WuXi Biologics' Drug Substance and Drug Product Facilities Again Approved by U.S. FDA and EMA

20 September 2022 | Tuesday | News

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received regulatory approvals from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Image Source : Public Domain

Image Source : Public Domain

After passing online Pre-Approval Inspection (PAI), WuXi Biologics received EMA GMP certificates for the commercial manufacturing of two biologics developed by global clients at its MFG4, MFG5 and DP2 facilities. This is the first time MFG5, the newest operational DS facility with a total of 60,000L capacity, and DP2, the second DP facility for vials, have been certified by the EMA, only 10 months after they were released for GMP manufacturing. The U.S. FDA also approved MFG5 to manufacture an innovative product for a global client.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We're proud that our additional DS and DP facilities have again been approved by both the U.S. FDA and EMA. It is a strong testament of the global quality standards we adhere to. We'll continue to establish our world-class quality system across all global sites to ensure that biologics are manufactured at the highest quality so that we can continue to enable our partners with a robust supply chain for the benefits of patients worldwide."

These approvals add to the previous 25 certifications from more than 10 global regulatory administrations. So far, WuXi Biologics has 13 certified DS and DP facilities on a global basis.


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