Policy & Regulation
WuXi Biologics' two Wuxi city Drug Substance facilities and a Drug Product facility receive EMA and FDA regulatory approvals
20 September 2022 -

WuXi Biologics (2269.HK), a China-based global Contract Research, Development and Manufacturing Organisation (CRDMO), announced on Monday that it has received regulatory approvals from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city.

After passing online Pre-Approval Inspection (PAI), WuXi Biologics received EMA GMP certificates for the commercial manufacturing of two biologics developed by global clients at its MFG4, MFG5 and DP2 facilities. This is the first time MFG5, the newest operational DS facility with a total of 60,000L capacity, and DP2, the second DP facility for vials, have been certified by the EMA, only 10 months after they were released for GMP manufacturing. The US FDA also approved MFG5 to manufacture an innovative product for a global client.

Dr Chris Chen, WuXi Biologics CEO, said, 'We're proud that our additional DS and DP facilities have again been approved by both the U.S. FDA and EMA. It is a strong testament of the global quality standards we adhere to. We'll continue to establish our world-class quality system across all global sites to ensure that biologics are manufactured at the highest quality so that we can continue to enable our partners with a robust supply chain for the benefits of patients worldwide.'