WUXI and SUZHOU, China, Aug. 1, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that four manufacturing facilities and Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA), demonstrating the company's commitment to meeting rigorous international industry quality standards across its global network.

Following comprehensive inspections of the company's facilities– specifically MFG1, MFG2, MFG5, and DP1 in Wuxi– EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company's capabilities in providing such services for global clients. All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company's Suzhou Biosafety Testing Center was once again certified by the EMA to provide services for ten novel therapies, including the eight biologics being manufactured in Wuxi.

WuXi Biologics has a proven track record of strict quality compliance. Since 2017, the company has completed and passed 35 global regulatory agency inspections, more than 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons. Currently, WuXi Biologics has 15 GMP-certified drug substance and drug product facilities in its global network.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "We are proud that our facilities have once again been certified by the EMA, reflecting our unwavering commitment to the highest quality standards across the company. Quality audits are crucial to ensuring the safety and efficacy of the global pharmaceutical industry, and WuXi Biologics remains dedicated to enabling our clients in bringing high-quality biologics to patients worldwide."

https://en.prnasia.com/releases/global/wuxi-biologics-four-manufacturing-facilities-and-biosafety-testing-center-certified-again-by-european-medicines-agency-for-ten-biologics-456001.shtml