Reformulation may seem like an uphill climb. However, pharmaceutical developers can save significant time and expense by positioning a formulation change as only a chemistry, manufacturing, and controls (CMC) prior approval supplement (PAS) under the FDA’s scale-up and post-approval changes (SUPAC) guidance. Read this case study to find out how Recro Gainesville helped a client achieve a complex reformulation and successful CMC supplement filing in less than a year.

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Opioid Reformulation for Abuse Deterrence

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