Ketoconazole

Superficial fungal infection is an infectious disease with a high incidence worldwide. According to statistics, the annual number of cases exceeds 1 billion person-times. As a classic variety of imidazole antifungal drugs, ketoconazole exerts broad-spectrum antifungal activity by inhibiting the biosynthesis of ergosterol in fungal cell membranes, damaging the structure of cell membranes and changing their permeability. It has a strong inhibitory effect on dermatophytes, yeasts and dimorphic fungi. Clinically, it can be used for the local treatment of superficial fungal infections such as tinea manuum, tinea pedis, tinea corporis and cruris, tinea versicolor, and cutaneous candidiasis. It can also be used for the treatment of systemic fungal infections under the premise of strict liver function monitoring, and the applicable population covers adults and children without medication contraindications.

The global market size of ketoconazole preparations is approximately USD 870 million, with a compound annual growth rate maintained at around 2.3%, among which topical preparations account for 89% of the overall market share. At present, domestic generic drug enterprises are the main suppliers in the ketoconazole preparation market, with more than 200 relevant approval numbers. Common dosage forms such as topical creams and lotions have been included in multiple batches of national centralized drug procurement, and the winning bid price has dropped by more than 70% compared with the original research product, further improving the accessibility of primary medical medication. In terms of API, domestic production capacity is sufficient, and China is the main exporter of ketoconazole API in the world, with annual export volume accounting for about 62% of the global trade volume.

The original research enterprise of ketoconazole is Janssen Pharmaceutica of Belgium, with the original brand name "Nizoral". Its core compound patent expired globally in 1999. At present, the main dosage forms of the original research product approved worldwide include oral tablets (200mg), topical cream (2%) and lotion (2%), all of which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, 11 domestic enterprises have obtained A-status registration numbers for their ketoconazole APIs, and the approved and marketed preparations cover all common dosage forms such as creams, lotions, suppositories and oral tablets. (Data as of November 2024, please refer to the official website of CDE for the latest information)

In response to the needs of ketoconazole API quality research and preparation declaration, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D needs such as impurity qualitative and quantitative research and stability investigation.