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Shijiazhuang Sihua Pharmaceutical Group’s Epinephrine Hydrochloride Injection Approved

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Honors Announcement

发布时间：2024-11-05

【概要描述】 On November 5, the Class 3 chemical drug—epinephrine hydrochloride injection (1 ml: 10 mg)—submitted by Shijiazhuang Sihua Pharmaceutical Group 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 70 new products, bringing its total number of approved products that have passed the consistency evaluation to 140 specifications across 107 varieties.

Shijiazhuang Sihua Pharmaceutical Group’s Epinephrine Hydrochloride Injection Approved

On November 5, the Class 3 chemical drug—epinephrine hydrochloride injection (1 ml: 10 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 70 new products, bringing its total number of approved products that have passed the consistency evaluation to 107 varieties encompassing 140 dosage forms.

According to available information, epinephrine hydrochloride injection is primarily used to treat shock and maintain blood pressure during anesthesia, as well as to control paroxysmal supraventricular tachycardia. In July of this year, the active pharmaceutical ingredient (API) of epinephrine hydrochloride, submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of the group, was successfully approved, thereby becoming an API for use in marketed dosage forms.

According to data from MeneNet, domestic sales of norepinephrine injection reached RMB 68.35 million in 2020, with sales remaining around RMB 60 million in both 2021 and 2022. In July 2022, norepinephrine hydrochloride injection was designated as a nationally monitored shortage drug.

Currently, the Group has achieved remarkable results in the development of its epinephrine product portfolio. A series of new “API-plus-formulation” products have been successively approved, including isoprenaline hydrochloride injection and its API, norepinephrine bitartrate injection and its API, epinephrine API, and phenylephrine hydrochloride injection and its API. These innovations have become a new highlight of the company’s innovative development, effectively driving the optimization of the product mix toward higher value and greater innovation, and enabling a new leap forward in the company’s overall growth.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, aligned with national strategic priorities, and actively promoted integrated development of “active pharmaceutical ingredients plus finished dosage forms.” The proportion of high-end, complex formulations and specialty APIs in its R&D portfolio has steadily increased, effectively accelerating the enhancement of its innovation, industrial, and value chains.

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