Pharmaron Beijing Co.,Ltd. (300759.SZ) announced that its wholly-owned subsidiary Pharmaron (Shaoxing) Pharmaceutical Co., Ltd. ("Pharmaron Shaoxing") underwent a current Good Manufacturing Practice (cGMP) Pre-Approval Inspection (PAI) conducted by the U.S. Food and Drug Administration (FDA) from May 29 to June 4, 2025. The inspection covered various GMP systems including quality systems, material management systems, production management systems, equipment and facility systems, packaging and labeling systems, and laboratory control systems.
Recently, Pharmaron Shaoxing received the on-site inspection report issued by the U.S. FDA. The inspection report confirmed that Pharmaron Shaoxing's production facilities successfully passed the FDA's on-site quality inspection. According to the inspection report, Pharmaron Shaoxing complies with U.S. pharmaceutical cGMP quality standards and has received FDA certification.