Tag: API
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The ANDA Prioritization Pilot Is a Smart, Strategic Move to Rebuild U.S. Generic Drug Manufacturing Capacity
The Food and Drug Administration’s new ANDA Prioritization Pilot realigns regulatory incentives to reward onshore bioequivalence testing and U.S. manufacturing of finished dosage forms and active pharmaceutical ingredients (API), and it will strengthen supply‑chain resilience, lower inspection costs, and speed patient access to affordable generics. The policy leverages FDA review speed as a targeted market