Apicore Files DMF For Fondaparinux Sodium With FDA

Apicore has partnered with a generic pharmaceutical company in 2007, to develop the API and prefilled syringes for getting approval on its ANDA to distribute a generic product equivalent to the brand name product Arixtra.

The completion of the development, scale-up and validation of the Apicore’s manufacturing process and testing procedures for the API represents a significant milestone for Apicore and its partner on the path toward commercialisation of a generic version of Arixtra.

Ambrose Stafford, vice president of Apicore, 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.”

Apicore, 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.