Sertaconazole

Superficial fungal infection is one of the most prevalent disease types in dermatology. Due to its high recurrence rate and protracted course of disease, the clinical demand for broad-spectrum antifungal drugs with low drug resistance continues to rise. Sertaconazole is a new type of imidazole antifungal drug. It destroys the structure and function of fungal cell membranes by inhibiting the synthesis of ergosterol in the cell membranes, and also has direct anti-inflammatory activity. It has a potent killing effect on dermatophytes, yeasts, molds and some gram-positive bacteria. Clinically, it is mainly used for the treatment of tinea manus and pedis, tinea corporis and cruris, pityriasis versicolor, candidal vulvovaginitis and other diseases. When administered locally, the skin absorption amount is extremely low, and the systemic exposure risk is small. The applicable population covers adults and pediatric patients without skin ulceration, and it is a first-line topical treatment option for superficial fungal infections.

At present, the global market size of topical antifungal drugs has exceeded 8.5 billion US dollars, among which imidazole drugs account for more than 40%. With higher fungal clearance rate and lower recurrence rate, sertaconazole has maintained a market growth rate of 7.2% in recent years, which is higher than the average level of similar topical antifungal drugs. In terms of the domestic market, sertaconazole preparations have been included in the local medical insurance catalogs of many provinces. With the extension of the centralized procurement policy to topical preparations, the generic drug substitution process has been accelerating. In 2023, the domestic sales of sertaconazole preparations exceeded 470 million yuan, and the corresponding annual growth rate of API demand exceeded 12%. At present, 3 domestic enterprises have obtained API registration numbers, and the competition pattern on the supply side is relatively concentrated.

The original research enterprise of sertaconazole is Ferrer Internacional in Spain, with the original research brand name "Lamisil Once" (brand name "Zalain" in some markets). Its core compound patent expired in Europe in 2004, the core patent in the US market expired in 2005, and the compound patent in China expired in 1999. The originally marketed dosage forms are mainly 2% sertaconazole nitrate cream, 2% vaginal suppository and 1% spray. The 2% cream is available in 15g/tube and 30g/tube specifications, which has been included in the China List of Marketed Drugs as the reference preparation, and is also included in the FDA Reference Preparation Catalog. Up to now, there are 6 sertaconazole nitrate API registration numbers in China (including 3 in A status), and the domestically approved preparation varieties cover three categories: cream, suppository and gel. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the demand for quality research of sertaconazole API and preparations, CATO provides a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can effectively support enterprises in impurity research, quality standard establishment and declaration work, shortening the R&D cycle.