FDA Guidance on ANDA Drug Impurities

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Updated October 11, 2020

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ANDAs: Impurities in Drug Substances - an FDA webpage

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This guidance, FDA Guidance - ANDAs: Impurities in Drug Substances, 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: 1) Original abbreviated new drug applications (ANDAs), 2) Drug master files (DMFs) including type II DMFs, and 3) ANDA supplements for changes in the synthesis or processing of a drug substance.

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