Fenticonazole

Fungal infections have always been a high-incidence disease type in the field of skin and mucosal diseases, especially vulvovaginal candidiasis, tinea corporis and cruris and other conditions, which often recur due to incomplete medication or fungal drug resistance. Fenticonazole is an imidazole class broad-spectrum antifungal active pharmaceutical ingredient. It destroys the structure and function of fungal cell membrane by inhibiting the synthesis of ergosterol in fungal cell membrane, and also has certain inhibitory activity against Gram-positive bacteria. In clinical practice, its preparations are mostly used for the treatment of dermatomycosis and vulvovaginal candidiasis, and the applicable population covers patients with skin and mucosal infections caused by various sensitive bacteria. Compared with similar imidazole drugs, it has longer skin retention time after local administration, less systemic absorption, and more advantages in safety.

In the global antifungal drug market, topical antifungal preparations account for about 35%. As a commonly used active pharmaceutical ingredient for topical antifungal use, fenticonazole has maintained a market compound annual growth rate of about 4.2% in the past 5 years, and the current global annual demand is stable at around 120 tons. In the domestic market, imported preparations have dominated the supply for a long time. With the advancement of generic drug research and development, local active pharmaceutical ingredient enterprises have gradually deployed production capacity. At present, 3 local enterprises have submitted marketing registration applications for active pharmaceutical ingredients, and there is sufficient space for generic drug substitution. There is no publicly verifiable accurate data on market size and patent expiration.

The original research enterprise of fenticonazole is Recordati S.p.A, an Italian company, with the original brand name Lomexin. Its main dosage forms include vaginal soft capsules, cream and spray, and the common specifications are 2% cream, 100mg vaginal soft capsule and 200mg vaginal soft capsule. The original research preparation has been included in the FDA Reference Listed Drug Catalogue. No original research preparation has been marketed in China, and 2 domestic fenticonazole creams have been approved for marketing. There are currently 3 active pharmaceutical ingredient registration information on the active pharmaceutical ingredient registration platform, all of which are declared by domestic enterprises, with the status of A (already used in marketed preparations) and I (under review and approval). (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for fenticonazole API. The vast majority of products have sufficient spot inventory. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmacopoeias and regulatory regulations of multiple countries such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of quality research, impurity control and registration declaration in the process of research and development and production, helping relevant enterprises shorten the research and development cycle and ensure compliance.