The solid-dose API operation of China’s WuXi had its first visit by FDA inspectors at a new plant in Changzhou, China, and the company says it aced it.
The facility won FDA approval for two APIs during a preapproval inspection that was concluded with no observations, WuXi’s SynTheAll Pharmaceutical (STA) said Monday.
“The Changzhou facility passing its first FDA inspection, with no observations, even with no written or verbal recommendations, is yet further proof of our commitment to the highest possible quality standards,” WuXi STA CEO Minzhang Chen said in a statement.
The CDMO has previously passed FDA inspections at its production sites in Shanghai, Jinshan and Shanghai, Waigaoqiao.
The site in Changzhou opened in 2016 and currently has three plants and more than 1,000 employees, including 200 scientists, the company said. It is being built in stages but when all is said and done, it will include more than 500 scientists and 1,500 cubic meters of reactor volume. It currently has more than five dozen APIs and/or intermediates under development and one NCE in commercial production.
STA is not part of WuXi's biologics operations, which the company also is expanding. Last month, WuXi Biologics announced plans to invest €325 million ($392 million) to build a biologics facility in Dundalk, Ireland, and create a campus of 26 hectares (2.8 million square feet). The project is its first outside of China where it currently boasts the largest biologics plant build on single-use bioreactor technology.