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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 Doxofylline API Approved
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发布时间：2023-01-19
【概要描述】
Recently, the doxofylline API submitted by Hebei Guangxiang 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. This represents another innovative achievement resulting from Shijiazhuang Sihua Pharmaceutical Group’s proactive implementation of its “API-plus-formulation” development strategy. It is also the fourth new product to receive approval since the beginning of the year, following the approvals of 200 mL ciprofloxacin lactate sodium chloride injection, felodipine sustained-release tablets, and lacosamide injection, marking a strong start to the year for the company’s R&D and innovation efforts.
Recently, the doxofylline API submitted by Hebei Guangxiang 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. This represents another innovative achievement resulting from Shijiazhuang Sihua Pharmaceutical Group’s proactive implementation of its “API-plus-formulation” development strategy. It also marks the fourth new product to receive approval since the beginning of the year—following the approvals of 200 mL ciprofloxacin lactate sodium chloride injection, felodipine sustained-release tablets, and lacosamide injection—ushering in a strong start to the new year for the company’s R&D and innovation efforts. 。
According to reports, doxofylline is primarily used to treat bronchial asthma, chronic asthmatic bronchitis, and other respiratory difficulties caused by bronchospasm.
Previously, in 2020, Shijiazhuang Sihua Pharmaceutical’s doxofylline injection (10 mg:0.1 g), filed under the new Category 4 regulatory pathway, was approved for marketing and deemed to have passed the consistency evaluation. In February 2021, during the fourth round of national centralized drug procurement bidding, the company’s doxofylline injection (10 mg:0.1 g) won the contract. The recent approval of the doxofylline API will have a positive impact on the Group’s efforts to enhance product quality and operational efficiency for this product.
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