China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced receiving its first GMP certificate from the Ireland Health Products Regulatory Authority (HPRA) for clinical-and commercial-stage product release testing in Dundalk, Ireland. This marks the first Manufacturer’s/Importation Authorization (MIA) and Investigational Medicinal Product (IMP) license for the company in Ireland.
Facility and Workforce
The site in Dundalk, which has been operational since March of this year, now employs more than 400 employees. This GMP certification underscores WuXi Biologics’ commitment to expanding its global footprint and enhancing its capabilities in clinical and commercial-stage product release testing.
Future Prospects and Strategic Implications
The receipt of the GMP certificate from the HPRA positions WuXi Biologics to further solidify its presence in the European market. By leveraging its state-of-the-art facilities and skilled workforce, WuXi Biologics aims to meet the growing demand for high-quality biologics and contribute to the advancement of global healthcare.-Fineline Info & Tech