Winstgevend schreef op 27 december 2017 15:08:
Shire files for FDA approval of a new plasma manufacturing facility in Covington, Georgia to support growing Immunology franchise
Dublin, Ireland - December 27, 2017 - Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that it has filed its first submission to the United States Food and Drug Administration for the company`s new plasma manufacturing facility in Covington, Georgia. The facility is expected to add approximately 30% capacity to the company`s internal network once fully operational. Commercial production is expected to begin in 2018.
The first submission is for the transfer of GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). 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.
"We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018.