Wuxi STA, a subsidiary of WuXi AppTec, said its Waigaoqiao facility near Shanghai passed its first FDA drug product preapproval inspection.
The U.S. regulator completed the inspection during five days in late October. The review included a comprehensive assessment of the facility, equipment, labs, quality management, tablet production, data integrity and other elements of the manufacturing process, WuXi said.
During the same time frame as the FDA inspection, the company said the facility successfully passed two additional preapproval inspections conducted by China’s regulatory agency, the NMPA, for two innovative drugs from its partners.
“I am very pleased that our drug product platform in Waigaoqiao has successfully passed its first PAI by the U.S. FDA,” Minzhang Chen, co-chief executive of WuXi AppTec and chief executive of WuXi STA, said in a statement. “It is another milestone that the site starts to provide commercial drug product manufacturing services to the U.S. market.”
The new facility includes solid-state development, preformulation, formulation development and clinical to commercial manufacturing that spans a range of oral dosage forms.
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