Amiloride

In the clinical treatment of sodium and water retention diseases such as renal edema and heart failure, potassium-sparing diuretics are the core category of medications that balance diuretic effect and electrolyte stability. As a representative variety of low-efficacy potassium-sparing diuretics, amiloride specifically inhibits sodium channels in distal renal tubular epithelial cells, reduces sodium ion reabsorption and potassium ion excretion, and exerts diuretic effect without relying on aldosterone antagonism. Its clinical indications cover edema caused by congestive heart failure, cirrhotic ascites, nephrotic syndrome, etc. It can also be used in combination with potassium-excreting diuretics to correct hypokalemia, and is especially suitable for elderly patients and chronic kidney disease populations who require long-term diuresis and have a high risk of electrolyte disorders.

In the global diuretic market, amiloride has maintained stable market demand for a long time due to its clear clinical positioning and outstanding safety. Data shows that in 2023, the sales volume of amiloride preparations at the terminal of China's public medical institutions was approximately 120 million yuan, with a compound annual growth rate of 4.7% in the past three years. The demand growth mainly comes from the expansion of the chronic heart failure patient group. In terms of the competitive landscape, the domestic preparation market is dominated by generic drugs, and the production of active pharmaceutical ingredients (APIs) is concentrated in a small number of enterprises with stable synthesis processes. There is no winning record in centralized procurement so far, and the overall market competitive landscape is relatively loose.

The original research enterprise of amiloride is Merck & Co., Inc., with the original brand name Midamor. The core compound patent expired in 1990. The main dosage form approved for the original product is tablet, with a specification of 5mg. It has been included in the FDA Reference Listed Drug Catalog, and is also a reference listed drug collected in the China Listed Drug Catalog. According to the domestic API registration platform, 3 enterprises have obtained A-status registration numbers for amiloride APIs so far, and there are 12 domestic preparation approval documents in total, among which 8 varieties have passed the consistency evaluation. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of amiloride impurity reference standards, covering the full research chain requirements including synthetic starting materials, intermediates, degradation impurities, etc. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can effectively support pharmaceutical enterprises in impurity research, quality standard establishment and consistency evaluation work.