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Shijiazhuang Sihua Pharmaceutical Group’s Potassium Chloride and Sodium Chloride Injection (250 ml and 500 ml) Received Approval on the Same Day in Two Specifications
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发布时间：2025-07-11
【概要描述】
On July 10, two new specifications of Class 4 chemical drug potassium chloride–sodium chloride injection (250 mL and 500 mL), developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical Group, simultaneously received manufacturing registration approvals from the National Medical Products Administration and are deemed to have passed the consistency evaluation. According to reports, these two specifications represent the second such approvals granted in China.
On July 10, two new injectable formulations of chemical drug Class 4—potassium chloride and sodium chloride injection (250 mL and 500 mL)—developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical Group simultaneously received manufacturing registration approvals from the National Medical Products Administration, and are deemed to have passed the consistency evaluation. According to reports, these two specifications represent the second such approvals granted in China.
To date, the Group has had a total of 137 drug varieties and 183 dosage forms either approved or deemed to have passed the consistency evaluation.
According to available information, Potassium Chloride and Sodium Chloride Injection is a combination preparation of potassium chloride and sodium chloride, indicated for the treatment of hypokalemia caused by various etiologies; for the prevention of hypokalemia; and for frequent, multifocal premature beats or rapid arrhythmias resulting from digitalis toxicity.
According to data from MeneNet, sales of potassium chloride–sodium chloride injection in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 27.43 million in 2023 and about RMB 26.17 million in 2024.
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Non-Commercial (Filing) – 2025-0091