Pharmaron Beijing's subsidiary, Kanglong Shaoxing, passed the on-site inspection by the US FDA.

date
15/09/2025
avatar
GMT Eight
Kanglong Huacheng (300759.SZ) announced that its wholly-owned subsidiary Kanglong Huacheng (Shaoxing) Pharmaceutical Co., Ltd. (referred to as...
Pharmaron Beijing (300759.SZ) announced that its wholly-owned subsidiary Pharmaron Beijing (Shaoxing) Pharmaceutical Co., Ltd. (referred to as "Kanglong Shaoxing") underwent a pre-approval inspection (PAI) for current Good Manufacturing Practice (cGMP) by the U.S. Food and Drug Administration (FDA) from May 29, 2025 to June 4, 2025. The inspection scope covered quality systems, material management systems, production management systems, equipment facilities systems, packaging and labeling systems, laboratory control systems, and other GMP systems. Recently, Kanglong Shaoxing received the on-site inspection report from the U.S. FDA. The inspection report confirms that Kanglong Shaoxing's production facilities successfully passed the on-site quality inspection by the U.S. FDA. According to the inspection report, Kanglong Shaoxing meets the cGMP quality standards for U.S. drugs and has been certified by the U.S. FDA.