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Shijiazhuang Sihua Pharmaceutical Group’s Isoprenaline Hydrochloride Injection in a New Specification Has Been Approved Following Evaluation

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Honors Announcement

发布时间：2025-09-19

【概要描述】 On September 19, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug—Isoprenaline Hydrochloride Injection (5 mL: 1 mg)—received approval for drug manufacturing registration from the National Medical Products Administration and is deemed to have passed the consistency evaluation. This dosage form marks the second such approval in China, following the group’s July 2024 approval of Isoprenaline Hydrochloride Injection (1 mL: 0.2 mg). Since the beginning of this year, the group has secured approval for a total of 54 new dosage-form products, bringing the cumulative number of products that have either passed or are deemed to have passed the consistency evaluation to 202 specifications across 153 product varieties.

Shijiazhuang Sihua Pharmaceutical Group’s Isoprenaline Hydrochloride Injection in a New Specification Has Been Approved Following Evaluation

On September 19, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug—Isoprenaline Hydrochloride Injection (5 mL: 1 mg)—received approval for drug manufacturing registration from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation. This dosage form marks the second such approval in China, following the group’s July 2024 approval of Isoprenaline Hydrochloride Injection (1 mL: 0.2 mg). Since the beginning of this year, the group has secured approval for a total of 54 new dosage-form products, bringing the cumulative number of products that have either passed or are deemed to have passed the bioequivalence evaluation to 202 specifications across 153 product varieties.

According to available information, isoprenaline hydrochloride injection is indicated for the treatment of cardiogenic or septic shock, complete atrioventricular block, and cardiac arrest. Data from MeneNet show that in 2023, sales of isoprenaline hydrochloride injection across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 95 million, rising to RMB 98 million in 2024.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has taken meeting public health needs and industrial-chain requirements as its starting point, and, in conjunction with an integrated “active pharmaceutical ingredient–finished dosage form” development strategy, has undertaken systematic planning and R&D for its epinephrine product portfolio. Previously, the isoprenaline hydrochloride API developed by the Group’s Guangxiang Pharmaceutical was approved in January 2024; the recent approval of isoprenaline hydrochloride injection (5 mL: 1 mg) will further expand this product line and create favorable conditions for meeting diversified market demands.

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On the same day, two blockbuster products from Shijiazhuang Sihua Pharmaceutical Group—the levamlodipine besylate tablets (2.5 mg and 5 mg) and magnesium sulfate injection (5 mL: 2.5 mg)—received approval for expanded indications.

Shijiazhuang Sihua Pharmaceutical Group’s Guolong Pharmaceutical Receives Approval for Ambroxol Hydrochloride API