Amorolfine

Superficial fungal diseases such as onychomycosis and cutaneous fungal infections have long been common clinical challenges in dermatology due to their high recurrence rate and long treatment cycle. Amorolfine is a morpholine antifungal drug. It exerts broad-spectrum bacteriostatic and bactericidal effects by inhibiting the biosynthesis of ergosterol in fungal cell membranes, altering the permeability and function of cell membranes, and damaging fungal cell walls at the same time. It has high activity against common pathogenic fungi such as dermatophytes, Candida and molds. In clinical practice, its external preparations are mostly used for the treatment of finger (toe) nail onychomycosis, tinea corporis and cruris, and tinea manus and pedis, and the applicable population covers patients with superficial fungal diseases without systemic infection. Due to the extremely low systemic absorption of local administration, it has excellent safety performance.

At present, the global market size of topical antifungal drugs is growing steadily. Among them, amorolfine has a global market compound annual growth rate of 4.2% in the past five years due to its better compliance than oral drugs in the treatment of onychomycosis, and the total market size of related preparations and active pharmaceutical ingredients (APIs) exceeded 380 million US dollars in 2023. From the perspective of the domestic market, after the implementation of the centralized procurement of topical antifungal drugs, the terminal price of amorolfine preparations has dropped by more than 60%, and the penetration rate in the primary market has increased rapidly. In 2023, the domestic demand for its API increased by 27% year-on-year. At present, the domestic supply of amorolfine API is dominated by generic pharmaceutical enterprises, with the original drug accounting for less than 15% of the market. With the expansion of indications to the field of gynecological fungal infections, the demand for API will still maintain an annual growth rate of more than 20% in the next three years.

The original research enterprise of amorolfine is Galderma France, and the trade name of its original topical preparation is "Loceryl". Its core compound patent expired globally in 2010, and the preparation process patent in China also expired in 2021. The main dosage forms of the original marketed products include amorolfine hydrochloride liniment (5%, 2.5ml/bottle) and amorolfine hydrochloride cream (0.25%, 20g/tube). Both products have been included in the *Catalogue of Chemical Reference Preparations* of China, and are also reference preparations recognized by the FDA. Up to now, 11 domestic enterprises have obtained A status for their amorolfine hydrochloride APIs through CDE registration, and another 3 are under review. The amorolfine preparations approved for marketing in China involve two dosage forms: liniment and cream, with a total of 24 approved approval numbers. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for amorolfine, covering all categories such as synthetic impurities, degradation impurities and enantiomers. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of the whole process of API R&D, quality research and declaration.