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FDA Completes Inspection of Apicore Site in India

October 6, 2011

Vadodara site can now provide API manufacturing

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 manufactured by the company.

Mr. Ambrose Stafford, vice president, sales and marketing said, "I feel great pride working with customers and the Apicore team to bring generic pharmaceutical products to market. Partnering with our customers, we're creating access to affordable drugs for patients and a return on investment for our customers and investors. The successful outcome of the FDA's first inspection of our plant in Vadodara, the fifth inspection of our plants in total, is an illustration of our organization's commitment to quality in everything that we do."

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