Baxalta’s Singapore Biologic Facility Gains FDA Approval

Baxalta’s recombinant biologic manufacturing facility in Singapore has received U.S. FDA approval to produce ADVATE [Antihemophilic Factor (Recombinant)] bulk drug substance (BDS). The site was also approved by the European Medicines Agency back in January 2014 for the production of ADVATE.
 
The approval follows a successful filing and site audit with no observations, confirming quality standards set by the agency and Good Manufacturing Processes (GMP). Baxalta’s manufacturing strategy aims to enable 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.