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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Sodium Bicarbonate Injection (10 mL: 0.84 g) by Shijiazhuang Sihua Pharmaceutical Group Approved
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发布时间：2025-03-10
【概要描述】
On March 10, the Class 3 sodium bicarbonate injection (10 mL: 0.84 g) developed by Shijiazhuang Sihua Pharmaceutical Group was approved for registration by the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation for generic drugs. This marks the ninth formulation product to receive such approval since the beginning of this year. To date, the Group has a total of 157 specifications across 118 drug varieties that have successfully passed the evaluation.
On March 10, the Class 3 sodium bicarbonate injection (10 mL: 0.84 g) developed by Shijiazhuang Sihua Pharmaceutical Group was approved for registration by the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation for generic drugs. This marks the ninth formulation product to receive such approval since the beginning of this year. To date, the Group has a total of 157 specifications across 118 drug varieties that have successfully passed the evaluation.
According to available information, sodium bicarbonate injection is an acid–base balance–regulating medication primarily indicated for the treatment of metabolic acidosis, urinary alkalinization, and, when administered by intravenous infusion, non-specific therapeutic effects in cases of certain drug poisonings.
To date, the Group has received approval for three specifications of sodium bicarbonate injection: 50 mL: 4.2 g, 250 mL: 12.5 g, and 10 mL: 0.84 g, covering both infusion and intravenous injection formulations, thereby gradually establishing a product series. In February 2024, the Group’s sodium bicarbonate injection (250 mL: 12.5 g) was recognized as one of the first batch of nationally patent-intensive products. With the continued refinement of the sodium bicarbonate injection product portfolio, the Group’s market penetration in the field of acid–base balance–regulating drugs is expected to further increase.
Sodium bicarbonate injection, as an injectable product with significant market potential, boasts a promising outlook. According to data from Mene.net, in 2023 the sales of this product across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 660 million, with sales reaching RMB 290 million in the first half of 2024.
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Non-Commercial (Filing) – 2025-0091