WuXi STA, a subsidiary of WuXi AppTec, has announced its Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection (PAI) by the FDA.
During the 5-day inspection, the FDA inspector conducted an onsite assessment of the manufacturing facility and equipment, laboratories, quality management system, tablet production, material handling, computer control systems, and data integrity. Within the same week, the site also passed PAIs by the China NMPA for two drugs from its partners.
The company’s drug product services at the Shanghai Waigaoqiao site include solid-state development, pre-formulation, formulation development, and clinical to commercial manufacturing for a range of oral dosage forms.
It has reportedly passed more than 40 inspections from major regulatory agencies including FDA, EMA, China NMPA and Japan PMDA. Its eight sites across North America, Europe and Asia, follow the same quality system, ensuring consistent-quality products worldwide. To date, the company has supported 34 drug approvals globally.
Dr 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.”