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FDA Guidance for Industry: ANDA's: Impurities in Drug Substances

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry
Content:
This guidance provides recommendations for information in ANDAs and supporting DMFs on the identification and qualification of impurities in drug subtances.

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