Tag: FDA requirements
ANDA Process: Legal Requirements for Generic Drug Approval in the U.S.
The ANDA process is the legal pathway for generic drug approval in the U.S., requiring bioequivalence, identical active ingredients, and strict manufacturing standards under the Hatch-Waxman Act. Learn the key requirements, costs, and pitfalls.
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GMP for Generics: FDA Requirements for Manufacturing
Dec, 17 2025
