- Rezon Bio has received FDA approval for commercial biosimilar manufacturing at its Warsaw-Duchnice facility.
- The site previously obtained EMA GMP certification, enabling supply to both EU and US markets.
Rezon Bio has received approval from the U.S. Food and Drug Administration (FDA) for the commercial manufacturing of a biosimilar at its Warsaw-Duchnice facility. The approval enables commercial supply to the United States and follows earlier European Medicines Agency (EMA) GMP certification for supply to European markets.
The FDA approval follows a comprehensive review process and reflects the site’s quality systems, technical capabilities, and operational readiness. According to the company, the milestone strengthens its global manufacturing network and enhances its position within the CDMO and contract manufacturing landscape.
The Warsaw-Duchnice site operates as a biologics manufacturing and development center, offering integrated services from early development through commercial production. Capabilities include process and analytical development, GMP manufacturing, quality control, and regulatory affairs support.
“This milestone reflects the dedication of our teams to quality, collaboration, and scientific excellence. The FDA approval of our Warsaw-Duchnice site demonstrates our commitment to meeting applicable international quality and regulatory requirements and the ability to deliver reliable, world-class CDMO services.”
Adriana Kiędzierska-Mencfeld, CEO of Rezon Bio
Rezon Bio stated that the approval supports its ability to serve clients requiring supply to both EU and US territories and reinforces its commitment to compliant, cost-efficient biologics manufacturing for global partners.
