Wuxi, Jiangsu ProvinceSeptember 20, 2022/ PR Newswire /-Wuxi Biologics, 2269.HK (WuXi Biologics, 2269.HK), the world's leading contract research, development and production (CRDMO) company, announced today that its two biological drug solution plants and one preparation plant in Wuxi have been certified by the European Drug Administration (EMA) and the U.S. Food and Drug Administration (FDA) GMP.
This time, Wuxi Biologics's MFG4, MFG5 and DP2 successfully passed EMA's online pre-approval inspection (PAI) of the company's two products produced for two global customers, and obtained GMP certification. Among them, MFG5 and DP2 are Wuxi Biologics's newly put into production large-scale commercial production plant of raw liquid (with a total capacity of 60,000 liters) and the second commercial production plant of Xilin bottle aseptic preparation, both of which have passed EMA certification for the first time within 10 months of GMP release, which once again confirms "Wuxi Biologics speed" and "Wuxi Biologics quality". In addition, MFG5 has been approved by FDA of the United States to produce an innovative product for a global customer.
Dr. Chen Zhisheng, Chief Executive Officer of Wuxi Biologics, said: "We are proud that many of our biopharmaceutical original solution plants and preparation plants continue to receive US FDA and EU EMA GMP certification, which is also a strong proof of Wuxi Biologics's adherence to the international quality standard system. We will continue to improve and consolidate the global supply chain with a world-class quality system, deliver high-quality biopharmaceuticals to our partners, empower innovation and benefit the majority of patients."
Prior to this, Wuxi Biologics has successfully obtained 25 certifications from more than 10 drug regulatory agencies around the world. At present, the company has 13 biological drug raw liquid and preparation production plants certified by drug regulatory agencies worldwide.
About Wuxi Biologics
Wuxi Biologics (Stock Code: 2269.HK) is a leading global contract research, development and production (CRDMO) company. Through an open and integrated biopharmaceutical capability and technology enabling platform, the company provides a full range of end-to-end services to help partners discover, develop and produce biopharmaceuticals, and realize the whole process from concept to commercial production. accelerate the global process of biopharmaceutical research and development, reduce R & D costs and benefit patients.
Wuxi Biologics has more than 10000 employees in China, the United States, Ireland, Germany and Singapore. With the professional service team composed of these employees, as well as excellent technology and insight, the company provides customers with efficient and cost-effective biopharmaceutical solutions. By the end of June 2022, Wuxi Biologics had helped customers develop and produce as many as 534 comprehensive projects, including 14 commercial production projects.
Wuxi Biologics regards Environment, Society and Governance (ESG) as an important part of business development and entrepreneurial spirit, and is committed to becoming a global ESG leader in biopharmaceutical CRDMO, such as leading the industry in the application of greener new generation biopharmaceutical technologies and energy. The company has established an ESG committee led by the CEO to fully implement the ESG strategy and implement the commitment to sustainable development.
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