Nitrendipine

Cardiovascular diseases are chronic diseases with high incidence worldwide. Calcium channel blockers are one of the core categories of clinical antihypertensive treatment, and nitrendipine belongs to the second-generation dihydropyridine calcium channel blockers. Its mechanism of action is to selectively block the calcium channels of vascular smooth muscle and myocardium, preferentially dilate peripheral blood vessels and coronary arteries, reduce peripheral vascular resistance without significantly inhibiting myocardial contraction. It is mainly used clinically for the treatment of essential hypertension, especially suitable for elderly hypertensive patients with coronary atherosclerosis. It can also assist in relieving angina pectoris symptoms caused by coronary heart disease, and long-term medication can reduce the risk of cardiovascular events.

At present, the global market size of antihypertensive drugs has exceeded 60 billion US dollars, of which calcium channel blockers account for about 18%. As a basic antihypertensive drug, nitrendipine has a continuously increasing penetration rate in the primary medical market due to its affordable price and stable antihypertensive effect. The compound annual growth rate of the global API market demand in the past three years has remained at about 4.2%. In terms of the domestic market, this product has been included in the National Essential Medicines List and the centralized procurement lists of several provinces. After centralized procurement, the price of preparations has dropped by more than 70%, driving the demand for upstream APIs to increase by 38% year-on-year. At present, domestic API manufacturers are mainly concentrated in Jiangsu and Shandong provinces, and the overall competitive landscape is relatively fragmented.

The original research enterprise of nitrendipine is Bayer Pharma, and the original research trade name is "Bayotensin". Its core compound patent expired worldwide in 1997. The main dosage form approved for the original research is tablet, with specifications of 10mg and 20mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. In terms of the domestic market, more than 20 enterprises have obtained Class A status for their nitrendipine APIs through CDE registration, which can be legally used for preparation declaration. The total number of approved marketing authorization numbers for domestic nitrendipine tablets has exceeded 300, with sufficient market supply. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the demand for impurity reference standards in the R&D and quality control links of nitrendipine APIs and preparations, CATO can provide a full set of impurity reference standards for this variety, and most products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the relevant needs of impurity qualitative and quantitative research and release testing.