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Home Three WuXi STA Facilities Pass Pre-Approval Inspection From NMPA
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29 Apr 2021

Three WuXi STA Facilities Pass Pre-Approval Inspection From NMPA

Three WuXi STA Facilities Pass Pre-Approval Inspection From NMPA

STA Pharmaceutical, a WuXi AppTec company (WuXi STA), a leading contract development and manufacturing organization (CDMO) announces that three of its sites in China have successfully passed pre-approval inspections (PAI) by the China National Medical Products Administration (NMPA) concurrently for an innovative drug from its partner. 

Following a successful PAI for Orelabrutinib with 4 sites inspected simultaneously a few months ago, this PAI is another comprehensive inspection for its integrated chemical, manufacturing, and control (CMC) platform for both drug substance and drug product, which once again proved WuXi STA's industry-leading capabilities.

This comprehensive 13-day PAI involved three WuXi STA sites in China spanning drug substance process R&D (Changzhou), drug substance manufacturing (Shanghai Jinshan) and drug product R&D and manufacturing (Shanghai Waigaoqiao). During these 13 days, auditors conducted a comprehensive inspection of the development and manufacturing conditions for this innovative drug. All three sites successfully passed without major or key observations. 

WuXi STA's quality system can support new drug applications in many countries and has successfully passed inspections from all major regulatory agencies including the US FDA, China NMPA, EU EMA and Japan PMDA. Received more than 200 client audits and 10 inspections from global agencies every year, WuXi STA keeps up a perpetual state of regulatory readiness, with real time GMP monitoring and an ingrained internal quality culture. 

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WuXi STA
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Chemistry, Manufacturing and Controls (CMC) Biopharmaceutical Products Contract Manufacturing of Dosage Form Drugs Contract Development and Manufacturing Organisations (CDMOs) and Contract Manufacturing Organisations (CMOs)