FDA Guidance for Industry: ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
Title:
FDA Guidance for Industry: ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
Origin/Publisher:
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072866.pdf
Document Type:
Guidance for Industry
Content:
This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms