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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
Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Two New Specialty Active Pharmaceutical Ingredients: Vonoprazan Fumarate and Dronedarone Hydrochloride
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发布时间：2024-12-16
【概要描述】
On December 13, fumaric acid vonoprazan, developed and submitted for approval by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, and dronedarone hydrochloride, submitted by Hebei Guolong Pharmaceutical Co., Ltd., were both approved by the National Medical Products Administration and registered as active pharmaceutical ingredients for use in marketed dosage forms; notably, dronedarone hydrochloride marks the third such approval granted to a domestic enterprise. To date, the Group’s portfolio of API products has expanded to 66.
On December 13, fumaric acid vonoprazan, developed and submitted for approval by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, and dronedarone hydrochloride, submitted by Hebei Guolong Pharmaceutical Co., Ltd., were both approved by the National Medical Products Administration and registered as active pharmaceutical ingredients for use in marketed dosage forms; notably, dronedarone hydrochloride marks the third such approval granted to a domestic enterprise. To date, the Group’s portfolio of API products has expanded to 66.
According to available information, vonoprazan fumarate is primarily used for the treatment of reflux esophagitis; dronedarone hydrochloride is an antiarrhythmic agent.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation and aligned with national strategic development priorities, actively advancing an integrated “API–formulation” business strategy. The company has strategically aligned its innovation efforts with 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 APIs and pursued international regulatory approvals for these products, gradually establishing an API innovation landscape characterized by specialty APIs as the core and bulk APIs as the supporting pillar. Currently, the proportion of specialty API development within the group is steadily increasing, with 66 approved specialties and markedly accelerated commercialization, making this area a new highlight of the company’s innovation-driven growth.
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