STA Pharmaceutical Co., a subsidiary of WuXi AppTec, announces 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 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 intermediate manufacturing facility in Shanghai, Jinshan and at its drug product manufacturing facility in Shanghai, Waigaoqiao free trade zone. As a Contract Development and Manufacturing Organization (CDMO), WuXi STA is the first CMC platform (including both APIs and drug product) in China to have passed FDA inspection for new chemical entities.
It is also the first CDMO in China that is approved to supply APIs and GMP intermediates for branded commercial drugs by regulatory agencies in the USA, China, EU, Canada, Switzerland, Australia, and New Zealand.
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 WuXi STA is seeing from customers, as more products move into commercial production.
Currently, the facility employs more than 1000 people including 200 scientists and has three plants in operation. However, the company will continue to add more than 300 scientists and seven multi-functional plants within the next five years. As a purpose-built facility, Changzhouoffers an integrated one-site solution for partners to accelerate innovative APIs and advanced intermediates—from preclinical and clinical development through to global commercial launch.
(Source: STA Pharmaceutical Co., Ltd.)
