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Kanglong Huacheng announced that its wholly-owned subsidiary Kanglong Huacheng (Shaoxing) Pharmaceutical Co., Ltd. underwent a pre-approval inspection by the US Food and Drug Administration (FDA) for current Good Manufacturing Practice (cGMP) from May 29, 2025 to June 4, 2025. The inspection covered various GMP systems including quality system, material management system, production management system, equipment and facilities system, packaging and labeling system, and laboratory control system. Kanglong Shaoxing has received an on-site inspection report from the US FDA confirming that its production facilities comply with US drug cGMP quality standards and has passed the US FDA certification. This is the first time Kanglong Huacheng Shaoxing's active pharmaceutical ingredient commercial production base has passed the FDA pre-approval inspection, and following the on-site inspection by the US FDA of Kanglong Huacheng's active pharmaceutical ingredient production workshop in Ningbo in April 2025, it is also the second time that Kanglong Huacheng's active pharmaceutical ingredient production workshop in China has passed the US FDA inspection.
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