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WuXi Facility Passes FDA API Manufacture Inspection

Published: Wednesday, August 20, 2014
Last Updated: Wednesday, August 20, 2014
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Company's wholly owned subsidiary Shanghai SynTheAll Pharmaceutical (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.” 

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