WuXi PharmaTech Facilities for Late - and Commercial-Stage Analytical and Stability Testing and Clinical-Trial Materials Manufacturing Pass FDA Audit
Apr 30, 2014
SHANGHAI, April 30, 2014 -- WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading pharmaceutical, biotechnology, and medical device R&D services company with operations in China and the United States, today announced that its analytical and stability testing facilities, located in Shanghai 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 clinical trial materials manufacturing for drug products (CTM), packaging and labeling facilities were also inspected and found to be in compliance.
"This favorable FDA inspection outcome, in addition to last year's MPA (EMA) approval, reflects the quality of our analytical and stability testing and CTM facilities, the robustness of our quality assurance system, and the high caliber of our employees," said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech. "We are committed to building operations with the highest standards of quality across our entire platform of R&D services."
About WuXi PharmaTech
WuXi PharmaTech (NYSE: WX) is a leading pharmaceutical, biotechnology, and medical device R&D services company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical, biotechnology and medical device companies with a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech's services are designed to help its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. The operating subsidiaries of WuXi PharmaTech are known as WuXi AppTec.
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