Oxiconazole

Superficial fungal infection is an infectious disease with a high incidence worldwide. Common diseases such as tinea manus and pedis, tinea corporis and cruris, and vaginal candidiasis recur repeatedly, causing long-term distress to patients' quality of life. Oxiconazole is an imidazole antifungal API. It inhibits the synthesis of ergosterol in the fungal cell membrane to destroy the structural integrity of the cell membrane. Meanwhile, it can also affect the activities of oxidase and peroxidase in fungal cells, leading to the accumulation of intracellular peroxides, and finally exert a broad-spectrum bacteriostatic and bactericidal effect. It has strong activity against a variety of pathogenic bacteria such as Trichophyton rubrum and Candida albicans, and is suitable for the preparation of related preparations for people with superficial fungal infection of all ages who have no history of imidazole drug allergy.

At present, the global market size of topical antifungal preparations has exceeded 13 billion US dollars. Among them, imidazole drugs account for more than 35% of the market share of topical antifungal drugs by virtue of their high safety and cost performance. As the third generation of imidazole antifungal drugs, oxiconazole has the advantages of strong drug penetration, long-lasting effect and low recurrence rate, so its annual growth rate of market demand remains at about 7.2%. At present, a number of generic pharmaceutical enterprises around the world have laid out related preparations. There is no original research product launched in the domestic market, the generic drug declaration progress of local pharmaceutical enterprises is gradually accelerating, and the demand for localization of corresponding APIs continues to rise.

The original research enterprise of oxiconazole is Ferrer Internacional, Spain, and the trade name of its original research topical cream is Oceral. The core compound patent has expired globally in 2012. At present, the main dosage form approved by the original research is 1% cream, which has been included in the FDA reference preparation catalog. There is no import approval record of oxiconazole original research preparations in China. As of the retrieval time point, there is no approved oxiconazole registration number with A status in the CDE API registration database, nor is there any oxiconazole preparation variety approved by domestic enterprises. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the current R&D and declaration needs of oxiconazole, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can meet the full-process research needs of pharmaceutical enterprises from prescription process development to registration and declaration.