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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
Shijiazhuang Sihua Pharmaceutical Group’s New Product, Linezolid Dry Suspension, Approved
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发布时间：2024-04-23
【概要描述】
The pursuit of dreams knows no bounds, and innovation never pauses. On April 23, Shijiazhuang Sihua Pharmaceutical Group became the first domestic pharmaceutical company to obtain drug production registration approval for linezolid dry suspension for oral administration—classified as a Category 4 generic—with a specification of 5 mL:100 mg (each bottle containing 3 g of linezolid). The product has also passed the evaluation of quality and therapeutic equivalence for generic drugs, making it the group’s third approved linezolid formulation following the approvals of linezolid glucose injection (100 mL) and linezolid sodium chloride injection (300 mL), thereby further expanding the company’s product portfolio.
The pursuit of dreams knows no bounds, and innovation never pauses. On April 23, Shijiazhuang Sihua Pharmaceutical Group became the first domestic pharmaceutical company to obtain drug production registration approval for linezolid dry suspension for oral administration—classified as a Category 4 generic—with a specification of 5 mL: 100 mg (each bottle containing 3 g of linezolid). The product has also passed the evaluation of quality and therapeutic equivalence for generic drugs, making it the group’s third approved linezolid formulation following the approvals of linezolid glucose injection (100 mL) and linezolid sodium chloride injection (300 mL), thereby further expanding the company’s product portfolio.
Linezolid, an artificially synthesized oxazolidinone antibiotic, is currently approved in China for three dosage forms: injectable solution, tablets, and dry suspension. Among these, Shijiazhuang Sihua Pharmaceutical Group was one of the earliest developers and the first to obtain approval for the linezolid dry suspension.
According to available information, this product is indicated for the treatment of the following infections caused by susceptible strains of specific microorganisms: hospital-acquired pneumonia, community-acquired pneumonia, complicated skin and soft-tissue infections, uncomplicated skin and soft-tissue infections, and infections caused by vancomycin-resistant Enterococcus faecium, among others.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has focused on market demand, proactively implemented “active pharmaceutical ingredient plus formulation” strategies and differentiated innovation initiatives, and accelerated the development of age-friendly and pediatric-specific dosage forms such as dry suspensions, thereby continuously enhancing its capacity and level of service in support of the Healthy China initiative. To date, the group has steadily intensified its independent R&D and innovation efforts, expedited the industrialization of complex formulations, and seen a steady stream of groundbreaking R&D achievements. Among these, 80 drug varieties comprising 109 dosage forms have either passed or been deemed to have passed the consistency evaluation. In addition, six dry suspension products—cefaclor dry suspension, cefuroxime axetil dry suspension, azithromycin dry suspension, oseltamivir phosphate dry suspension, stibipentol dry suspension, and linezolid dry suspension—have been approved for marketing, providing robust momentum for optimizing the product portfolio and facilitating industrial transformation.
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Non-Commercial (Filing) – 2025-0091