New specifications of sitagliptin and metformin extended-release tablets approved
September 29, 2025
Source: drugdu
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Xuantai PharmaceuticalOn September 26, the company announced that its wholly-owned subsidiary, Jiangsu Xuantai Pharmaceutical Co., Ltd., received the "Notice of Approval of Supplementary Drug Application" from the National Medical Products Administration (NMPA). The NMPA approved the company's supplemental application for sitagliptin and metformin extended-release tablets to include 50 mg of sitagliptin phosphate (calculated as CHFNO3) and 500 mg of metformin hydrochloride per tablet. Currently marketed, the dosage form contains 50 mg of sitagliptin phosphate (calculated as CHFNO3) and 1000 mg of metformin hydrochloride per tablet. This newly approved dosage form will help better meet patient needs, enhance product competitiveness and market share, and positively impact the company's future performance.
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