Mebendazole

As a classic representative of broad-spectrum anthelmintic drugs, mebendazole belongs to the benzimidazole class of antiparasitic drugs. By inhibiting the polymerization of microtubules in the intestinal wall cells of parasites, it blocks their uptake of nutrients such as glucose, promotes the depletion of glycogen in the worms, and ultimately makes them unable to survive and reproduce. This drug has a killing effect on a variety of intestinal parasites such as roundworm, pinworm, whipworm, hookworm, *Strongyloides stercoralis*, and tapeworm. It is applicable to both children and adults, and is a first-line drug recommended by global parasitic disease prevention and control guidelines, especially playing a core role in mass parasitic disease prevention and control in areas where sanitary conditions need to be improved.

At present, the global market size of mebendazole preparations is approximately USD 320 million. Driven by the expanding demand for parasitic disease prevention and control in tropical and subtropical regions and the popularization of routine deworming screening for children, the compound annual growth rate in the past three years has remained at 4.8%. In the competitive landscape, generic drugs account for 87% of the overall market share, and the supply of active pharmaceutical ingredients (APIs) is mainly concentrated in China and India, which together account for more than 90% of the global production capacity. Among them, Chinese-made mebendazole APIs are the main procurement source for European and American generic drug companies due to their stable purity and high level of impurity control. In terms of the domestic market, this variety has been included in the National Essential Medicines List, and the demand for deworming drugs in primary medical institutions is stable.

The original research enterprise of mebendazole is Janssen Pharmaceuticals, and the original brand name is "Vermox". Its core compound patent expired globally in 1982, and there is no compound patent restriction in the main market at present. The original dosage form is oral tablet, with a conventional specification of 100 mg per tablet, which has been included in the *List of Chemical Reference Preparations* of China and the FDA Reference Preparations List. In terms of domestic API registration, as of now, 6 enterprises have obtained A status for their mebendazole APIs through CDE registration, which can be legally supplied to domestic preparation manufacturers; the domestically approved and marketed mebendazole preparations include two dosage forms, tablets and suspensions, covering both adult and pediatric medication scenarios. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for mebendazole API. Most products are in sufficient stock, and orders placed before 16:00 can be shipped on the same day. All products meet the quality control requirements under multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide full-process compliance support for pharmaceutical enterprises in API R&D, production and registration declaration.