Voriconazole

Invasive fungal infection is one of the leading causes of death in immunocompromised populations. As a second-generation triazole antifungal drug, voriconazole exerts broad-spectrum antifungal activity by inhibiting 14α-sterol demethylation mediated by fungal cytochrome P450 and blocking the synthesis of ergosterol in fungal cell membranes. It has potent inhibitory effects on Aspergillus, Candida, Cryptococcus and rare filamentous fungi. It is the first-line drug for clinical treatment of invasive aspergillosis, and can also be used for severe Candida infections resistant to fluconazole, and severe infections caused by Scedosporium and Fusarium. It is mainly used for immunodeficient patients in departments such as hematology, transplantation, and ICU, and has an irreplaceable clinical position.

At present, the global market size of voriconazole is stably above 1.2 billion US dollars, and the annual sales volume in the Chinese market exceeds 3 billion yuan, with a compound annual growth rate of 4.2% in the past three years, making it the single product with the largest share in the antifungal field. The domestic market has formed a pattern where the original research drug and generic drugs coexist. After the implementation of centralized drug procurement, the price of generic drugs has dropped by more than 70%, promoting the continuous increase of clinical penetration rate, and the demand for upstream API has increased steadily accordingly. At this stage, the annual domestic demand for voriconazole API has exceeded 150 tons.

The original research enterprise of voriconazole is Pfizer, with the trade name "Vfend". The core compound patents of the drug expire in 2015, 2016 and 2017 in the United States, Europe and China respectively. The main dosage forms approved for the original research drug include injection (200mg), oral dry suspension (40mg/ml) and tablets (50mg, 200mg), which have been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA Reference Preparation Catalogue. Up to now, 19 registration numbers of voriconazole API have been publicized on the platform of China CDE, among which 11 are in status A, and more than 30 domestic enterprises have been approved for voriconazole oral and injection preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for voriconazole API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises in all links of API research and development, quality research and compliance declaration.