#China #Wuxi #WuXi Biologics #GMP Inspection #PMDA

WuXi Biologics Successfully Completes GMP Inspection by Japan PMDA

WuXi Biologics, known as WuXi Bio (stock code: 2269.HK), has recently announced a remarkable achievement in the pharmaceutical sector. The leading global Contract Research, Development, and Manufacturing Organization (CRDMO) successfully passed the Good Manufacturing Practice (GMP) inspection conducted by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This inspection, held in Wuxi, assessed the critical drug substance facilities known as MFG2 and MFG5, focusing on quality processes and the entire production system.

The inspection concluded without any issues, reinforcing WuXi Biologics' strong foothold in maintaining compliance with rigorous international standards. This marks an essential update in the company's ongoing mission to provide high-quality biologics solutions to their partners around the world.

With an impressive track record, WuXi Biologics has now successfully navigated 42 regulatory inspections, along with receiving 97 license approvals from various drug administration agencies globally, including in the U.S., Europe, China, Singapore, Japan, and Canada. This consistent performance highlights the reliability of its quality management system, aligning with the stringent regulatory requirements of the international healthcare landscape.

Dr. Chris Chen, the CEO of WuXi Biologics, expressed his views on this success, stating, "Our world-class quality system serves as the cornerstone of our sustainable growth and provides a strong foundation for our global network that supports our clients. WuXi Biologics remains dedicated to enabling global partners to deliver life-saving treatments with swift and effective processes, ultimately benefiting patients worldwide."

WuXi Biologics is recognized for its commitment to excellence in various aspects of their operations. With over 12,000 skilled employees across locations in China, the United States, Ireland, Germany, and Singapore, they offer comprehensive and cost-effective biologics discovery, development, and manufacturing solutions. As of the end of 2024, they are supporting an extensive portfolio of projects, including 817 integrated client projects and 21 in commercial manufacturing outside of COVID-related initiatives.

The organization is not only striving for operational excellence but also prioritizing Environmental, Social, and Governance (ESG) commitments. WuXi Biologics has integrated these responsibilities deeply into their corporate ethos and strategy, aspiring to become a leader in ESG practices within the CRDMO sector. Their facilities are equipped with next-generation biomanufacturing technologies and utilize clean-energy sources. Additionally, an ESG committee leads their comprehensive strategy, showcasing their commitment to sustainable practices in the biopharmaceutical industry.

In conclusion, WuXi Biologics continues to demonstrate its capability to adhere to global standards, reinforcing the trust and confidence of its partners worldwide. As the pharmaceutical landscape evolves, this commitment to quality and sustainability will undoubtedly play a pivotal role in the future of biologics production and innovations that benefit patients around the globe.