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Shire Files Submission for U.S. FDA Approval to Manufacture FLEXBUMIN
Oct. 25, 2018 09:35AM PST
Biotech InvestingShire (LSE:SHP, NASDAQ:SHPG), the leading global biotechnology company focused on rare diseases, announced that it has filed its second submission to the United States Food and Drug Administration (FDA) for its new plasma manufacturing facility near Covington, Georgia. As quoted in the press release: This second submission is for the manufacturing of FLEXBUMIN 25% [Albumin …
Shire (LSE:SHP, NASDAQ:SHPG), the leading global biotechnology company focused on rare diseases, announced that it has filed its second submission to the United States Food and Drug Administration (FDA) for its new plasma manufacturing facility near Covington, Georgia.
As quoted in the press release:
This second submission is for the manufacturing of FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution, a treatment primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. The Georgia facility received its first FDA approval, to manufacture GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution.
“We are very pleased to file this second submission for our state-of-the-art manufacturing facility in Georgia, after the facility received FDA approval earlier this year,” said Matt Walker, Head of Technical Operations for Shire. “Expanding our capacity for manufacturing FLEXBUMIN will allow us to better meet the increasing global demand for plasma protein therapies and further supports our growing immunoglobulin and bio-therapeutics portfolio by enabling us to deliver these important treatments to our patients.”