Nilvadipine

Hypertension is a chronic cardiovascular disease affecting more than 1.2 billion people worldwide. Long-term blood pressure control is the core intervention direction to reduce severe complications such as stroke and myocardial infarction. Nivaldipine is a second-generation dihydropyridine calcium channel blocker. It highly selectively blocks L-type calcium channels on the membrane of vascular smooth muscle cells, reduces calcium ion influx, and dilates peripheral arteries and coronary arteries. It has the clinical characteristics of stable antihypertensive effect and little impact on heart rate. It is mainly used clinically for the treatment of essential hypertension, especially suitable for elderly hypertensive patients with coronary heart disease and renal function impairment. It can achieve stable 24-hour blood pressure control and reduce target organ damage caused by blood pressure fluctuations.

The global market size of antihypertensive drugs has exceeded 35 billion US dollars. With definite efficacy and good tolerability, calcium channel blockers account for about 18% of the overall antihypertensive drug market. As a representative variety of highly selective calcium channel blockers, the current nivaldipine market is still dominated by generic drug supply. Japan and China are the world's main producers of nivaldipine API. The domestic API supply is highly concentrated, with leading enterprises accounting for nearly 70% of the domestic market share. With the gradual increase in the standardized treatment rate of hypertensive patients at the primary level, the clinical dosage of nivaldipine has maintained an annual growth rate of about 6% in recent years.

The original research enterprise of nivaldipine is Fujifilm Wako Pure Chemical Industries, Ltd. of Japan, with the original brand name "Nivadil". The core compound patent expired in 2003 in major markets such as Japan and Europe. The main dosage form approved for the original drug is tablet, including two specifications of 2mg and 4mg. The original tablets have been included in the Japanese Orange Book and the FDA Reference Listed Drug Catalog, and are used as reference preparations for the development of nivaldipine preparations. At present, there is no imported original preparation on the market in China, and all approved domestic nivaldipine preparations are tablets. 3 domestic enterprises have obtained A-status registration of nivaldipine API on the CDE API registration platform, which can meet the domestic preparation production demand. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of nivaldipine impurity reference standards, covering all types of reference materials such as process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully support the testing needs at all stages of API R&D, production and quality research.