Miconazole

Fungal infection is a highly prevalent infectious disease globally. Superficial fungal infections affect more than 25% of the population, while the mortality rate of deep fungal infections is as high as over 30%. There is a long-term clinical demand for safe and effective broad-spectrum antifungal drugs. Miconazole is an imidazole antifungal drug. It inhibits the biosynthesis of ergosterol in fungal cell membranes, damages the cell membrane and changes its permeability. Meanwhile, it inhibits the activity of fungal oxidase and peroxidase, leading to the accumulation of intracellular hydrogen peroxide, and ultimately promoting fungal necrosis. This drug has strong activity against Candida, dermatophytes, Cryptococcus and some Gram-positive bacteria, and can be used for the treatment of mucocutaneous fungal infections, vaginal candidiasis and systemic fungal infections, covering both adult and pediatric populations.

The global market size of miconazole is stable at around USD 1.2 billion, with a steady compound annual growth rate of 2.3%, among which topical preparations account for more than 75% of the overall market share. In terms of the domestic market, miconazole topical preparations are commonly used drugs in the dermatology and gynecology departments of public medical institutions. In 2023, its sales in hospitals exceeded RMB 1.8 billion, and sales in OTC channels even exceeded RMB 2.7 billion. Due to its early launch time, the current domestic miconazole preparation market is dominated by generic drugs, with more than 40 manufacturers. The supply of API has been localized, and only a small number of high-end dosage forms use imported API. The overall market competition is sufficient, and the price is within a reasonable range.

The original research enterprise of miconazole is Johnson & Johnson of the United States. The trade name of its original research topical preparation is "Daktarin", and the trade name of its oral preparation is "Monistat". Its core compound patent expired globally as early as 1979, and subsequent peripheral dosage form patents also all expired before 2005. At present, the dosage forms approved by the original research in China include miconazole nitrate cream (2%, 20g/branch), miconazole nitrate vaginal soft capsule (0.4g/pill), etc. All relevant dosage forms have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. Up to now, 32 domestic enterprises have obtained Class A status for their miconazole nitrate API through CDE registration, and more than 50 related generic preparations have been approved for marketing, covering multiple dosage forms such as cream, suppository, powder and injection. (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 miconazole API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the full-process needs of API R&D, quality research and declaration.