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 t...