STGen Bio's Songdo Plant Secures FDA cGMP Approval, Expanding Global Reach
Key Insights
STGen Bio (search)'s Songdo Bio Plant received cGMP approval from the U.S. FDA for its drug substance and pre-filled syringe manufacturing facilities.
This FDA approval, following EMA certification, enables STGen Bio (search) to supply high-quality biopharmaceuticals to the U.S., Europe, and Japan.
The approval positions STGen Bio (search) to commercially produce Stelara biosimilar DMB-3115 (ustekinumab) for both the U.S. and European markets.
STGen Bio (search), a subsidiary of Dong-A Socio Holdings, has announced that its Songdo Bio Plant has received current Good Manufacturing Practice (cGMP) approval from the U.S. Food and Drug Administration (FDA). This approval encompasses the plant's facilities for manufacturing Drug Substances (DS) and Pre-Filled Syringes (PFS).
The FDA's decision, which followed an inspection in June, certifies that the Songdo Bio Plant meets stringent U.S. manufacturing standards. This milestone closely follows the plant's attainment of EU-GMP certification from the European Medicines Agency (EMA) last month, marking a significant step in STGen Bio (search)'s global expansion.
Implications for Biopharmaceutical Production
With both FDA and EMA approvals secured, STGen Bio (search) is now positioned to produce commercial quantities of its Stelara biosimilar, DMB-3115 (ustekinumab), for distribution in the United States and Europe. Stelara is a medication used in the treatment of autoimmune diseases.
"With these EMA and FDA cGMP approvals, we have secured a global track record and laid the foundation for a global production base that can stably supply high-quality biopharmaceuticals to the three largest markets for biopharmaceuticals -- the United States, Europe and Japan," said Choi Kyung-eun, president of STGen Bio (search).
Strategic Advantages and Future Prospects
STGen Bio (search)'s ability to meet the rigorous demands of global regulatory bodies underscores its commitment to quality and its potential as a contract manufacturing organization (CMO). The company anticipates a surge in inquiries from global pharmaceutical companies seeking reliable manufacturing partners.
"We expect to receive more inquiries from global multinational pharmaceutical giants as we have proved our differentiated competitiveness in producing commercial products as a quality management-based contract manufacturing organization (CMO) company," added Choi Kyung-eun.