FDA nod for Flexbumin production at new plasma facility in Georgia

The US Food and Drug Administration has approved Japanese drug major Takeda Pharmaceutical’s (TYO: 4502) second submission for its new plasma manufacturing facility near Covington, Georgia for the production of Flexbumin L25% [albumin (human)], USP, 25% Solution, indicated for hypovolemia, hypoalbuminemia, (burns, adult respiratory distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).

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, adding: “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.”