Baxalta Gets FDA Approval for State-of-the-Art Singapore Facility

Baxalta announced that its state-of-the-art recombinant biologic manufacturing facility in Singapore received U.S. FDA approval to manufacture bulk drug substance for Advate, Baxalta’s market leading treatment for hemophilia A.

Nov. 17, 2015

Baxalta, a Baxter International spin off formed in July, announced that its state-of-the-art recombinant biologic manufacturing facility in Singapore received U.S. FDA approval to manufacture bulk drug substance for Advate, Baxalta’s market leading treatment for hemophilia A.

The approval comes after a successful filing and site audit with zero observations, confirming that the site complies with all Good Manufacturing Practices.

According to Baxalta, this site approval is a key milestone in the Illinois-based biopharmaceutical company's manufacturing strategy, enabling continued growth of its global Factor VIII portfolio, including Advate and additional investigational treatments.

Read the Baxalta press release