WuXi Biologics Again Passed GMP Inspection by Japan PMDA

Rhea-AI Summary

WuXi Biologics (2269.HK) has successfully passed a GMP inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its drug substance facilities MFG2 and MFG5 in Wuxi city. The inspection, which evaluated the facilities' quality processes and production system, concluded without issues.

The company has now achieved a total of 42 regulatory inspections and received 97 license approvals from drug administration agencies across multiple countries including the U.S., Europe, China, Singapore, Japan and Canada. This track record demonstrates the company's compliance with global regulatory standards and robust quality system.

Positive

• Passed PMDA GMP inspection without issues
• Achieved 42 successful regulatory inspections globally
• Obtained 97 license approvals across major markets

Negative

• None.

WUXI, China, Feb. 26, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has again passed the GMP inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its drug substance facilities (MFG2 and MFG5), in Wuxi city.

This onsite inspection covered the facilities' quality processes and the entire production system. It concluded without issues, demonstrating the company's robust expertise in meeting global regulatory requirements.

To date, WuXi Biologics has successfully passed 42 regulatory inspections and has received 97 license approvals from drug administration agencies across multiple countries and regions, including the U.S., Europe, China, Singapore, Japan and Canada. The company's track record of successful inspections underscores the reliability and full compliance of its quality system with global regulatory standards.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "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. WuXi Biologics will continue to enable global partners in delivering life-saving treatments with speed and efficacy, ultimately benefiting patients worldwide."

About WuXi Biologics 

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering 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 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

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

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SOURCE WuXi Biologics

FAQ

What was the outcome of WuXi Biologics' (WXXWY) recent PMDA inspection in 2025?

WuXi Biologics passed the GMP inspection by Japan's PMDA for its MFG2 and MFG5 drug substance facilities in Wuxi city without any issues.

How many regulatory inspections has WuXi Biologics (WXXWY) passed to date?

WuXi Biologics has successfully passed 42 regulatory inspections across multiple countries and regions.

How many license approvals does WuXi Biologics (WXXWY) currently hold?

WuXi Biologics has received 97 license approvals from drug administration agencies across the U.S., Europe, China, Singapore, Japan and Canada.

Which facilities of WuXi Biologics (WXXWY) were inspected by Japan's PMDA in 2025?

The PMDA inspection covered WuXi Biologics' drug substance facilities MFG2 and MFG5 located in Wuxi city.