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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
Good News! Shijiazhuang Sihua Pharmaceutical’s Dexmedetomidine Hydrochloride Injection (1 ml: 0.1 mg) Has Been Approved
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发布时间：2022-02-25
【概要描述】
On February 9, the company’s Class 3 chemical drug, dexmedetomidine hydrochloride injection (1 mL: 0.1 mg), was granted a Drug Registration Certificate by the National Medical Products Administration and is deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs.
Immediately following the Spring Festival holiday, Shijiazhuang Sihua Pharmaceutical Co., Ltd. announced another significant achievement in its research and development efforts: on February 9, the company’s Class 3 chemical drug—dexmedetomidine hydrochloride injection (1 ml: 0.1 mg)—received a Drug Registration Certificate from the National Medical Products Administration, which also deems the product to have passed the evaluation of quality and therapeutic equivalence for generic drugs.
According to reports, dexmedetomidine hydrochloride is an α2-adrenergic receptor agonist primarily used for sedation during endotracheal intubation and mechanical ventilation in patients undergoing general anesthesia, as well as for sedation in critically ill patients who have just been intubated and placed on mechanical ventilation. Dexmedetomidine hydrochloride injection is included in the National Medical Insurance Reimbursement List.
Previously, Shijiazhuang Sihua Pharmaceutical Co., Ltd. developed a 2 mL:0.2 mg formulation of dexmedetomidine hydrochloride injection, and Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, developed the corresponding API—dexmedetomidine hydrochloride—which were both approved in 2021. The recent approval of another dexmedetomidine hydrochloride injection formulation (1 mL:0.1 mg) will play a positive role in further enriching and optimizing the product portfolio for this drug, enhancing its market competitiveness, and accelerating the implementation of Shijiazhuang Sihua Pharmaceutical Group’s “API-plus-formulation” strategy.
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Non-Commercial (Filing) – 2025-0091