WuXi’s late- and commercial-stage analytical and stability testing facilities, located in Shanghai’s Waigaoqiao Free Trade Zone, have successfully passed an FDA general  GMP inspection.  This achievement brings regulatory advantages and potential expedited  approval  to clients who use these WuXi services for their NDA/ANDA filings and commercial analytical and stability testing.  The facilities for clinical trial materials manufacturing, packaging, and labeling were also inspected and found to be in compliance.

This favorable FDA inspection outcome — along with last year’s MPA (EMA) approval— reflects our commitment to building operations with the highest standards of quality across our entire platform of R&D services.

Related links:

WuXi Manufacturing Facility Passes FDA Inspection
WuXi AppTec Receives CLIA Certification for its Genomics Clinical Laboratory
WuXi PharmaTech Receives Letter from AAALAC Commending Animal Care at Suzhou Toxicology Facility as “Exemplary”