WuXi Biologics, a Wuxi-based global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, became the first biologics company in China to be approved by both the U.S. FDA (Food and Drug Administration) and EMA (European Medicines Agency).
The company 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 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 bio-manufacturer. Through it high-quality products and high production capacity, WuXi Biologics is providing its global bio-manufacturing partners with a robust supply chain network.
"This marks yet another great milestone for WuXi Biologics and lays a solid foundation for the company to significantly expand its 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 its global partners to accelerate and transform biologics development from concept to reality."
