Baxalta Incorporated has announced that its recombinant biologic manufacturing facility in Singapore has received U.S. Food and Drug Administration (FDA) approval 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, 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.