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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
More than 200 product specifications have passed evaluation! Shijiazhuang Sihua Pharmaceutical Group’s Calcium Gluconate and Sodium Chloride Injection (100 ml: 1 g/0.8 g) and Moroxydine Hydrochloride and Sodium Chloride Injection (100 ml) have been approved.
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发布时间：2025-09-15
【概要描述】
Innovation drives us to reach farther, and relentless progress propels us forward. On September 15, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug—Calcium Gluconate and Sodium Chloride Injection (100 mL: 1 g/0.8 g)—and its Class 4 chemical drug—Mornidazole and Sodium Chloride Injection (100 mL)—both received manufacturing registration approval from the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation. Since the beginning of this year, the Group has secured approval for a total of 53 new dosage forms. To date, a cumulative total of 153 drug varieties comprising 201 product specifications have either passed or are deemed to have passed the consistency evaluation.
Innovation drives us toward lasting success, and we forge ahead with unwavering determination. On September 15, Shijiazhuang Sihua Pharmaceutical Group received production registration approvals from the National Medical Products Administration for two formulations on the same day: Class 3 chemical drug Calcium Gluconate and Sodium Chloride Injection (100 mL: 1 g/0.8 g) and Class 4 chemical drug Moroxydine Hydrochloride and Sodium Chloride Injection (100 mL). Both formulations are deemed to have passed the consistency evaluation. Since the beginning of this year, the Group has secured approval for a total of 53 new formulation products. To date, a cumulative total of 153 drug varieties comprising 201 dosage forms have either passed or been deemed to have passed the consistency evaluation.
According to available information, Calcium Gluconate and Sodium Chloride Injection is indicated for acute hypocalcemia, magnesium toxicity, and fluorosis. Moroxydine Hydrochloride and Sodium Chloride Injection is indicated for the following infections in adults (≥18 years) caused by susceptible bacteria: gynecological pelvic inflammatory disease (including endometritis, salpingitis, tubo-ovarian abscess, and pelvic peritonitis), as well as suppurative and gangrenous appendicitis when used in conjunction with surgical treatment. Data from MeneNet show that in 2023, sales of Moroxydine Hydrochloride and Sodium Chloride Injection across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 420 million, declining to RMB 330 million in 2024, underscoring its significant clinical value.
The newly approved Calcium Gluconate and Sodium Chloride Injection (100 mL: 1 g/0.8 g) joins the Group’s previously approved products—Calcium Gluconate and Sodium Chloride Injection (100 mL: 2 g/675 mg) and Calcium Gluconate Injection—both of which were approved in June and July 2025, thereby forming a comprehensive calcium formulation product portfolio.
Notably, the Group’s Guangxiang Pharmaceutical obtained approval for the active pharmaceutical ingredient moxifloxacin nitrate in August 2025 and, just one month later, successfully launched the corresponding finished dosage form. This efficient synergy between the API and the formulation fully demonstrates the effectiveness of the Group’s ongoing efforts to advance integrated API–formulation development.
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Non-Commercial (Filing) – 2025-0091