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Absorption Systems Registers with FDA as a Generic Drug Facility under GDUFA
Date:3/25/2013

generic drug applications, their growing complexity, and the need to inspect the growing number of generic drug facilities located overseas.

Absorption Systems' activities related to GDUFA involve classification of drug active ingredients according to the BCS. Part of the FDA drug approval pathway since 2000, the BCS classifies drugs according to the solubility and permeability of their active pharmaceutical ingredients (APIs). Absorption Systems is the world leader in the measurement of drug permeability for BCS classification. Drugs that meet the criteria for BCS Class I (high permeability and solubility) are eligible for a biowaiver, which simplifies the process of drug development.

Patrick Dentinger, President and CEO of Absorption Systems, commented that "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."

Collectively, these steps will benefit BCS adopters in the US and around the globe. The interest and growth in BCS applications have regulatory agencies around the world taking notice. With that in mind, Absorption Systems
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