Monday, 21 October 2019

WuXi STA's new facility passes European MPA GMP inspection

27 March 2019 | News

WuXi STA has received FDA inspections at both its API manufacturing facility in Jinshan (Shanghai) and API R&D & manufacturing facility in Changzhou

STA Pharmaceutical Co., Ltd., (WuXi STA) - a subsidiary of WuXi AppTec - announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the European Medical Products Agency (MPA). The new facility was opened at the end of 2018, and the successful inspection demonstrates the outstanding quality control system and rapid development of WuXi STA's drug product services.

In 2017, WuXi STA merged with WuXi AppTec's Pharmaceutical Development Services unit, realizing a seamless integration of chemistry, manufacturing and control (CMC) services. Two new commercial drug product facilities - in Shanghai and Wuxi City - have come into operation, enabling WuXi STA to support solid dosage drug development from preclinical to commercial stages, with several phase III and commercial drug product projects underway.

WuXi STA has received FDA inspections at both its API manufacturing facility in Jinshan (Shanghai) and API R&D & manufacturing facility in Changzhou. As a leading global Contract Development and Manufacturing Organization (CDMO), WuXi STA has passed inspections by regulatory bodies in the U.S., Canada, EU, Switzerland, China, Australia and New Zealand to supply APIs and GMP advanced intermediates for partners.


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