Takeda Receives FDA Approval to Manufacture Flexbumin at Georgia Facility

In March, the U.S. Food and Drug Administration (FDA) approved Takeda Pharmaceuticals’ second submission for its new plasma manufacturing facility near Covington, Ga., for the production of Flexbumin 25% solution [albumin (human)], indicated for hypovolemia, hypoalbuminemia (burns, adult respiratory distress syndrome and nephrosis), cardiopulmonary bypass surgery and hemolytic disease of the newborn. The Georgia facility received its first FDA approval to manufacture Gammagard Liquid [immune globulin infusion (human)] 10% solution in June 2018.

“This latest approval is a significant milestone for the Georgia facility, Takeda and our patients,” said Thomas Wozniewski, global manufacturing and supply officer. “This new state-of-the-art facility is providing much needed additional capacity for meeting increasing global demand for plasma-derived therapies, and our team there will continue to scale up production over the coming years.” The Georgia facility currently employs more than 1,000 full-time and contract employees, and continues to hire to fill additional roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and various support and facility roles