Cilnidipine

As a highly prevalent chronic cardiovascular disease, long-term poor blood pressure control of hypertension can easily induce severe complications such as stroke and myocardial infarction, and the clinical demand for drugs with both stable antihypertensive effect and target organ protective effect continues to rise. Cilnidipine is a third-generation dihydropyridine calcium channel blocker, which can block both L-type and N-type calcium channels. While dilating peripheral vessels to lower blood pressure, it can inhibit sympathetic activation, avoid the adverse reaction of reflex tachycardia commonly seen with conventional calcium antagonists, and also improve renal blood flow. It is especially suitable for adult hypertensive patients with combined renal function impairment and sympathetic excitation, and can also be used for long-term maintenance treatment of senile hypertension.

In 2023, the domestic market size of calcium channel blocker antihypertensive drugs exceeded 28 billion yuan, among which the annual compound growth rate of long-acting dual-channel blocking varieties reached 7.2%, higher than the average growth rate of common calcium antagonists. At present, the cilnidipine market is dominated by generic drugs. More than 15 domestic enterprises have obtained preparation approval documents. After centralized procurement, the price of a single tablet has dropped to less than 0.5 yuan, and the clinical accessibility has been greatly improved. The supply of upstream API has basically realized localization, and only a small amount of API for high-end preparations relies on imports.

The original research enterprise of cilnidipine is Toyama Chemical Co., Ltd. under the Japanese FUJIFILM Corporation, and the original trade name is "Cilnidipine Tablets (Sunesis®)". Its core compound patent in Japan expired in 2012, and the expiration date of the compound patent in China is 2013. The original dosage form is tablet, with specifications including 5mg and 10mg, which has been included in the Catalogue of Marketed Drugs in China as the reference preparation. At present, 12 domestic enterprises have obtained the A status of cilnidipine API through CDE registration, the total number of domestic preparation approval documents exceeds 30, and the original research preparation has also been approved to enter the Chinese market. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for cilnidipine API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and fully meet the full-process R&D and production needs of API manufacturers, including quality research, stability study, and release testing.