Butenafine

Superficial mycosis is a highly prevalent infectious disease globally, among which conditions such as tinea corporis and cruris, tinea manuum and pedis are prone to recurrent attacks. Traditional antifungal drugs often have the problems of narrow bactericidal spectrum, long course of treatment and high recurrence rate. Butenafine is a third-generation topical antifungal drug of the benzylamine class. It specifically inhibits fungal squalene epoxidase, blocks the synthesis of ergosterol in fungal cell membranes, and at the same time causes the accumulation of squalene in cells, achieving rapid bactericidal effect through dual actions. Compared with azole antifungal drugs, it has stronger bacteriostatic activity and lower incidence of drug resistance. It is clinically mainly used for tinea manuum, tinea pedis, tinea corporis, tinea cruris and tinea versicolor caused by sensitive fungi, and can be used by adults and adolescents over 12 years old, with good safety for topical administration.

The global market size of topical antifungal drugs had exceeded 8.5 billion US dollars in 2023, among which allylamine and benzylamine drugs account for approximately 23%, with a compound annual growth rate maintained at 4.2%. In terms of the domestic market, the overall scale of butenafine preparations is approximately 720 million yuan, with a stable growth rate of 6.8% in the past three years. Currently, the market is dominated by generic drugs, and there are more than 12 manufacturers of approved topical preparations. After the implementation of centralized procurement, the product penetration rate continues to increase, driving the steady rise of demand for upstream API.

The original developer of butenafine is Hisamitsu Pharmaceutical Co., Inc. of Japan, with the original brand name "Mentax". Its core compound patent in the United States expired in 2008, and the Chinese compound patent has also expired. The main dosage form approved for the original drug is 1% butenafine hydrochloride cream, with specifications of 15g:0.15g and 30g:0.3g. It has been included in the FDA Reference Listed Drug Catalog, and also included in the China Catalog of Reference Preparations for Chemical Drugs. Up to now, 11 domestic enterprises have obtained CDE registration for butenafine hydrochloride API, all with the status of A. The approved preparation dosage forms cover cream, liniment, spray and other types. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of butenafine impurity reference standards. Most products are in stock. In-stock products ordered before 16:00 will be shipped on the same day. They comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use requirements in the stages of API R&D, quality research and registration, providing reliable support for enterprises' product R&D and compliant marketing.