Three WuXi STA facilities pass pre-approval inspection from NMPA
Three sites concurrent PAI
The achievement validates the company's CMC capabilities and quality
Three WuXi STA sites in China have successfully passed pre-approval inspections (PAI) by the China National Medical Products Administration (NMPA) for an innovative drug from our partner.
This is our second end-to-end commercial drug, validating our integrated chemical, manufacturing, and control (CMC) platform capability and quality system.
The sites span drug substance process R&D (Changzhou), drug substance manufacturing (Shanghai Jinshan), and drug product R&D and manufacturing (Shanghai Waigaoqiao) concurrently.
Following a successful PAI for Orelabrutinib with four sites inspected simultaneously a few months ago, this third site PAI is another comprehensive inspection for its integrated CMC platform for both drug substance and drug product, which once again proves WuXi STA's industry-leading capabilities.
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