氢氯噻嗪

Hypertension is one of the chronic cardiovascular diseases with the highest prevalence in the world. As first-line antihypertensive drugs, diuretics have long been the core component of combined antihypertensive regimens. Hydrochlorothiazide is a thiazide intermediate-acting diuretic. It inhibits the reabsorption of sodium and chloride in the cortical part of the thick ascending limb of the renal medullary loop, increases the excretion of water and sodium to reduce blood volume, and at the same time reduces the responsiveness of vascular smooth muscle to vasoconstrictor substances, exerting a stable antihypertensive effect. In clinical practice, in addition to being used alone or in combination with other antihypertensive drugs to treat various types of hypertension, it can also be used for edematous diseases caused by congestive heart failure, cirrhotic ascites, nephrotic syndrome, etc. The applicable population covers adult hypertensive patients and people with related diseases who need to improve water and sodium retention. It is also the core component of a variety of compound antihypertensive preparations.

At present, the global market size of hydrochlorothiazide is stable at around 500 million US dollars. As a classic drug that has been on the market for more than 60 years, its market growth mainly comes from the expansion of demand for compound antihypertensive preparations, and the growth rate has remained at 3%~5% in recent years. In terms of the domestic market, the overall size of hydrochlorothiazide preparations is about 800 million yuan. Among them, the price of single-agent preparations has dropped significantly due to the impact of centralized procurement, and compound preparations account for more than 65%. The competitive landscape is dominated by generic drugs. Domestic API manufacturers are concentrated in North China and East China. The top 3 enterprises have a market share of more than 70%. Production cost control and supply chain stability are the core competitive factors, and there is no latest verifiable segmented market share data.

The original research enterprise of hydrochlorothiazide is Novartis, and the original research trade name is HydroDIURIL. The core compound patent expired globally around 1970. At present, the main marketed dosage form is tablet, and the common specifications include 25mg and 50mg. The original research product has been included in the FDA Reference Listed Drug Catalog, and is included in Volume II of the Chinese Pharmacopoeia 2020 Edition in China. Up to now, more than 30 domestic enterprises have completed the registration of hydrochlorothiazide APIs at CDE and obtained A status, and there are more than 100 approvals for marketed single-agent preparations and compound preparations containing hydrochlorothiazide. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for hydrochlorothiazide. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the needs of various scenarios such as API R&D, quality research and routine quality control testing.