WuXi STA: FDA pre-approval of Shanghai Waigaoqiao site
WuXI STA has announced its Waigaoqiao site in Shanghai, China, as successfully passed the first drug product pre-approval inspection (PAI) by the US Food and Drug Administration (FDA). During the five-day inspection in October, the FDA inspector assessment included manufacturing facility and equipment, laboratories, quality management system, tablet production, material handling, computer control systems, and data integrity.
Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA, said, “I am very pleased that our drug product platform in Waigaoqiao has successfully passed its first PAI by the US FDA. It is another milestone that the site starts to provide commercial drug product manufacturing services to the US market. With our industry-leading global CMC platform and proven quality system, we strive to empower more partners to accelerate their innovative medicines to market for patients worldwide.”
