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Shijiazhuang Sihua Pharmaceutical Group’s Epinephrine Hydrochloride Injection (1 ml: 1 mg) Has Been Approved
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发布时间：2025-03-14
【概要描述】
On March 14, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug application for Epinephrine Hydrochloride Injection (1 ml: 1 mg) received approval for drug production registration from the National Medical Products Administration and is deemed to have passed the consistency evaluation. To date this year, the group has obtained approval for 10 new dosage-form products, bringing its total number of approved products that have passed the consistency evaluation to 158 specifications across 119 product varieties.
On March 14, the Class 3 chemical drug—epinephrine hydrochloride injection (1 ml: 1 mg)—submitted by Shijiazhuang Sihua Pharmaceutical Group was granted a drug production registration approval by the National Medical Products Administration and is deemed to have passed the consistency evaluation. To date this year, the group has received approval for 10 new dosage-form products, bringing its total number of approved and evaluated products to 158 specifications across 119 varieties.
According to available information, epinephrine hydrochloride injection is the primary resuscitation drug used in cardiopulmonary resuscitation for cardiac arrest. It is also indicated for the treatment of severe respiratory distress caused by bronchospasm, for the rapid relief of anaphylactic shock induced by certain medications, and for prolonging the duration of action of infiltrative local anesthetics. Data from MeneNet show that in 2023, sales of epinephrine hydrochloride injection across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 270 million, with sales reaching RMB 120 million in the first half of 2024.
In recent years, the Group has placed great emphasis on the development of emergency and critical-care medications. In line with the integrated “API–formulation” development strategy, the Group has systematically planned and developed its epinephrine product portfolio, resulting in an integrated product matrix comprising eight key offerings: isopropyl epinephrine hydrochloride injection and its API, norepinephrine bitartrate injection and its API, epinephrine API, oxymetazoline hydrochloride injection and its API, and epinephrine hydrochloride injection. This comprehensive product lineup has created favorable conditions for meeting diversified market demands.
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Non-Commercial (Filing) – 2025-0091