Tolnaftate

Superficial fungal infection is one of the most prevalent disease types in dermatology. Due to the diversity of pathogens and high recurrence rate, there has been a long-term clinical demand for safe and effective topical antifungal drugs. Tolnaftate is an antifungal active pharmaceutical ingredient (API) of thiocarbamate class. It exerts bacteriostatic effect by inhibiting the activity of fungal squalene epoxidase, blocking the ergosterol synthesis pathway, and destroying the structure of fungal cell membrane. It is highly sensitive to common pathogenic dermatophytes such as Trichophyton, Microsporum and Epidermophyton, and has no obvious hepatorenal toxicity. It is mainly used for the topical treatment of superficial fungal infections such as tinea manus and pedis, tinea corporis and cruris, and tinea versicolor, and is suitable for populations intolerant to oral antifungal drugs such as children and elderly patients.

At present, the global market size of tolnaftate is approximately USD 120 million, with a compound annual growth rate maintained at 3.8% in the past three years. The demand growth mainly comes from the expansion of the dermatological drug market in tropical regions such as Southeast Asia and Latin America. The domestic market size is approximately RMB 86 million. At the current stage, the competitive landscape is dominated by generic drug manufacturers. As the original research patent expired early, multiple domestic enterprises have obtained approval for preparations, and the localization rate of API supply exceeds 90%. Tolnaftate has not been included in the national centralized volume procurement catalog yet, so the market price remains relatively stable.

The original research enterprise of tolnaftate is Johnson & Johnson Japan, with the original brand name Tinaderm. The core compound patent expired globally in 1989, and there is no core patent restriction at present. The main dosage forms approved for the original product are 1% cream and 1% powder, among which the 1% cream has been included in the FDA Reference Listed Drug Catalog, but has not been included in the Chinese *Catalog of Reference Preparations for Chemical Drugs* yet. According to the information on the domestic API registration platform, 6 enterprises have obtained A-status registration numbers for tolnaftate APIs so far, and the domestically approved preparation varieties are mainly creams and solutions. (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 tolnaftate API. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of different scenarios such as API R&D, quality research, and declaration and registration.