Shots:
- The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility
- The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market
- This approval follows earlier EMA GMP certification and authorization for commercial supply in European markets
Ref: Bussineswire | Image: Rezon Bio | Press Release
Related News: Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)
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