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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
R&D Innovation Receives Another Boost: Shijiazhuang Sihua Pharmaceutical Group’s Betahistine Mesylate Tablets Approved
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发布时间：2024-07-16
【概要描述】
Recently, Shijiazhuang Sihua Pharmaceutical Group’s application for Class 4 chemical drug—betahistine mesylate tablets (6 mg)—received production registration approval and was deemed to have passed the consistency evaluation, making the company the first in China to obtain approval for this product. Prior to this, the betahistine mesylate API developed by the Group’s Guolong Pharmaceutical had already been registered as an API intended for use in marketed dosage forms. This represents another significant achievement resulting from the Group’s integrated “API-plus-formulation” development strategy.
Recently, Shijiazhuang Sihua Pharmaceutical Group’s application for Class 4 chemical drug—betahistine mesylate tablets (6 mg)—has been approved for manufacturing registration and is deemed to have passed the bioequivalence evaluation, making the company the first in China to receive approval for this product. Prior to this, the betahistine mesylate API developed by the Group’s Guolong Pharmaceutical had already been registered as an API intended for use in marketed dosage forms. This represents another significant achievement in the Group’s integrated “API-plus-formulation” development strategy.
According to available information, betahistine mesylate tablets are a class of vasodilatory drugs primarily used to treat conditions such as Meniere’s disease, Meniere’s syndrome, and vertigo and dizziness associated with vestibular disorders. Betahistine exists mainly in two salt forms: mesylate and hydrochloride, with the primary dosage forms including injectable solutions, oral liquids, and tablets. Data from MeneNet indicate that sales of betahistine tablets are roughly on par with those of injectable formulations.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has actively implemented an integrated “API-plus-formulation” development strategy, becoming a key driving force behind the synergistic integration of the industrial chain, innovation chain, and supply chain. The intensity of new-product development has continued to increase, yielding a steady stream of innovative achievements and repeatedly setting new records. To date in 2024, the group has secured approval for 53 new products, bringing the total to 95 drug varieties encompassing 127 dosage forms that have either passed or are deemed to have passed the consistency evaluation. Driven by technological innovation, Shijiazhuang Sihua Pharmaceutical Group is now forging ahead into a new era of high-quality development.
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