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GUIDANCE DOCUMENT

Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs Guidance for Industry December 2000

Final
Docket Number:
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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