WuXi Biologics Drug Substance and Pharmaceutical Facilities Re-Approved by US FDA and EMA


WUXI, China, September 19, 2022 /CNW/ –WuXi Biologics (“WuXi Bio”) (2269.HK), a global leader in contract research, development and manufacturing (CRDMO), today announced that its two drug substance facilities (DS) and a Pharmaceutical (DP)) located in Wuxi City has received regulatory approvals from the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).

After successfully completing the online Pre-Approval Inspection (PAI), WuXi Biologics has received EMA GMP certificates for the commercial manufacture of two biologics developed by global customers at its MFG4, MFG5 and DP2 facilities. This is the first time that MFG5, the newest operational DS installation with a total capacity of 60,000 L, and DP2, the second DP installation for bottles, have been certified by the EMA, only 10 months after being released for GMP manufacturing. The US FDA has also approved MFG5 to manufacture an innovative product for a global customer.

dr. Chris ChenCEO of WuXi Biologicssaid, “We are proud that our additional DS and DP facilities have again been approved by the US FDA and EMA. This is a strong testament to the global quality standards to which we adhere. We will continue to establish our world-class quality system across all global sites to ensure biologics are manufactured to the highest quality so that we can continue to offer our partners a robust supply chain to benefit patients. of the whole world. »

These approvals are in addition to 25 previous certifications from more than 10 global regulatory authorities. So far, WuXi Biologics has 13 certified DS and DP facilities globally.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a global contract research, development and manufacturing organization (CRDMO) providing end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 10,000 skilled employees in China, United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide its customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. From June 30, 2022WuXi Biologics supports 534 integrated customer projects, including 14 in commercial manufacturing.

WuXi Biologics views environmental, social and governance (ESG) responsibilities as an integral part of our business philosophy and strategy, and we aim to become an ESG leader in the CRDMO biologics industry. Our facilities use next-generation biomanufacturing technologies and clean energy sources. We have also set up an ESG Committee led by our CEO to drive the overall ESG strategy and its implementation, reinforcing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

SOURCE WuXi Biologics

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