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Shire Gets FDA Approval for Plasma Mfg. Facility

New facility will add 30% capacity to Shire's internal plasma manufacturing network once fully operational

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The U.S. Food and Drug Administration (FDA) has approved Shire’s first submission for its new plasma manufacturing facility near Covington, GA, for the production of Gammagard Liquid [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). The Covington facility will add approximately 30% capacity to Shire’s internal plasma manufacturing network once fully operational. Commercial production at the site began in January 2018,...

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