ANDAs: Impurities in Drug Substances

Docket Number:: FDA-1998-D-0021
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance provides revised recommendations on what chemistry, manufacturing, and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting:

Original abbreviated new drug applications (ANDAs)
Drug master files (DMFs) including type II DMFs
ANDA supplements for changes in the synthesis or processing of a drug substance

The guidance also provides recommendations for establishing acceptance criteria for impurities in drug substances.

Submit Comments

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: FDA-1998-D-0021.

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ANDAs: Impurities in Drug Substances

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