WuXi Biologics 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," said Dr. Chris Chen, CEO of WuXi Biologics. "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."