FDA Concluded its First Inspection of Apicore’s API Manufacturing Plant in Vadodara, Gujarat, India
SOMERSET, N.J., Oct. 5, 2011 /PRNewswire/ — Apicore LLC announced today that in September the U.S. Food and Drug Administration (FDA) completed its first inspection of Apicore’s wholly owned subsidiary Apicore Pharmaceuticals Pvt Ltd located in Vadodara, Gujarat, India.
The successful outcome of the inspection is a significant milestone in the growth of company. The firm now possesses the rare flexibility to provide its customers with Active Pharmaceutical Ingredients (API) manufactured in FDA inspected plants located in both the United States and India.
The ability to manufacture API in the United States can improve supply chain reliability and security for Apicore’s U.S. based customers. The firm’s manufacturing plant in India creates a low cost option to supply larger volumes of API to a global healthcare market where cost containment is a priority for governments and private payers alike.
To date, customers have obtained approval to market three (3) generic drug products using APIs manufactured by Apicore. An additional eleven (11) Abbreviated New Drug Applications (ANDA) have been filed referencing Drug Master Files (DMF) for APIs manufactured by the company. Several of the ANDAs that are pending approval represent opportunities for Apicore’s customers to launch the first generic equivalent to a brand name drug.
Mr. Ambrose Stafford, Vice President, Sales & 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. We’re a small company with big ambitions. In a hypercompetitive market it’s our human capital that differentiates us. 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.”
SOURCE Apicore LLC