Lercanidipine

Hypertension is the chronic cardiovascular disease with the largest number of patients worldwide, and calcium channel blockers are first-line clinical antihypertensive drugs. As a new generation of dihydropyridine calcium channel blocker, lercanidipine can highly selectively block L-type calcium channels on the membrane of vascular smooth muscle cells, reduce calcium ion influx, dilate peripheral blood vessels and thus lower blood pressure, and has minimal impact on cardiac conduction and myocardial contraction. With high liposolubility, long half-life and stable and long-lasting antihypertensive effect, it is applicable to patients with essential hypertension of all age groups, especially suitable for elderly people with comorbid atherosclerosis and abnormal hepatic and renal function. Its tolerability is superior to that of traditional dihydropyridine drugs, and its clinical application scope continues to expand.

At present, the global market size of lercanidipine is approximately USD 1.2 billion, with a compound annual growth rate maintained at around 4.2%, and the domestic market size is nearly RMB 1.8 billion. With the increase in the prevalence of hypertension and the growth of the elderly population, the growth rate is higher than the global average. In the domestic market, the original research product still accounts for about 35% of the market share, and nearly 20 pharmaceutical companies have been approved for generic preparations. After winning the bid in centralized procurement, the price has dropped by more than 70%, which promotes the rapid expansion of downstream preparation production capacity and directly drives the continuous rise in demand for upstream API. At present, there are fewer than 10 domestic enterprises registered for lercanidipine API, and the overall supply and demand pattern is tight.

The original research enterprise of lercanidipine is Recordati S.p.A. of Italy, with the original brand name "Zanidip". Its core compound patent in China expired in 2020. The main dosage form approved for the original research is tablet, with two specifications of 10mg and 20mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by FDA. Up to now, there are 8 DMFs of lercanidipine API in valid status registered with CDE, and lercanidipine tablets from the original research manufacturer and multiple generic pharmaceutical companies have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the demand for R&D and quality control related to lercanidipine, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and orders for in-stock products 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 various use needs of pharmaceutical enterprises in the links of R&D, production and quality testing.