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          Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs
					Guidance for Industry
		
		December 2000


	Download the  Final Guidance Document 

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		    None found
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance is intended to describe the Office of Generic Drugs' (OGD) policy on the use of alternate sources of the active pharmaceutical ingredients (API) in unapproved abbreviated new drug applications (ANDAs). The guidance describes the circumstances under which an alternate source can be used. This guidance is intended to decrease the regulatory burden on industry and provide a more consistent approach to pre- and postapproval changes in API sources.


 
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						All written comments should be identified with this document's docket number: None found.

                                                                                  Content current as of:
      04/21/2020
         
                  
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