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FDA Guidance for Industry: ANDAs: Impurities in Drug Products

Origin/Publisher:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072861.pdf

Document Type:
Guidance for Industry
Content:
This guidance provides recommendations on what chemistry, manufacturing and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of degradation products in drug products.

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