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Aug 18, 2014

WuXi Facility Gets FDA Thumbs-Up for API Production

  • WuXiPharmaTech announced that a manufacturing facility of its subsidiary Shanghai SynTheAll Pharmaceutical (STA) passed an FDA inspection to manufacture the active pharmaceutical ingredient (API) for an unnamed branded commercial drug. STA provides an integrated platform of services with small molecule APIs/intermediates development and manufacturing capabilities geared to help clients move their new chemical entities through preclinical and clinical development to commercial launch, according to WuXi.

    The firm says this is the first FDA inspection of STA's facilities for the manufacture of an API and adds that the subsidiary's manufacturing operations passed an FDA inspection to manufacture an advanced intermediate last year. Two months ago WuXi’s toxicology facility in Suzhou, China, passed a GLP inspection by the FDA. And last April the company broke ground on a new facility in Philadelphia to manufacture cell therapies.


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