Kanglong Huacheng: Wholly-owned subsidiary passes on-site inspection by the US FDA.

Kanglong Huacheng announced that its wholly-owned subsidiary Kanglong Huacheng Pharmaceuticals Co., Ltd. underwent a cGMP pre-approval inspection by the U.S. FDA from May 29, 2025 to June 4, 2025. The inspection covered various aspects such as quality system, material management system, and production management system. Recently, Kanglong Shaoxing received an on-site inspection report issued by the U.S. FDA, confirming that its production facilities passed the inspection smoothly and met the cGMP quality standards for U.S. drugs, and passed the certification of the U.S. FDA. This is the first time that the company's Shaoxing active pharmaceutical ingredients commercial production base has passed the pre-approval inspection by the U.S. FDA, and it is also the second time following the inspection of the Ningbo active pharmaceutical ingredients production workshop in April 2025 that the company's active pharmaceutical ingredients production workshop in China has passed the U.S. FDA inspection.