Indapamide

For the long-term control of essential hypertension, the clinical practice always requires safe drugs with both hypotensive effect and cardiovascular protective effect, and indapamide is exactly one of the core options in such treatment regimens. As a sulfonamide thiazide-like diuretic, it increases the excretion of urinary sodium and chloride ions by inhibiting the reabsorption of sodium in the diluting segment of the renal cortex. Meanwhile, it can regulate the calcium ion transport of vascular smooth muscle and dilate peripheral blood vessels, with dual mechanisms of diuresis and vasodilation. Its hypotensive effect is stable and long-lasting. It can effectively control mild to moderate hypertension when used alone, and can also be combined with other hypotensive drugs to treat refractory hypertension. It can also improve the symptoms of water and sodium retention in patients with chronic heart failure, and its applicable population covers most adult hypertension patients. Long-term use has little impact on glucose and lipid metabolism, and clinical compliance is relatively high.

The prevalence rate of hypertension in China has reached 27.5%, with a patient base exceeding 300 million. As a basic medication for hypertension, indapamide has a long-term stable market demand. Data show that in recent years, the annual market size of domestic indapamide preparations has remained in the range of 800 million to 1 billion yuan, with an annual growth rate of 3%-5%. Currently, the market is dominated by generic drugs. More than 30 generic drug enterprises have passed the consistency evaluation for oral immediate-release dosage forms, and more than 15 enterprises have passed the consistency evaluation for sustained-release dosage forms. After the implementation of volume-based procurement, the prices of preparations have dropped significantly, and the supply demand for upstream APIs continues to release. Domestic API manufacturers are mainly local enterprises, and the overall supply pattern is stable.

The original research enterprise of indapamide is Servier in France, and the original research trade name is "Natrilix". Its core compound patent expired in 1993, and the patents related to sustained-release dosage forms expired around 2007. The dosage forms of the original research drug approved in China include 2.5mg conventional tablets and 1.5mg sustained-release tablets. Both dosage forms have been included in the China Listed Medicines Catalogue as reference preparations, and are also included in the FDA Reference Preparations Catalogue. Up to now, there have been more than 40 indapamide API registration information entries on the domestic CDE API Registration Platform, most of which are in "A" status and can be directly associated with preparation declaration. The domestically approved indapamide preparation varieties cover multiple dosage forms such as conventional tablets, sustained-release tablets and sustained-release capsules. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for indapamide. Most of the 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 regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet various application needs of pharmaceutical enterprises in R&D, quality research and routine quality control.