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Absorption Systems Registers as U.S. Generic Facility

Anticipates FDA registration for Panama ops

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Absorption Systems has registered with the U.S. FDA as a generic drug facility under the Generic Drug User Fee Amendments of 2012 (GDUFA), which requires the company to be a Biopharmaceutics Classification System (BCS), bioequivalence (BE), and bioavailability (BA) testing facility. Additionally, the company’s Panama operation will be registered under GDUFA in the 2H13.   GDUFA authorizes the FDA to collect user fees from drug sponsors for marketing applications, NDAs for a branded drug, or ANDA...

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