Takeda receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
Monday, March 18, 2019 12:00 AM
March 18, 2019

−     FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient

−     Takeda received its first FDA approval for the Georgia facility, to manufacture GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, in June 2018

−     This state-of the art facility supports continued growth of Takeda’s plasma-derived therapies portfolio and further strengthens our ability to deliver these complex therapies for patients 

Cambridge, Massachusetts, March 18, 2019 --- Takeda Pharmaceutical Company Limited [TSE: 4502 / NYSE: TAK], (“Takeda”) today announced that the United States Food and Drug Administration (FDA) has approved the company’s second submission for its new plasma manufacturing facility near Covington, Georgia for the production of FLEXBUMIN 25% [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). Albumin is not indicated as an intravenous nutrient. 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 & 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.”

“Following the acquisition of Shire, Takeda created a Business Unit dedicated to meeting the large and growing demand for plasma-derived products, essential for treating patients with a variety of rare, life-threatening, chronic and genetic diseases. Our strategic focus and increased investment in plasma innovation and our world-class plasma collection and production capabilities will enable us to expand our broad, differentiated portfolio of medicines and serve more patients. Our Georgia facility is a key part of these plans,” added Julie Kim, President of Plasma-Derived Therapies at Takeda.

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.