Fluconazole

Fungal infection is one of the common infectious diseases in clinical practice. Among them, deep fungal infection has long been a key and difficult point in clinical diagnosis and treatment due to its insidious onset and high mortality rate. Fluconazole is a triazole antifungal drug. It exerts broad-spectrum antifungal activity by highly selectively inhibiting the 14α-sterol demethylation mediated by fungal cytochrome P450 and blocking the synthesis of ergosterol in fungal cell membranes. It has good antibacterial effects against pathogenic fungi such as Candida and Cryptococcus. Clinically, it is mainly used for the treatment of cryptococcal meningitis, invasive candidiasis, and mucosal candidiasis, and can also be used for the prevention of fungal infections in immunocompromised patients. The applicable population covers adults and children over 6 months of age, and it is a first-line basic drug for antifungal therapy.

At present, the global market size of antifungal drugs is growing steadily. Fluconazole, with its definite efficacy, high safety and affordable price, is a core variety for antifungal reserves in primary medical institutions and public health. Public data shows that in 2023, the domestic market size of fluconazole preparations was approximately RMB 1.8 billion, of which oral dosage forms accounted for 62% and injection dosage forms accounted for 38%. As the compound patent has expired for many years, domestic generic drug enterprises occupy a dominant position. More than 80 enterprises have had their fluconazole preparations passed the consistency evaluation. The selected price in the national centralized drug procurement has dropped by more than 90% at the highest compared with the original research drug, which has greatly improved clinical accessibility, and the terminal demand maintains a steady growth rate of around 3% per year.

The original research enterprise of fluconazole is Pfizer, with the trade name Diflucan®. Its core compound patent was first applied for in 1982, and the patents in major global markets expired around 2004. The main dosage forms approved for the original research drug include tablets (50mg, 100mg, 150mg, 200mg), capsules (50mg, 100mg, 150mg) and injections (2mg/ml, specifications 50ml, 100ml). The original research dosage forms have been included in the China Listed Drug Catalogue and are also included in the FDA Reference Listed Drug Catalogue. Up to now, there are more than 60 registration records of fluconazole API on the API registration platform of China CDE, among which 40 have been converted to A status, which can meet the domestic production demand of preparations; the domestically approved fluconazole preparation varieties cover all mainstream dosage forms such as oral regular-release dosage forms and injections. (Data as of July 2025, please refer to the official website of CDE for the latest information)

In response to the demand for quality research and compliant production of this variety, CATO can provide a full set of fluconazole impurity reference standards, covering all test items such as related substances and residual solvents. Most products are in stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, which can effectively help pharmaceutical enterprises quickly complete quality research, declaration and registration, as well as daily release testing, and reduce compliance risks.