Ivermectin

Parasitic infection is a long-term challenge in the global public health field, especially in tropical and subtropical regions. Vector-borne diseases such as onchocerciasis and lymphatic filariasis have long threatened the health of low-income groups. Ivermectin, a derivative of the avermectin family, is a macrolide antiparasitic drug. It non-selectively opens the glutamate-gated chloride channels of parasites, causing nerve paralysis and death of the parasites, and has both broad-spectrum antiparasitic activity and high safety. In addition to the indications for human use against nematode and ectoparasite infections, this drug is also widely used in the prevention and control of parasitic diseases in the livestock, poultry and aquaculture fields, and is one of the core varieties in the global anthelmintic drug system.

The global ivermectin market size was approximately USD 2.18 billion in 2023, and the compound annual growth rate is expected to remain at around 4.6% by 2028. The growth drivers mainly come from the expansion of parasite prevention and control demand in tropical regions and the steady increase in usage in the veterinary field. At present, the global production capacity is mainly concentrated in China and India. Domestic enterprises, relying on the advantage of raw material cost, account for more than 60% of the global API supply share. The human preparation market presents a competitive landscape where the original research enterprise takes the lead and generic drug enterprises participate in the supply of the primary market. After the implementation of centralized procurement, the terminal price of human ivermectin preparations has dropped by more than 70% compared with the original research product, and the accessibility has been greatly improved.

The original research enterprise of ivermectin is Merck & Co., Inc., and the original trade name is "Mectizan". Its core compound patent expired globally in 1999. At present, the main dosage forms approved by the original research include tablets and creams. The human tablet has a specification of 3mg, which has been included in the *Catalogue of Chemical Reference Preparations* issued by the National Medical Products Administration (NMPA) of China, and is also listed in the FDA reference preparation catalogue. According to the domestic API registration platform, more than 30 enterprises have obtained A-status registration numbers for their ivermectin APIs, and more than 20 domestic generic drug approvals for human preparations have been launched, which can fully meet domestic clinical and export demands. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of ivermectin impurity reference standards. Its products cover all categories of pharmacopeial impurities, process impurities and degradation impurities, which can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia, FDA and ICH. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day, which can provide stable reference material support for the whole process of API R&D, quality research and registration.