Terbinafine

Superficial fungal infections such as onychomycosis and dermatophytosis have long ranked among the top in terms of dermatology consultation volume. As a core representative of allylamine antifungal drugs, terbinafine specifically inhibits fungal squalene epoxidase to block the synthesis of ergosterol in fungal cell membranes, while causing the accumulation of squalene in fungal cells. The dual effects achieve a bactericidal effect, and meanwhile, it has minimal impact on the human cytochrome P450 enzyme system, with prominent safety advantages. The oral formulation of this drug is suitable for the treatment of tinea unguium, tinea capitis, severe tinea corporis and cruris, and tinea pedis and manuum, while the topical formulation can cover local intervention for various superficial fungal infections, making it a first-line choice for antifungal treatment in adults and children.

In recent years, the global market size of terbinafine has stabilized at around USD 1.2 billion, with a compound annual growth rate of 3.2%. Driven by the increased prevalence of superficial fungal infections and the expansion of medical insurance coverage, the growth rate in emerging markets can reach 5.8%. In terms of the domestic market, with the implementation of centralized procurement in multiple regions since 2018, the price of oral terbinafine tablets has dropped by more than 70%, and its clinical accessibility has been greatly improved. In 2023, the terminal sales of domestic public medical institutions exceeded RMB 800 million. At present, there are more than 70 approved approval numbers for terbinafine preparations in China, and the supply of APIs is dominated by local enterprises, with a relatively fragmented competitive landscape.

The original research enterprise of terbinafine is Novartis Pharmaceuticals, with the original brand name "Lamisil". Its core compound patent expired globally in 2003. The originally marketed formulations include 250mg oral tablets, 1% cream, 1% spray and 1% gel, among which the 250mg tablets and 1% cream have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also included in the FDA Reference Preparation Catalogue. Up to now, 15 registration entries of terbinafine API have been published on the API Registration Platform of China Center for Drug Evaluation (CDE), among which 11 are in status A (approved for use in marketed preparations). Multiple oral and topical terbinafine formulations have been approved for marketing in China. (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 terbinafine, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API R&D, quality control and consistency evaluation work.