First Biologic Company in China Approved by FDA and EMA

| By | GMP certificate, GMP Facilities, WuXi Biologics

WuXi Biologics, a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, announced that it has received EMA GMP certificates for the production of Trogarzo™ at its cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities in Wuxi city and its cGMP cell banking facilities in Shanghai. Trogarzo™ is developed by TaiMed Biologics and marketed in the U.S. and EU by Theratechnologies.

The certification further endorses WuXi Biologics’ premier-quality systems and solid reputation as a leading global biomanufacturing player. Through the world-class quality system and unparalleled capacities, WuXi Biologics is providing its global biomanufacturing partners with a robust and premier-quality supply chain network.

This marks yet another great milestone that WuXi Biologics has achieved and lays a solid foundation for us to significantly expand our manufacturing capacity and capabilities. With the recognition from both the U.S. FDA and EMA, WuXi Biologics will continue to enable our global partners to accelerate and transform biologics development from concept to commercialization,

commented Dr. Chris Chen, CEO of WuXi Biologics.

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