Shijiazhuang Sihua Pharmaceutical Group’s generic 50ml fluconazole sodium chloride injection is the first to receive approval.
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Time:2022-01-24
On January 6, the generic version of fluconazole sodium chloride injection (50 ml: 0.1 g fluconazole and 0.45 g sodium chloride), developed by Shijiazhuang No.4 Pharmaceutical Group, became the first generic drug to receive a drug registration certificate from the National Medical Products Administration, and is deemed to have passed the evaluation of bioequivalence and therapeutic equivalence for generic drugs.
On January 6, the generic version of fluconazole sodium chloride injection (50 ml: 0.1 g fluconazole and 0.45 g sodium chloride), developed by Shijiazhuang Fourth Pharmaceutical Group, became the first generic drug to receive a drug registration certificate from the National Medical Products Administration, and is deemed to have passed the evaluation of bioequivalence and therapeutic equivalence for generic drugs.
It was introduced that fluconazole is a broad-spectrum antifungal drug primarily used to treat or prevent various fungal infections, including cryptococcal meningitis, coccidioidomycosis, invasive candidiasis, and mucosal candidiasis.
Previously, Shijiazhuang No.4 Pharmaceutical’s fluconazole tablets (50mg and 150mg) and fluconazole sodium chloride injection (100ml: 0.2g fluconazole and 0.9g sodium chloride) were the first to pass the evaluation of bioequivalence and therapeutic consistency for generic drugs. Among these, the 150mg specification of fluconazole tablets was the first in China to receive such approval, and the fluconazole sodium chloride injection (100ml: 0.2g fluconazole and 0.9g sodium chloride) successfully won a bid in the fifth round of national centralized drug procurement. The recent approval of the fluconazole sodium chloride injection (50ml: 0.1g fluconazole and 0.45g sodium chloride) will further enhance the Group’s product lineup in the anti-infective field.
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