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Shijiazhuang Sihua Pharmaceutical Group’s Compound Electrolyte Injection (II) Receives Concurrent Approval for Two Specifications
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发布时间：2023-04-21
【概要描述】
4月20日，石家庄四药集团申报的复方电解质注射液（Ⅱ）（1000ml及500ml）两规格新产品同时获得国家药监局药品生产注册批件，其中，1000ml为国内首家视同通过一致性评价，500ml为国内第二家视同通过一致性评价。截至目前，今年该集团已有21个新产品获批，研发创新进入集中收获期。
On April 20, Shijiazhuang Sihua Pharmaceutical Group received approval from the National Medical Products Administration for the registration of two new specifications of its Compound Electrolyte Injection (II)—1,000 mL and 500 mL. Notably, the 1,000-mL formulation is the first in China to be deemed to have passed the consistency evaluation by default, while the 500-mL formulation is the second such case nationwide. To date this year, the group has secured approval for a total of 21 new products, signaling that its R&D and innovation efforts have entered a phase of concentrated product launches.
According to reports, Compound Electrolyte Injection (II) is primarily indicated for the treatment of isotonic dehydration accompanied by or expected to result in acidosis, as well as for replenishing extracellular fluid losses.
Following the approval of 16 new products in the first quarter, the group saw another five new products—tetracycline phosphate API, terbutaline sulfate nebulizer solution (1 ml: 2.5 mg), peritoneal dialysis solution (lactate-based G-2.5%), and compound electrolyte injection (II) (1,000 ml and 500 ml)—approved in April. This steady expansion of the product portfolio is providing fresh momentum for further optimizing the company’s product mix and strengthening its competitive advantages.
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