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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 U.S. FDA for cGMP 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 complied with U.S. drug cGMP quality standards and obtained certification from the U.S. FDA. This is the first time that the company's Shaoxing active pharmaceutical ingredient commercial production base passed the pre-approval inspection by the U.S. FDA, and it is also the second time that the company's active pharmaceutical ingredient production workshop in China passed the inspection by the U.S. FDA following the inspection in April 2025.
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