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Shijiazhuang Sihua Pharmaceutical Group’s Compound Sodium Acetate and Glucose Injection Has Been Approved and Is Deemed to Have Passed the Consistency Evaluation.

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Honors Announcement

发布时间：2024-12-02

【概要描述】 On December 2, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug—compound sodium acetate and glucose injection (200 mL; 500 mL)—received registration approval from the National Medical Products Administration and is deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs.

Shijiazhuang Sihua Pharmaceutical Group’s Compound Sodium Acetate and Glucose Injection Has Been Approved and Is Deemed to Have Passed the Consistency Evaluation.

On December 2, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug—compound sodium acetate and glucose injection (200 ml; 500 ml)—received registration approval from the National Medical Products Administration and is deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs.

According to available information, Compound Sodium Acetate and Glucose Injection is primarily indicated for situations in which oral administration is not feasible or adequate intake is insufficient, serving to replenish and maintain fluid and electrolyte balance while also providing energy. It represents the latest generation of sugar-containing sodium acetate–balanced crystalloid solutions, featuring a safer acetate buffering system, a more optimized electrolyte formulation, and a more appropriately tailored energy supply. In addition, it offers clearly defined pediatric dosing and administration guidelines as well as multiple dosage strengths, enabling more flexible meeting of the fluid replacement needs of patients across different age groups and thereby providing greater therapeutic options for both adult and pediatric clinical fluid management.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has adhered to a research-and-development strategy that integrates generic and innovative drug development, using the development of pediatric- and geriatric-friendly products as a key entry point to accelerate improvements in product accessibility. To date, 109 drug varieties comprising 144 dosage forms have either passed or been deemed to have passed the consistency evaluation.

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