Pharmaceutical company WuXi STA has announced that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou have passed two US FDA inspections.
FDA approved
The announcement marks WuXi STA’s seventh successful inspection from the FDA since 2013. The company’s Changzhou facility has established a variety of new technology platforms, including spray dried dispersion, continuous processing (flow chemistry), oligonucleotides and peptides.
"It's a point of great pride that our quality systems allow us to be inspected at short notice by any applicable regulatory agency in the world. In this case, we received two separate inspection notices from FDA only seven days and five days in advance of the inspections, respectively. It's an endorsement of the real time monitoring and quality culture we run across all parts of the company," commented Ms. Mei Hao, vice president of Quality at WuXi STA. "It's another key example of the rigorous nature of our global standard quality systems. It is also another milestone for our platform, and in our efforts to have geographically integrated capabilities for both drug product and drug substance."
"WuXi STA takes high priority on building quality system meeting global regulatory standards. These successful FDA inspections to ASU and Changzhou facility reflectsWuXi STA's commitment to 'quality first'. We will continue to enhance our platform with highest quality service to better enable our customers to bring better medicines faster for patients." added Dr Minzhang Chen, CEO of WuXi STA.