Baxalta Gets FDA Nod for Singapore Manufacturing Facility
Baxalta Incorporated, a biopharmaceutical company, has received approval from the US Food and Drug Administration for its recombinant biologic manufacturing facility in Singaporel to produce Advate [antihemophilic factor (recombinant)] bulk drug substance (BDS). The site received regulatory approval from the European Medicines Agency in January 2014 for the production of Advate.
The FDA's approval comes after a successful filing and site audit with zero observations. This approval is a key milestone in Baxalta's manufacturing strategy, enabling continued growth of the global Factor VIII portfolio, including Advate and additional investigational treatments, identical in each Baxalta manufacturing facility in which it is produced.
Baxalta's Singapore facility has been processing and supplying Advate to the European Union, Iceland, and Norway since it received its regulatory approval from the European Medicines Agency.
Advate [antihemophilic factor (recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.