Guidance for Industry on Drug Substance

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Guidance for Industry on Drug Substance
INTRODUCTION
Information on the chemistry, manufacturing, and controls (CMC) for the drug substance must be submitted to support the approval of original new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs).3 This guidance provides recommendations on the CMC information for drug substances that should be submitted to support these applications. The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.
This guidance addresses the information to be submitted for drug substances to ensure continued drug substance and drug product quality (i.e., the identity, strength, quality, purity, and potency).
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