Key highlights
- Three Wuxi facilities (MFG5, DP2, DPPC) received South Korea MFDS GMP certification to enable end-to-end commercial manufacture of a bispecific antibody for biliary tract cancer.
- MFDS on-site inspection found no critical or major findings.
- WuXi operates 15 GMP-certified drug substance and drug product facilities globally.
- As of end-2025, WuXi passed 46 regulatory inspections (22 by FDA/EMA), holds 136 facility licenses, and supports 25 commercial-manufacturing programs plus 74 Phase III projects.
MFDS GMP certification
Three Wuxi facilities — Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2) and Drug Product Packaging Center (DPPC) — received GMP certification from South Korea's Ministry of Food and Drug Safety, enabling end-to-end commercial manufacture of a bispecific antibody for biliary tract cancer.
Inspection outcome
The five-day on-site MFDS assessment reported no critical or major findings across the three facilities.
Integrated manufacturing capabilities
MFG5, DP2 and DPPC collectively provide drug substance manufacturing, drug product fill‑finish and customized packaging, supporting commercial supply of complex biologic therapies.
