The five production plants of WuXi PharmaTech have passed the pre-approval inspection by the US FDA, and the commercial pre-filled syringe filling plant has obtained its first approval.

On July 21, WuXi Biologics announced that its five production facilities had zero critical findings and zero data integrity issues, successfully passing the pre-approval inspection by the U.S. Food and Drug Administration. The FDA inspection lasted for nine days, covering WuXi Biologics' quality management system and the entire production process of two bulk drug substance facilities and three drug product facilities located in Wuxi, China. As the company's first commercial pre-filled syringe filling production facility, DP5 passed the regulatory inspection for the first time, laying a solid foundation for providing high-quality pre-filled syringe production solutions to global customers.