WuXi Biologics passes FDA GMP inspection at Wuxi Mashan
- Two-week unannounced FDA GMP inspection at the Wuxi Mashan site was passed.
- Inspection covered FDA‑approved monoclonal antibodies, bispecific antibodies, fusion proteins and enzyme products.
- Wuxi Mashan was the first Chinese biopharma facility approved by both FDA and EMA for commercial production and integrates DS and DP capabilities on one site.
- The site reports 100% success in over 600 regulatory and client audits across 13 years and has supported global launches of more than 20 biologics; the company has passed 49 regulatory inspections and holds 166 facility license approvals.
Inspection result
WuXi Biologics’ Wuxi Mashan drug substance and drug product manufacturing facilities successfully passed a two‑week, unannounced GMP inspection conducted by the U.S. Food and Drug Administration. The inspection covered multiple FDA‑approved products and is cited as reinforcing the company’s ability to supply commercial products to the U.S. market.
Scope of review
The FDA review included monoclonal antibodies, bispecific antibodies, fusion proteins and enzyme products produced at the site. The company states the outcome demonstrates adherence to FDA GMP requirements and validates its quality and operational systems for commercial manufacturing.
Site capabilities and track record
Wuxi Mashan was the first biopharmaceutical manufacturing facility in China approved by both the FDA and the European Medicines Agency for commercial production. The site combines drug substance and drug product operations on a single campus to streamline technology transfer, process scale‑up and commercial supply. Over the past 13 years it reports a 100% success rate across more than 600 regulatory and client audits and has supported the global launch of more than 20 biologics.
Compliance and network scale
As of end‑June 2026, the company reports having passed 49 regulatory inspections—including 22 by the FDA and EMA—secured 166 facility license approvals, and completed over 2,000 GMP quality audits by global clients. Its global network includes 26 drug substance and 19 drug product facilities.
Source: WuXi