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Shijiazhuang Sihua Pharmaceutical Group’s Calcium Gluconate and Sodium Chloride Injection (100 ml: 2 g/675 mg) and Potassium Chloride Granules Have Been Approved
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发布时间：2025-06-04
【概要描述】
On June 4, Shijiazhuang Sihua Pharmaceutical Group’s applications for two products—Calcium Gluconate and Sodium Chloride Injection (100 mL: 2 g/675 mg), a Class 3 chemical drug, and Potassium Chloride Granules—were both granted drug production registration approvals by the National Medical Products Administration on the same day, and are deemed to have passed the bioequivalence evaluation for generic drugs.
On June 4, Shijiazhuang Sihua Pharmaceutical Group’s applications for two products—Class 3 chemical drug calcium gluconate and sodium chloride injection (100 ml: 2 g/675 mg) and potassium chloride granules—received drug production registration approvals from the National Medical Products Administration on the same day, and are deemed to have passed the bioequivalence evaluation for generic drugs.
To date, the group has received approval for 25 new formulation products this year, bringing the total number of approved and evaluated products to 173 specifications across 129 varieties.
According to available information, calcium gluconate and sodium chloride injection is primarily used for calcium and chloride supplementation and is indicated for acute hypocalcemia, magnesium toxicity, and fluorosis.
Potassium chloride granules are widely used in clinical practice for the prevention and treatment of hypokalemia, primarily indicated for the management and prophylaxis of hypokalemia, with or without metabolic alkalosis. According to data from MeneNet, sales of potassium chloride granules in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 310 million in 2022, RMB 390 million in 2023, and RMB 350 million in 2024.
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Non-Commercial (Filing) – 2025-0091