We are pleased to announce STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, has secured Pre-Approval Inspection (PAI) for two APIs from the U.S. Food and Drug Administration for its R&D and manufacturing facility located in Changzhou, China. This is the first time that STA’s Changzhou facility has been inspected by the FDA.
The Changzhou facility – which opened in early 2016 and is situated on a site of 39 acres – has been designed to keep pace with the increasing demand STA is seeing from customers, as more products move into commercial production. As a purpose-built facility, Changzhou offers an integrated one-site solution for partners to accelerate innovative APIs and advanced intermediates – from preclinical and clinical development through to global commercial launch.
STA will continue to strengthen its global quality systems to meet and surpass even the most stringent regulatory requirements. This ensures the company provides the highest standard of quality services to its partners worldwide.