The Waigaoqiao base of Hequan Pharmaceutical successfully passed the pre-market inspection of the U.S. FDA for its first preparation project

Shanghai, China, January 4, 2022, WuXi AppTec subsidiary Hequan Pharmaceuticals announced that its Shanghai Waigaoqiao base will receive an innovative drug from the US FDA for its partners from October 22 to 26, 2021 Pre-Approval Inspection (PAI, Pre-Approval Inspection) for the development and production of formulations

FDA prosecutors carried out a five-day comprehensive on-site inspection, which included plant facilities and equipment, laboratories, quality management systems, preparation production, material management, computer control systems, and data integrity

In particular, it is worth mentioning that in the same week that it was inspected by the US FDA, Hequan Pharmaceutical’s Waigaoqiao base also received Chinese NMPA at the same time, and conducted research and development and production conditions for the two innovative drugs of its other two partners.

At present, the Waigaoqiao base of Hequan Pharmaceuticals can provide integrated R&D and production services from solid-state drug research, pre-prescription development, prescription development, to clinical and commercial GMP preparation product supply, and can provide various oral dosage forms.

As a global leader in the field of collaborative research, development and production of new drugs (CDMO), Hequan Pharmaceuticals has always regarded quality as its lifeline and core competitiveness

Dr.

I am very pleased that the preparation business platform of Hequan Pharmaceutical has passed the FDA pre-market inspection for the first time.