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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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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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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’s Guolong Pharmaceutical Receives Approval for Ambroxol Hydrochloride API
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发布时间：2025-09-15
【概要描述】
Spring blossoms and autumn harvests—good news keeps pouring in. On September 15, the ambroxol hydrochloride API developed by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang No.4 Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms. To date, the Group boasts a total of 84 API products, 38 of which are manufactured by Guolong Pharmaceutical.
Spring blossoms and autumn harvests—good news keeps pouring in. On September 15, the ambroxol hydrochloride API developed by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms. To date, the Group boasts a total of 84 API products, 38 of which are manufactured by Guolong Pharmaceutical.
According to available information, ambroxol hydrochloride is indicated for acute and chronic pulmonary diseases accompanied by abnormal sputum secretion and impaired mucus clearance. These include exacerbations of chronic bronchitis, asthmatic bronchitis, and bronchial asthma for mucolytic therapy, as well as prophylactic treatment of postoperative pulmonary complications; it is also used in the management of infant respiratory distress syndrome (IRDS) in preterm infants and newborns.
In recent years, the Group has aligned its strategic planning with market demand and its own competitive strengths, systematically developing a product portfolio that includes ambroxol hydrochloride large-volume injectables, small-volume injectables, and oral formulations. The series of formulations it has developed have successively passed the evaluation of generic drug quality and therapeutic equivalence. The recent approval of the ambroxol hydrochloride API will further strengthen the synergistic advantages across the entire value chain for this product, comprehensively enhance the Company’s overall competitive edge in the respiratory pharmaceutical segment, and provide new impetus for accelerating the integrated development of “API + formulation.”
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Non-Commercial (Filing) – 2025-0091