed with the SEC on February 17, 2015 .                                                                                                                 
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|10.85 |  | June 4, 2015 License Agreement with Epic Pharma LLC, incorporated by reference to Exhibit 10.85 to the Annual Report on Form 10-K for the fiscal year ended March 31, 2015 and filed with the SEC on June 15, 2015. Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.   
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|31.1  |  | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002**                                                                                                                                                                                                                                                                                                                                                   
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|31.2  |  | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002**                                                                                                                                                                                                                                                                                                                                                   
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|32.1  |  | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**                                                                                                                                                                                                                                                                                                                                                   
|      |  |                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|32.2  |  | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**                                                                                                                                                                                                                                                                                                                                                   



28







|101 |  | The following materials from Elite Pharmaceuticals’ Quarterly Report on Form 10-Q, related to the unaudited financial statements as and for the three months ended September 30, 2015 and 2014, formatted in eXtensible Business Reporting Language (“XBRL”): (i) the Consolidated Statements of Income; (ii) the Consolidated Balance Sheets; (iii) the Consolidated Statements of Cash Flows; and (iv) Notes to Consolidated Financial Statements.***
|--- |  | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



* On January 5, 2011, the Company changed its domicile from Delaware
to Nevada. All corporate documents from Delaware have been superseded by Nevada corporate documents filed or incorporated by reference
herein. All outstanding Delaware securities certificates are now outstanding Nevada securities certificates.



** Filed herewith.



*** Filed previously in Form 10-Q dated November 9, 2015.



29







SIGNATURES



Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.



|                        | ELITE PHARMACEUTICALS, INC.                 
|----------------------- | --------------------------------------------
|                        |                                             
|Date: November 10, 2015 | /s/ Nasrat Hakim                            
|                        | Nasrat Hakim                                
|                        | Chief Executive Officer                     
|                        | (Principal Executive Officer)               
|                        |                                             
|Date: November 10, 2015 | /s/ Carter J. Ward                          
|                        | Carter J. Ward                              
|                        | Chief Financial Officer                     
|                        | (Principal Financial and Accounting Officer)



30