19 March 2019 - - The United States Food and Drug Administration has approved Japanese drugmaker Takeda Pharmaceutical Company Ltd.'s (TOKYO: 4502) (NYSE: TAK) 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, and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn, the company said.

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.

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.

FLEXBUMIN 25% is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome, and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn.