Itraconazole

As the incidence of deep fungal infections continues to rise among immunocompromised populations, antifungal drugs with high efficacy and low toxicity have become a rigid clinical demand. Itraconazole is a triazole broad-spectrum antifungal drug, which exerts bacteriostatic activity by inhibiting the synthesis of ergosterol in fungal cell membranes. Its antibacterial spectrum covers a variety of pathogenic bacteria such as Candida, Aspergillus and Cryptococcus, and it can be used to treat dermatophyte infections, onychomycosis, systemic fungal infections, etc. The applicable population includes patients with normal immune function and immunodeficient patients with underlying diseases, making it one of the core drugs for clinical stepwise antifungal therapy.

In recent years, the global market size of itraconazole has stabilized at around USD 1.2 billion. Driven by the popularization of immunosuppressant use and the growing demand for antifungal prophylaxis, the compound annual growth rate has remained at 3.7%. In the domestic market, original research drugs and generic drugs currently coexist, with original research products still accounting for about 45% of the market share. After the implementation of centralized procurement, the price drop of generic drugs has driven the increase of the overall medication penetration rate. In 2023, the terminal sales of itraconazole in domestic public medical institutions exceeded RMB 2.2 billion. At present, the core patents of this drug have expired, the number of applications from local generic pharmaceutical enterprises is growing rapidly, and the demand for the compliance of impurity reference substances continues to be released.

CATO can provide a full set of impurity reference standards for itraconazole API. All products meet the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, with sufficient in-stock reserves, which can directly respond to the reference substance use demands of pharmaceutical enterprises in the whole process of R&D, quality research and production, help customers efficiently complete compliance verification and shorten the product launch cycle.