WuXi Facility Passes FDA Inspection for Manufacture of API
SHANGHAI, Aug. 18, 2014 /PRNewswire/ -- WuXiPharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that a manufacturing facility of WuXi's wholly owned subsidiary Shanghai SynTheAll Pharmaceutical Co. Ltd. (STA) passed an FDA inspection in July for the manufacture of the active pharmaceutical ingredient (API) for a branded commercial drug.
This represents the first FDA inspection of STA's facilities for the manufacture of an API. Last year, STA's manufacturing operations passed an inspection by the FDA for the manufacture of an advanced intermediate.
STA's integrated platform of services, extending from process research to research manufacturing to commercial manufacturing, helps the company's clients move their new chemical entities through preclinical and clinical development to global commercial launch.
"We are very pleased to have passed a second FDA inspection of our manufacturing facilities," said Dr. Ge Li, Chairman and CEO of WuXiPharmaTech. "These favorable outcomes reflect our dedication to maintaining the highest quality standards throughout our organization."
As a research-driven and customer-focused company, WuXiPharmaTech (Cayman) Inc. provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXiPharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXiAppTec is the name for the operating subsidiaries of WuXiPharmaTech. Please visit http://www.wuxiapptec.com.
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SOURCE WuXi PharmaTech