Bifonazole

Skin fungal infection is a highly prevalent infectious disease worldwide. Among them, the prevalence of superficial mycosis such as tinea manuum and pedis, tinea corporis and cruris, and tinea versicolor is as high as 20%-30%, and the high recurrence rate is the core pain point in clinical treatment. Bifonazole is an imidazole broad-spectrum antifungal drug. It destroys the structural integrity of fungal cell membranes by inhibiting the synthesis of ergosterol in the membranes. It has both bacteriostatic and bactericidal dual activities, and exerts strong effects on a variety of pathogenic fungi such as dermatophytes, yeasts and molds. Compared with similar drugs, it has higher skin penetration depth and longer duration of action. Only once-daily administration is required to maintain effective therapeutic concentration, which can significantly improve patients' medication compliance, and it is currently the first-line recommended drug for the treatment of superficial fungal infections.

At present, the global market size of bifonazole is approximately USD 420 million, with a compound annual growth rate maintained at around 3.8%. The growth momentum mainly comes from the release of demand for dermatological drugs at the primary care level and the expansion of the OTC market. In terms of the domestic market, the sales volume of bifonazole preparations at public hospital terminals in 2023 was approximately RMB 370 million, and the sales volume at retail terminals exceeded RMB 500 million, with an overall growth rate of 6.2%. The competitive landscape is dominated by generic drugs, with the original research product accounting for less than 20% of the market. Domestic API manufacturers are concentrated in Jiangsu, Zhejiang, Guangdong and other regions, and more than 15 enterprises have obtained API production approvals, with a mature supply system and prominent cost advantages.

The original research enterprise of bifonazole is Bayer Pharma, and the original brand name is "Meike". Its core compound patent expired globally in 2003. At present, the dosage form of the original research product approved in China is mainly 1% bifonazole cream, with the specification of 10g:0.1g. This dosage form has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration, and is also listed as a reference preparation by the FDA. In terms of domestic API registration, there are currently 12 activated registration numbers for bifonazole APIs. The approved preparation varieties cover multiple dosage forms such as cream, solution, gel and spray, which can fully meet the use needs of different clinical scenarios. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for bifonazole API, covering all types such as process impurities and degradation impurities. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can directly support the registration declaration, quality research and routine release testing needs of APIs.