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Shijiazhuang Sihua Pharmaceutical Group Intensifies API Development; Norepinephrine Bitartrate Approved

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Honors Announcement

发布时间：2024-02-29

【概要描述】 On February 29, norepinephrine bitartrate, submitted by Hebei Guangxiang Pharmaceutical Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the fourth new API variety approved for the group in the first two months of this year, signaling that API development has entered a “fast track” of growth.

Shijiazhuang Sihua Pharmaceutical Group Intensifies API Development; Norepinephrine Bitartrate Approved

On February 29, North China Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, received approval from the National Medical Products Administration for its application to register norepinephrine bitartrate as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the fourth new API variety approved for the group in the first two months of this year, signaling that the company’s API development has entered a “fast track” of growth.

According to available information, norepinephrine bitartrate is an adrenergic receptor agonist used for blood pressure management in certain acute hypotensive conditions, such as post–adrenalectomy hypotension, sympathectomy-induced hypotension, poliomyelitis, spinal anesthesia, myocardial infarction, sepsis, transfusion reactions, and drug-induced hypotension.

To date this year, Shijiazhuang Sihua Pharmaceutical Group has secured approval for four new active pharmaceutical ingredients—lidocaine hydrochloride, rasagiline mesylate, isoprenaline hydrochloride, and norepinephrine bitartrate—bringing its total number of approved API varieties to 50 and further diversifying its product portfolio.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, aligned with national strategic development priorities, and actively pursued an integrated “API–formulation” business strategy. The company has strategically linked its innovation efforts to the industrial value chain, while intensifying R&D on high-end, complex generic drugs and innovative pharmaceuticals. At the same time, in response to domestic and international market demands, it has proactively developed specialty API products and secured international certifications for these products. Currently, the proportion of specialty APIs among the group’s pipeline of new products is steadily increasing, and the pace of commercialization is accelerating, making this area a new highlight of the company’s innovative growth.

“Innovation drives transformation, optimizes structure, and elevates capabilities, enabling breakthroughs beyond traditional boundaries and accelerating the extension of the API innovation value chain toward the mid- to high-end segments,” said a spokesperson for the group. The group noted that R&D innovation in APIs and the commercialization of research outcomes are gaining momentum, leading to improved quality and efficiency; the portfolio of signature, competitive products is expanding; and the supporting role of “little giant” enterprises specializing in niche, sophisticated, and innovative fields is steadily strengthening—collectively propelling a new leap forward in diversifying the company’s product mix.

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