Azintamide

For patients with digestive dysfunction, symptoms such as postprandial abdominal distension, belching and fat indigestion often significantly reduce their quality of life, while azintamide is a commonly used compound component in the treatment of such diseases. As a pancreatic enzyme supplement and a bile secretion-promoting drug, it directly supplements amylase, protease and lipase to improve the digestive capacity of the gastrointestinal tract, and at the same time promotes bile secretion to increase the efficiency of fat emulsification. It is often formulated into compound preparations with dimethicone and digestive enzymes for the treatment of indigestion caused by insufficient bile secretion and digestive enzyme deficiency. It is also applicable to the improvement of digestive function in patients with chronic cholecystitis and after cholecystectomy, covering adult patients of all age groups, and the elderly population with declining hepato-pancreatic function benefits particularly significantly.

At present, the domestic market size related to azintamide is about 1.2 billion yuan, and the compound growth rate in the past three years has remained at 6.8%. The demand growth mainly comes from the increase in the consultation rate of chronic digestive tract diseases and the expansion of the elderly population base. The competition pattern shows a trend of original research leading and generic drugs following up rapidly. There are 7 approvals for the marketed compound azintamide preparations in total, among which the original research product accounts for about 58% of the market share, and the total market share of 3 domestic generic drug enterprises exceeds 40%. There is no national centralized procurement record so far. The API suppliers are mainly domestic compliant chemical pharmaceutical enterprises and imported manufacturers, and there is no publicly verifiable global market size data.

The original research enterprise of azintamide is Il-Yang Pharmaceutical Co., Ltd. of South Korea, and the original research trade name is "Mite". Its core compound patent expired globally in 2017. At present, the main dosage form marketed in China is compound azintamide enteric-coated tablets, with the conventional specification of 75mg azintamide per tablet. This original research product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. At present, 6 domestic enterprises have completed the registration of azintamide APIs in CDE and activated the A status, corresponding to a total of 7 approval numbers for the marketed compound azintamide preparations. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full range of azintamide impurity reference standards, covering all key impurities in the synthetic route and degradation pathway. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and fully meet various compliance needs of API R&D, quality research and routine release testing.