WuXi Biologics Receives EMA GMP CertificatesWuXi Biologics to be the first biologics company in China approved by both the U.S. FDA and EMA
WuXi Biologics to be the first biologics company in China approved by both the U.S. FDA and EMA
SHANGHAI and WUXI, March 20, 2019 – WuXi Biologics (“WuXi Bio”) (2269.HK), 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,” commented 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.”
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.