WuXi STA Successfully Passes Four Pre-Approval Inspections by South Korea's Ministry of Food and Drug Safety at Three Manufacturing Sites in China

(2023年)

SHANGHAI, CHINA, October 12, 2022 – WuXi STA, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that its three manufacturing sites in China have successfully passed four remote pre-approval inspections (PAI) by South Korea's Ministry of Food and Drug Safety (MFDS).

Within four weeks, the MFDS completed four PAIs for three innovative drugs, including two API manufacturing inspections at the Changzhou site, one API manufacturing inspection at the Shanghai Jinshan site, and one drug product manufacturing inspection at the Shanghai Waigaoqiao site.

The successful completion of four inspections is another testimony to WuXi STA's high global quality standard across all sites in Asia, North America, and Europe. To date, WuXi STA has passed over 50 inspections from all major regulatory agencies, including US FDA, EMA, China NMPA, SwissMedic, and Japan PMDA. With the integrated CRDMO platform and the global standard quality system, WuXi STA has supported 36 new drug approvals since 2017 and the products WuXi STA manufactured have been launched in 105 countries around the world.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "I am pleased to see that our manufacturing sites successfully passed four pre-approval inspections by MFDS within a month. As a CRDMO committed to empowering more global partners, WuXi STA will maintain the highest global quality standard and strengthen our global R&D and manufacturing network to accelerate more innovative medicines for patients worldwide."