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Shijiazhuang Sihua Pharmaceutical’s Fluconazole Sodium Chloride Injection Has Passed the Consistency Evaluation

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Honors Announcement

发布时间：2021-01-22

【概要描述】 On January 21, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received notification that its fluconazole sodium chloride injection has been approved in the evaluation of generic drug quality and therapeutic equivalence.

On January 21, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received notification that its fluconazole sodium chloride injection has been approved in the evaluation of generic drug quality and therapeutic equivalence. To date, Shijiazhuang Sihua has had a total of 14 product specifications across 10 varieties pass the national evaluation of generic drug quality and therapeutic equivalence, or be deemed to have passed such an evaluation, placing the company among the industry leaders in both the number of approvals and the pace of progress.
According to reports, fluconazole is a broad-spectrum antifungal agent primarily used for the treatment and prevention of various fungal infections, including cryptococcal meningitis, coccidioidomycosis, invasive candidiasis, and mucosal candidiasis. As a triazole-class antifungal, fluconazole is widely employed in clinical practice for both the treatment and prophylaxis of fungal infections and is recommended as first-line therapy for multiple forms of candidiasis—as well as for primary prophylaxis of invasive fungal infections—by several domestic guidelines, including the “Expert Consensus on the Diagnosis and Treatment of Candidiasis,” the “Guidelines for the Diagnosis and Treatment of Invasive Fungal Infections in Critically Ill Patients,” and the “Clinical Practice Guidelines for the Diagnosis and Management of Invasive Fungal Diseases in Chinese Solid Organ Transplant Recipients.” This drug is listed in both the National Essential Medicines List and the National Basic Medical Insurance Catalogue.
Previously, in May 2020, Shijiazhuang Sihua Pharmaceutical’s fluconazole tablets (Yilikan) in the 150 mg and 50 mg strengths both passed the evaluation of generic drug quality and therapeutic equivalence.
Over the past two years, Shijiazhuang No.4 Pharmaceutical has pursued a coordinated approach to the development of innovative drugs, generic drugs, and active pharmaceutical ingredients, as well as to consistency evaluation studies, steadily building momentum and yielding substantial innovation outcomes. At the start of the new year, three generic drug quality and efficacy consistency evaluation projects—ambroxol hydrochloride injection, ciprofloxacin lactate sodium chloride injection, and fluconazole sodium chloride injection—have successively passed the consistency evaluation. Notably, ciprofloxacin lactate sodium chloride injection was the first among 83 domestic manufacturers of the same product to pass the evaluation, while fluconazole sodium chloride injection became the second in China to do so.

Keywords:

Shijiazhuang Sihua Pharmaceutical Wins Bids for Two Products in National Centralized Procurement

Shijiazhuang Sihua Pharmaceutical’s Ciprofloxacin Lactate and Sodium Chloride Injection Becomes the First in China to Pass the Generic Drug Consistency Evaluation

Shijiazhuang Sihua Pharmaceutical Wins Bids for Two Products in National Centralized Procurement

Shijiazhuang Sihua Pharmaceutical’s Ciprofloxacin Lactate and Sodium Chloride Injection Becomes the First in China to Pass the Generic Drug Consistency Evaluation