ANDAs: Impurities in Drug Products: Guidance for Industry

Issue Date: November 29, 2010
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final

ANDAs: Impurities in Drug Products: Guidance for Industry

This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting.

Download the Guidance Document

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