Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

Apicore LLC announced today that they filed a drug master file (DMF) for Fondaparinux Sodium active pharmaceutical ingredient (API) with the U.S. Food and Drug Administration (FDA) on June 28, 2010.

Since 2007, the company has partnered with a major generic pharmaceutical company to develop the API and prefilled syringes with the goal of obtaining approval for an ANDA to distribute a generic product equivalent to the brand name product Arixtra®.

Completion of the development, scale-up and validation of the company's manufacturing process and testing procedures for the API represents a significant milestone for Apicore and its partner on the path toward commercialization of a generic version of Arixtra®. The market for branded product in the United States was $266 million in the 12 months ended on March 31, 2010, an increase of 44% over the prior year, (as reported by IMS Health).

The company, established in 2005, develops and manufacturers APIs at its development laboratories and manufacturing sites located in Somerset, NJ, India and Vadodara, Gujarat, India for generic pharmaceutical customers worldwide

Mr. Ambrose Stafford, Vice President, Apicore LLC said, "We're very proud of the skill and dedication of our team who have worked tirelessly over several years to achieve this major milestone of completing the development of Fondaparinux Sodium API. With the same dedication and focus we look forward to continuing to work with our partner to complete the process of obtaining ANDA approval to distribute a generic version of Arixtra® pre-filled syringes, for which no generic option exists today."