- WuXi Biologics received EMA GMP certification for four manufacturing facilities and a biosafety testing center in China.
WuXi Biologics (“WuXi Bio”) announced that four manufacturing facilities and the Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA).
The EMA issued GMP certificates following comprehensive inspections of WuXi Bio’s facilities: MFG1, MFG2, MFG5, and DP1 in Wuxi. These certificates validate the company’s capabilities for commercial and New Drug Application (NDA)-ready manufacturing services for eight biologics. The Suzhou Biosafety Testing Center also retained its certification, supporting ten novel therapies, including the biologics produced in Wuxi.
WuXi Biologics has a strong compliance record, completing 35 global regulatory inspections and over 1,250 GMP quality audits by global clients since 2017. The company now has 15 GMP-certified facilities in its global network.
Dr. Chris Chen, CEO of WuXi Biologics, stated, “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.”
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