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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
Attention! Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Seven New Finished-Product Formulations on the Same Day, Bringing the Total Number of Newly Approved Products This Year to 66
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发布时间：2025-09-06
【概要描述】
Pioneering innovation and striving for new heights. On September 5, seven new pharmaceutical formulations developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical Group—the Class 4 chemical drug arginine perindopril tablets (10 mg), the Class 3 chemical drugs progesterone injection (II) (1.112 ml: 25 mg), labetalol hydrochloride injection (20 ml: 100 mg), calcium chloride injection (10 ml: 1 g), compound electrolyte sodium acetate injection (500 ml), compound electrolyte injection (V) (500 ml), and levosalbutamol hydrochloride nebulized inhalation solution (3 ml: 0.63 mg)—were simultaneously granted manufacturing registration approval by the National Medical Products Administration.
Innovation and breakthroughs drive us to scale new heights. On September 5, Shijiazhuang Sihua Pharmaceutical Group received production registration approvals from the National Medical Products Administration for seven new dosage forms it had developed and submitted: Class 4 chemical drug arginine perindopril tablets (10 mg), as well as Class 3 chemical drugs—progesterone injection (II) (1.112 ml: 25 mg), labetalol hydrochloride injection (20 ml: 100 mg), calcium chloride injection (10 ml: 1 g), compound sodium acetate electrolyte injection (500 ml), compound electrolyte injection (V) (500 ml), and levosalbutamol hydrochloride nebulized inhalation solution (3 ml: 0.63 mg). These products are also deemed to have passed the consistency evaluation. Notably, the arginine perindopril tablets (10 mg) represent the second such approval in China.
According to available information, Compound Electrolyte Sodium Acetate Injection is indicated for the treatment of isotonic dehydration accompanied by or expected to result in mild metabolic acidosis, as well as for replenishing extracellular fluid and blood volume losses. Compound Electrolyte Injection (V) is suitable for adult patients and may be used as a source of water and electrolytes and as an alkalinizing agent. Progesterone Injection (II) is employed for supplemental progesterone therapy in assisted reproductive technologies (ART), particularly in women who are unable to use or cannot tolerate vaginal formulations. Arginine Perindopril Tablets are indicated for the treatment of hypertension and congestive heart failure. Labetalol Hydrochloride Injection is primarily used for the management of various forms of hypertension, especially hypertensive crises; it is also indicated for hypertension complicated by coronary artery disease or a history of angina pectoris or heart failure, for preoperative blood pressure control, for antihypertensive therapy in pheochromocytoma, and for gestational hypertension. Calcium Chloride Injection is mainly indicated for the treatment of acute hypocalcemia and magnesium toxicity. Levosalbutamol Hydrochloride Nebulized Inhalation Solution is primarily used for the treatment or prevention of bronchospasm associated with reversible obstructive airway diseases in adults and children aged 6 years and older.
In recent years, the Group has aligned itself with the intrinsic imperatives of innovative development and cutting-edge market demands, leveraging technological innovation to drive the continuous expansion and R&D of specialty generic drugs and active pharmaceutical ingredients, thereby steadily enriching its pipeline of new products. Previously, the Group received approval for Electrolyte Injection (II) (1,000 ml and 500 ml), Compound Sodium Acetate and Glucose Injection, and, in 2023, Guangxiang Pharmaceutical was granted approval for the active pharmaceutical ingredient Levosalbutamol Hydrochloride.
Since the beginning of this year, the Group has received approval for 66 new products, 51 of which are finished dosage forms. To date, a total of 152 drug varieties comprising 199 specifications have either passed or been deemed to have passed the Consistency Evaluation. The recent approval of seven new finished dosage forms marks the entry of the company’s innovation pipeline into a phase of intensive translation of research outcomes into commercial products, and the increasingly robust product portfolio will significantly enhance the resilience and accessibility of the product pipeline.
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