-
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
-
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.
-
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.
-
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.
-
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 50 mL Fluconazole Sodium Chloride Injection Generic Drug Receives First Approval
Category:
发布时间：2022-01-24
【概要描述】
On January 6, the generic version of fluconazole sodium chloride injection (50 mL: fluconazole 0.1 g and sodium chloride 0.45 g) developed by Shijiazhuang Sihua Pharmaceutical Group became the first to receive a drug registration certificate issued by the National Medical Products Administration, and is deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs.
On January 6, the generic version of fluconazole sodium chloride injection (50 mL: fluconazole 0.1 g and sodium chloride 0.45 g) developed by Shijiazhuang Sihua Pharmaceutical Group became the first to receive a drug registration certificate issued by the National Medical Products Administration, and is deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs.
According to the introduction, fluconazole is a broad-spectrum antifungal agent primarily used for the treatment or prevention of various fungal infections, including cryptococcal meningitis, coccidioidomycosis, invasive candidiasis, and mucosal candidiasis.
Previously, Shijiazhuang Sihua Pharmaceutical’s fluconazole tablets (50 mg and 150 mg) and fluconazole sodium chloride injection (100 mL: fluconazole 0.2 g and sodium chloride 0.9 g) were the first to pass the bioequivalence and therapeutic equivalence evaluation for generic drugs. Notably, the 150-mg formulation of fluconazole tablets was the first in China to receive such approval, while the fluconazole sodium chloride injection (100 mL: fluconazole 0.2 g and sodium chloride 0.9 g) was successfully selected in the fifth round of national centralized drug procurement. The recent approval of the fluconazole sodium chloride injection (50 mL: fluconazole 0.1 g and sodium chloride 0.45 g) will further enhance the Group’s product portfolio in the anti-infective therapeutic area.
Keywords:
Recommended News
Share to
SERVICE HOTLINE
Address: Shimen Building, No. 8 Xingye Street, Shijiazhuang Economic and Technological Development Zone
Tel.: +86-311-67167130
Email: office@sjzsiyao.com
Mobile site
E code
Non-Commercial (Filing) – 2025-0091