Shire files for FDA approval for Covington plant

COVINGTON – Shire, the global biotechnology leader in rare diseases, on Wednesday announced that it has filed its first submission to the U.S. Food and Drug Administration for the company’s new plasma manufacturing facility in Covington. The plant, located in Stanton Springs in eastern Newton County, is expected to add approximately 30 percent capacity to the company’s internal network once fully operational. Commercial production is expected to begin in 2018.

The first FDA submission is for the transfer of Gammargard Liquid, a replacement therapy for primary humoral immunodeficiency. The company expects to make a second submission to the FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

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