Baxalta Singapore facility receives FDA approval

State-of-the-art biologics facility approved by FDA to manufacture bulk drug substance for ADVATE [Antihemophilic Factor (Recombinant)], Baxalta’s market leading treatment for hemophilia A.

The FDA’s approval comes after a successful filing and site audit with zero observations, confirming that the site complies with the highest quality standards set by the agency and Good Manufacturing Processes (GMP). 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.

“As an established leader in the global hemophilia community, the FDA approval of our Singapore manufacturing facility reinforces our commitment to expanding access to advanced high quality treatments for patients globally,” said John Furey, senior vice president and head of Global Operations, Baxalta.

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.