76108 Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 

European customers, meets the 

standards established by the European 

Pharmacopeia, administered by the 

Directorate for the quality of Medicines 

(EDQM). In order to ensure that its 

product will meet European 

specifications, the company seeks to 

import morphine supplied by EDQM for 

use as reference standards. No other 

activity for these drug codes is 

authorized for this registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2020–26172 Filed 11–25–20; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–743] 

Bulk Manufacturer of Controlled 

Substances Application: Novitium 

Pharma LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Novitium Pharma LLC has 

applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplemental Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before January 26, 2021. Such 

persons may also file a written request 

for a hearing on the application on or 

before January 26, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on November 2, 2020, 

Novitium Pharma LLC, 70 Lake Drive, 

East Windsor, New Jersey 08520, 

applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substances: 

Controlled substance Drug 

code Schedule 

Levorphanol ..................... 9220 II 

The company plans to bulk 

manufacture the above-controlled 

substance to support production of the 

company’s Food and Drug 

Administration approved drug product. 

No other activity for this drug code is 

authorized for this registration. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2020–26171 Filed 11–25–20; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–746] 

Importer of Controlled Substances 

Application: Noramco Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Noramco Inc. has applied to 

be registered as an importer of basic 

class(es) of controlled substance(s). 

Refer to Supplemental Information 

listed below for further drug 

information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before December 28, 2020. Such 

persons may also file a written request 

for a hearing on the application on or 

before December 28, 2020. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing must 

be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All requests for a 

hearing should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on October 23, 2020, 

Noramco Inc., 500 Swedes Landing 

Road, Wilmington, Delaware, 19801– 

4417, applied to be registered as an 

importer of the following basic class(es) 

of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Marihuana ........................ 7360 I 

Tetrahydrocannabinols .... 7370 I 

Nabilone .......................... 7379 II 

Phenylacetone ................. 8501 II 

Opium, Raw ..................... 9600 II 

Poppy Straw Concentrate 9670 II 

Tapentadol ...................... 9780 II 

The company plans to import 

Phenylacetone (8501), and Poppy Straw 

Concentrate (9670) to bulk manufacture 

other controlled substances for 

distribution to its customers. The 

company plans to import an 

intermediate form of Tapentadol (9780) 

to bulk manufacture Tapentadol for 

distribution to its customers. In 

reference to drug codes 7360 

(Marihuana) and 7370 

(Tetrahydrocannabinols), the company 

plans to import a synthetic cannabidiol 

and a synthetic Tetrahydrocannabinol. 

No other activity for these drug codes is 

authorized for this registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2020–26174 Filed 11–25–20; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–742] 

Importer of Controlled Substances 

Application: Lyndra Therapeutics 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Lyndra Therapeutics has 

applied to be registered as an importer 

of basic class(es) of controlled 

substance(s). Refer to Supplemental 

Information listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 


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