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WuXi STA Changzhou Site Passes First U.S. FDA Inspection

The integrated R&D and manufacturing facility is expecting more products to go into commercial production post approval

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By: Tim Wright

Editor-in-Chief, Contract Pharma

STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, said that its active pharmaceutical ingredient (API) R&D and manufacturing facility located in Changzhou, China has secured Pre-Approval Inspection (PAI) for two APIs from the U.S. Food and Drug Administration (FDA)-with no Form 483s issued. This is the first time that WuXi STA’s Changzhou facility has been inspected by the FDA. WuXi STA has already passed several inspections from the FDA at its API and advanced intermediat...

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