This milestone represents an important step in the continued development of Rezon Bio’s global manufacturing network and reflects the company’s focus on building robust, compliant and reliable capabilities to support biologic therapies for patients worldwide.
The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and reflects the maturity of the site’s quality systems, technical capabilities and operational readiness for commercial supply to the US market.
This approval is coming subsequent to previous EMA GMP certification and approval for commercial supply to European markets.
Such approval further strengthens Rezon Bio’s ability to support clients-in-need to supply EU and US territories and enhances its position as a reliable partner within the contract development and manufacturing organisation (CDMO) landscape.
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