Pharmaron subsidiary passes U.S. FDA inspection for innovative drugs

Pharmaron (Shaoxing) Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Pharmaron Beijing Co., Ltd., has passed a U.S. FDA cGMP Pre-approval Inspection (PAI). The inspection, conducted between May 29, 2025, and June 4, 2025, covered various GMP systems including quality, materials management, production, equipment, facilities, packaging, labelling, and laboratory control. Pharmaron Shaoxing received an Establishment Inspection Report (EIR) confirming its compliance with U.S. cGMP pharmaceutical quality standards.

This marks the first time Pharmaron's commercial API production facilities in Shaoxing have passed a U.S. FDA pre-approval inspection for innovative drugs. Following a successful U.S. FDA on-site inspection of the company's API production facilities in Ningbo in April 2025, this latest achievement further reinforces Pharmaron's quality system alignment with international standards.

Currently, four of Pharmaron's commercial API production facilities across China, the U.K., and the U.S. have successfully passed U.S. FDA inspections. This enables the company to continuously supply commercial innovative drug APIs to the U.S. and global markets, providing tailored production solutions to clients worldwide.