WuXi Biologics Passes Japan PMDA GMP Inspection for Wuxi Facilities

• WuXi Biologics has successfully passed Japan’s PMDA GMP inspection for its drug substance facilities in Wuxi, China.

• The company has now completed 42 regulatory inspections and received 97 license approvals worldwide.

WuXi Biologics has successfully completed the Good Manufacturing Practice (GMP) inspection conducted by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its drug substance facilities, MFG2 and MFG5, in Wuxi, China. The inspection concluded without issues, reinforcing the company’s adherence to global regulatory standards.

The PMDA’s assessment covered the facilities’ quality control processes and overall production system. The positive outcome highlights WuXi Biologics’ capability to maintain compliance with international regulatory requirements.

With this latest inspection, WuXi Biologics has now passed 42 regulatory inspections and obtained 97 license approvals from drug administration agencies across multiple regions, including the United States, Europe, China, Singapore, Japan, and Canada. These achievements underline the company’s commitment to maintaining a robust and reliable quality system.

Dr. Chris Chen, CEO of WuXi Biologics, stated, “Our world-class quality system is the cornerstone to maintain the company’s strong sustainable growth and has laid a solid foundation for our global network to support our clients worldwide.”