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 for a generic drug. In exchange, a time limit is imposed on the agency's review of each application. Absorption Systems will not be charged a facility fee under GDUFA, since it is not involved in manufacturing of final dosage forms, APIs or primary packaging.
Patrick Dentinger, president and chief executive officer of Absorption Systems, said, "The world is gradually realizing what a unique and reliable approach to accelerating product approval the BCS is. Whereas GDUFA is expected to reduce the backlog of generic reviews, the BCS eliminates unnecessary human testing and dramatically reduces both the time and cost of product approval."