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FDA Completes Inspection of Apicore Site in India

Vadodara site can now provide API manufacturing

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Apicore LLC has completed its first inspection by the FDA of its subsidiary Apicore Pharmaceuticals Pvt Ltd., in Vadodara, Gujarat, India. The successful inspection allows the company to provide its customers with APIs manufactured in FDA inspected plants located in both the U.S. and India.   To date, customers have obtained approval to market three generic drug products using APIs manufactured by Apicore. An additional 11 ANDAs have been filed referencing Drug Master Files (DMF) for APIs manuf...

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