Nitazoxanide

Parasitic infections have long plagued the primary public health systems in tropical and subtropical regions. Traditional antiparasitic drugs generally face the pain points of increasing drug resistance and limited indication coverage. Nitazoxanide is a thiazole-class broad-spectrum antiparasitic drug. It blocks the energy metabolism process of pathogens by inhibiting the activity of pyruvate ferredoxin oxidoreductase. It not only has a significant killing effect on intestinal parasites such as Cryptosporidium and Giardia lamblia, but also has inhibitory activity against hepatitis B virus, hepatitis C virus and some anaerobic bacteria. It can be used for the treatment of intestinal parasitic infections in adults and children, and meanwhile has an irreplaceable clinical position in the treatment of cryptosporidiosis in immunocompromised patients.

The global nitazoxanide market size has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 320 million, with a compound annual growth rate maintained at around 4.7%. The growth drivers mainly come from the increasing demand for parasitic disease prevention and control in emerging markets, as well as the clinical exploration of its new antiviral-related indications. The current market competition is dominated by generic drugs. India and China are the world's most important suppliers of nitazoxanide API, accounting for 78% of the global API supply share in total. As patents in many regions expire successively, the substitution rate of generic drugs continues to rise, and the advancement of relevant domestic volume-based procurement policies has further compressed the market space of the original research products.

The original research enterprise of nitazoxanide is Romark Laboratories in the United States, and the original brand name is Alinia. The core compound patent expired in 2010. The main dosage forms approved for the original research product include tablets (500mg) and oral suspension (100mg/5ml), which have been included in the FDA Reference Listed Drug Catalog, and are also included in the *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)* of China. At present, there are 12 domestic nitazoxanide API registration numbers, 8 of which are in status A and can be used in association with marketed drugs. Domestic generic nitazoxanide tablets and capsules have already been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

From the impurity qualitative analysis in the R&D stage to the quality compliance control in the production link, CATO can provide a full set of nitazoxanide impurity reference standards. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the quality control needs of pharmaceutical enterprises in the whole process of R&D and production.