Clotrimazole

In response to the clinical pain points of high incidence and high recurrence rate of superficial mycosis, imidazole antifungal drugs have become first-line treatment options with their broad-spectrum antifungal activity, and clotrimazole is one of the most widely used varieties among them. It inhibits the biosynthesis of ergosterol in fungal cell membranes, damages the structure of cell membranes and changes their permeability, ultimately leading to the leakage and death of important substances in fungal cells. Clotrimazole has a good inhibitory effect on Candida albicans, dermatophytes, cryptococcus and so on. In clinical practice, it can be used externally to treat superficial fungal infections such as tinea corporis and cruris, tinea manus and pedis, and candidal vulvovaginitis, and can also be taken orally for deep infections caused by sensitive bacteria. It covers multiple applicable groups including adults and children, and is an essential basic antifungal drug in the global primary medical system.

At present, the global market size of clotrimazole is approximately USD 1.28 billion, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 3.7%. The growth momentum mainly comes from the rising prevalence of dermatomycosis, the increasing recurrence rate of vaginal candidiasis, and the improvement of the accessibility of antifungal drugs in low-income countries. As the compound patent has long expired, the market is dominated by generic drugs. China and India are the core suppliers of clotrimazole API in the world, accounting for more than 85% of the global production capacity in total. In terms of the domestic market, clotrimazole preparations have been included in the National Essential Medicine List, and external dosage forms have been included in the centralized procurement scope of multiple provinces. The API cost is controllable, the downstream preparation market is fully competitive, and the clinical accessibility is relatively high.

The original research enterprise of clotrimazole is Bayer AG of Germany, with the original brand name "Canesten". Its core compound patent expired globally in 1981. The main dosage forms of the original research drug currently on the market include vaginal tablets (0.5g), creams (1%, 3%), solutions (1%), etc. Multiple dosage forms have been included in the Reference Listed Drug Catalogue of China NMPA and the Reference Listed Drug Catalogue of FDA. In terms of domestic API registration, more than 20 enterprises have obtained A-status registration numbers for their clotrimazole APIs after approval by CDE, and more than 300 clotrimazole-related preparation approvals have been granted for marketing in China, covering all common dosage forms such as external use and oral administration. (Data as of October 2024, please refer to the official website of CDE for the latest information)

As a professional supplier deeply engaged in the field of pharmaceutical reference standards, CATO can provide a full set of impurity reference standards for clotrimazole API. Most of the products are available in stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises for R&D, quality control and registration declaration.