STGen Bio Secures FDA cGMP Approval for Songdo Bio Plant

STGen Bio announced on the 14th that its Songdo Bio Plant has received current Good Manufacturing Practice (cGMP) approval from the U.S. Food and Drug Administration (FDA).

The approval covers the plant's facilities for manufacturing Drug Substances (DS) and Pre-Filled Syringes (PFS). STGen Bio explained that through continuous investment and facility upgrades, the plant successfully passed the FDA inspection conducted in June on the first attempt.

In addition to the FDA approval, the Songdo Bio Plant also obtained EU-GMP certification from the European Medicines Agency (EMA) last month. As a result, STGen Bio now operates a manufacturing facility that meets the requirements of two major global regulatory agencies.

Choi Kyung-eun, President of STGen Bio, stated, "With this approval, we are now positioned to reliably supply high-quality biopharmaceuticals to the three largest markets— the U.S., Europe, and Japan. We anticipate a surge in inquiries from global pharmaceutical companies regarding new projects."