Facility in Changzhou, China passes first FDA inspection and receives approval to manufacture two APIs.
The first preapproval inspection by the US Food and Drug Administration of WuXi SynTheAll Pharmaceutical (STA)’s new sold-dose API plant in Changzhou, China resulted in no observations and no written or verbal recommendations, according to the company.
The Changzhou site became operational in 2016. WuXi STA is expanding the location is stages, and today it consists of three plants that employ over 1000 people. The company currently has more than 60 APIs and intermediates under development and one new chemical entity that is commercially produced. With this latest inspection, WuXi STA received FDA approval for the manufacture of two APIs.
WuXi STA production facilities in Shanghai, Jinshan and Shanghai, Waigaoqiao have also passed FDA inspections.
Separately, WuXI Biologics recently announced that it will spend $392 million to build a biologics facility in Dundalk, Ireland that will employ 400 people. This announcement followed the completion just a few months ago of China’s largest single-use bioreactor manufacturing facility (total bioreactor capacity of 30,000 L). The Ireland plant will be the first production site for WuXi biologics outside of China. Construction will begin in early 2019 and be completed by the second quarter of 2021. The plant will include single-use bioreactors (total capacity 54,000 L) and be capable of performing continuous bioprocessing.