- Three WuXi facilities in Wuxi received GMP certification from Turkey's TITCK after a five-day inspection.
- The inspection covered two monoclonal antibody biologics produced for WuXi's clients.
- WuXi has passed 44 regulatory inspections, including 22 by the FDA and EMA, as of June 2025.
- WuXi operates 16 GMP-certified facilities globally, maintaining a 100% pass rate for FDA Pre-License Inspections.
GMP Certification Achievement
WuXi Biologics announced that three of its manufacturing facilities in Wuxi—MFG1, MFG2, and DP5—have received GMP certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK). This marks the first GMP inspection conducted by Turkey’s TITCK at WuXi Biologics, highlighting the company's commitment to international quality standards.
Inspection Details
The five-day onsite inspection focused on two monoclonal antibody biologics produced by WuXi Biologics for its clients. The facilities successfully passed TITCK’s comprehensive assessment, validating WuXi's capabilities in delivering high-quality services for global clients.
Regulatory Compliance
As of June 2025, WuXi Biologics has passed 44 regulatory inspections, including 22 by the FDA and the EMA. The company boasts a 100% pass rate for FDA Pre-License Inspections and has undergone over 1,700 GMP quality audits by global clients, including more than 200 audits by EU Qualified Persons.
Global Operations
WuXi Biologics operates 16 GMP-certified drug substance and drug product facilities worldwide. The company's world-class quality and compliance capabilities are central to maintaining client trust and supporting the development of multiple biologic therapeutics.
