WuXi Biologics’ Five Manufacturing Sites Pass U.S. FDA Pre-approval Inspections; First Commercial Prefilled Syringe Filling Plant Approved
July 23, 2025
Source: drugdu
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On July 21, WuXi Biologics announced that its five manufacturing sites successfully passed the U.S. Food and Drug Administration (FDA) pre-approval inspection (PLI) with zero critical findings and zero data integrity issues. The nine-day FDA inspection covered WuXi Biologics ' quality management system and the entire production process of its two bulk drug manufacturing plants (MFG1 and MFG5) and three drug product manufacturing plants (DP1, DP2, and DP5) in Wuxi, China. As the company's first commercial prefilled syringe (PFS) filling plant, DP5 passed the regulatory inspection for the first time, laying a solid foundation for it to provide high-quality prefilled syringe production solutions to global customers.
https://finance.eastmoney.com/a/202507213462123078.html
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