Pharmaron subsidiary passes US FDA inspection for Shaoxing API production base

Pharmaron (Shaoxing) Pharmaceutical Co., Ltd. underwent a cGMP pre-approval inspection (PAI) by the US FDA from May 29 to June 4, 2025. The inspection covered various GMP systems, including quality, material, production, equipment, packaging/labeling, and laboratory control. The subsequent Establishment Inspection Report confirmed Pharmaron Shaoxing's production facility successfully passed the inspection, adhering to US pharmaceutical cGMP quality standards and receiving FDA certification.

This marks the first time Pharmaron's Shaoxing commercial API production base has passed a US FDA pre-approval inspection for new drugs, and the second US FDA inspection passed by a company API production facility in China after Ningbo's facility in April 2025. This achievement signifies the company's quality system is aligned with international standards, qualifying it to continuously supply commercial innovative drug APIs to US and global markets.

Currently, Pharmaron has four commercial API production bases across China, the UK, and the US, all of which have passed US FDA inspections. This enables the company to provide commercial production solutions for innovative drug APIs to clients worldwide across different markets.