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# Shire Seeks Approval for Flexbumin Manufacturing Facility
- URL: https://www.fdaweb.com/shire-seeks-approval-for-flexbumin-manufacturing-facility/
- Published: 2018-10-26T12:00:00.000Z
- Updated: 2026-09-15T00:40:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142683

Shire has filed a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin 25% \[albumin (human)\], which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. Shire received FDA approval for the Georgia facility to manufacture Gammagard Liquid \[immune globulin infusion (human)\] 10% solution in June. The company also plans to expand its plasma collection network in Georgia and throughout the U.S. through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma used in the manufacturing process for immunology products at the Georgia facility.