STgen Bios Songdo Plant Receives FDA Appr... > 경제기사 | economics

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.


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/ 알파경제 Kim Jisun Reporter