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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! Two Specifications of the Group’s Urapidil Hydrochloride Injection Have Been Approved Simultaneously
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发布时间：2023-06-02
【概要描述】
On June 1, just one day after the approval of Tedizolid Phosphate for Injection, Shijiazhuang Sihua Pharmaceutical Group simultaneously obtained drug production registration approvals from the National Medical Products Administration for two specifications of Urapidil Hydrochloride Injection—5 mL: 25 mg and 10 mL: 50 mg—both of which are deemed to have passed the consistency evaluation. According to reports, this marks the group’s 31st new product approved this year.
On June 1, just one day after the approval of tedizolid phosphate for injection, Shijiazhuang Sihua Pharmaceutical Group simultaneously obtained drug production registration approvals from the National Medical Products Administration for two specifications of urapidil hydrochloride injection—5 mL: 25 mg and 10 mL: 50 mg—both of which are deemed to have passed the consistency evaluation. According to reports, this marks the group’s 31st new product approved this year.
According to reports, urapidil hydrochloride injection is primarily used to treat hypertensive crises (such as abrupt and severe elevations in blood pressure), severe and very severe hypertension, and refractory hypertension.
Previously, the group’s application for urapidil hydrochloride API had already been approved by the National Medical Products Administration and registered as an API used in marketed dosage forms. The recent approval of urapidil hydrochloride injection will inject new momentum into the group’s market development of this product.
A responsible official from the Group’s R&D Center stated that, in recent years, the Group has implemented an integrated “API-plus-formulation” development strategy, proactively aligning its innovation chain with the industrial value chain. Building on its portfolio of approved APIs, the Group has steadily accelerated the research and development of related formulation products, thereby effectively bolstering the company’s targeted efforts to strengthen its strategic focus and enhance the quality and efficiency of its formulation operations. To date, a total of 64 product specifications across 49 varieties have either passed or been deemed to have passed the National Consistency Evaluation for Generic Drugs, marking the beginning of a concentrated period of harvest for the Group’s innovation achievements and providing strong impetus for Shijiazhuang Sihua Pharmaceutical to accelerate its high-quality development and enter a fast-track growth trajectory.
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