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(Source = Dong-A Socio Holdings homepage) |
[Alpha Biz= Reporter Kim Jisun] STgen Bio, a subsidiary of Dong-A Socio Holdings, announced on the 14th that it has received approval from the U.S. Food and Drug Administration (FDA) for its bio-production facility in Songdo, Incheon, in compliance with Current Good Manufacturing Practices (cGMP).
The approval covers the manufacturing facilities for drug substances (DS) and pre-filled syringes (PFS) at the Songdo plant. Prior to this approval, STgen Bio had already been producing four products at the facility.
In addition to the FDA approval, STgen Bio received Good Manufacturing Practice (GMP) approval from the European Medicines Agency (EMA) last month. The company is set to begin commercial production of the Stelara (ustekinumab) biosimilar, 'DMB-3115,' for distribution in the U.S. and Europe.
Alphabiz Reporter Kim Jisun(stockmk2020@alphabiz.co.kr)
