Crotamiton

Cutaneous parasitic infections such as scabies and pubic lice are common infectious diseases in dermatology, with an annual global incidence of over 200 million person-times. Traditional sulfur-based therapeutic drugs have the shortcomings of strong irritation and poor compliance, while the clinical application of crotamiton has effectively filled this demand gap. As a broad-spectrum antiparasitic topical active pharmaceutical ingredient, crotamiton acts on the nervous system of parasites to paralyze and kill them, and also has a local anesthetic and antipruritic effect. It is mainly clinically used for the treatment of scabies in people of all age groups, and can also relieve skin itching symptoms caused by pubic lice disease, allergic dermatitis, etc. It is one of the first-line anti-scabies drugs recommended by the WHO.

The global crotamiton market size is stable at around USD 230 million, with a compound annual growth rate of approximately 3.2%, and the demand is mainly concentrated in two sectors: community health prevention and control, and OTC dermatological drugs. In terms of the domestic market, with the improvement of the primary dermatology diagnosis and treatment system, the annual growth rate of crotamiton preparation sales has maintained above 7% in the past 3 years. At present, the supply of active pharmaceutical ingredients is dominated by domestic manufacturers, with an import substitution rate of more than 90%, there is no centralized procurement bid record, and the supply chain demand of downstream preparation manufacturers is relatively stable.

The original research enterprise of crotamiton is Bayer AG of Germany, with the original brand name Eurax. The core compound patent expired globally around 1970. At present, the mainstream dosage form is 10% crotamiton cream, with two conventional specifications: 10g:1g and 30g:3g. The original research cream has been included in the FDA Reference Listed Drug Catalog, but has not been included in the China Listed Drug Catalog. At present, a total of 5 domestic enterprises have obtained A-status registration numbers for crotamiton active pharmaceutical ingredients, and another 3 enterprises have obtained approval for the marketing of 10% crotamiton cream, and the supply can meet domestic clinical demand. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of crotamiton impurity reference standards. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most of the products have sufficient spot inventory. Spot orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard support for active pharmaceutical ingredient R&D, quality research and preparation consistency evaluation work.