Hydralazine

As a chronic cardiovascular disease with a continuously rising prevalence rate, the clinical value of direct vasodilators in its treatment regimen has always been irreplaceable. Hydralazine is a thiazide derivative, which acts directly on arterial vascular smooth muscle, reduces calcium ion influx and thus lowers peripheral vascular resistance, while it does not affect venous vessels. While lowering blood pressure, it can reflexively excite the sympathetic nerve and increase renal blood flow. It is mostly used in the combination therapy of moderate and severe hypertension in clinical practice, especially suitable for patients with renal hypertension and high diastolic blood pressure. It is also often used in combination with nitrates for the long-term maintenance treatment of heart failure, and is one of the commonly used drugs for hypertension chronic disease management in primary medical institutions.

At present, the global market size of hydralazine preparations is approximately USD 420 million, with a compound annual growth rate of 3.1% in the past three years. The growth momentum mainly comes from the rising prevalence of hypertension in developing countries and the release of demand for chronic disease management among the elderly. In terms of the domestic market, the oral regular-release dosage forms of hydralazine have been included in the National Essential Medicines List and the Class A Medical Insurance Catalog, with strong rigid clinical demand. In 2023, the terminal sales of domestic public medical institutions exceeded RMB 110 million. The overall supply is dominated by generic drugs, and no original research product has been launched in China yet. On the API side, 3 domestic enterprises have obtained registration numbers at present, and the market competition pattern is relatively stable.

The original research enterprise of hydralazine is Novartis, with the original trade name Apresoline, which was first approved for marketing in the United States in 1953, and the core compound patent has expired globally. The original dosage forms include 10mg, 25mg, 50mg, 100mg oral tablets, as well as 20mg/1mL injection. Its oral tablets have been included in the FDA Reference Listed Drug Catalog. In China, there are currently 6 generic hydralazine for injection and 3 generic hydralazine tablets approved for marketing. The API registration platform shows that there are 3 domestic A-status registration numbers, and no original research API has submitted a registration application in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of hydralazine, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in the whole process of API declaration, preparation quality research, stability study, etc.