尼卡地平

In response to the emergency treatment needs of hypertensive emergencies and abnormal hypertension during surgery, calcium channel blocker antihypertensive drugs have always been the first-line clinical choice, among which nicardipine is a representative variety with both high vascular selectivity and controllable antihypertensive effect. It specifically inhibits calcium ion influx in vascular smooth muscle, dilates peripheral blood vessels, coronary arteries and cerebral blood vessels. It has a fast onset of antihypertensive effect and short duration, and the dose can be accurately adjusted through intravenous infusion to avoid the risk of sudden blood pressure drop. In addition to patients with hypertensive emergencies, it is also suitable for elderly people with hypertension complicated by insufficient cerebral blood supply and coronary heart disease, and has high clinical recognition in the scenario of perioperative blood pressure reduction.

The global market size of nicardipine has reached 1.27 billion US dollars, with a compound annual growth rate of 6.2% in the past three years. The growth momentum mainly comes from the expansion of perioperative antihypertensive demand and the improvement of the primary hypertensive emergency treatment system. In the domestic market, generic drugs account for more than 85%. In the 5 batches of centralized procurement that have been carried out, the winning bid price of nicardipine injection has decreased by 72% on average, driving the clinical penetration rate to increase from 23% in 2020 to 41% in 2023. The demand for APIs continues to release with the implementation of centralized procurement. At present, 11 domestic enterprises have obtained preparation production approvals, and the corresponding API supply gap has gradually narrowed in recent years.

The original research enterprise of nicardipine is Astellas Pharma, and the original research trade name is "Perdipine". Its US compound patent expired in 2018, and its core Chinese patent expired in 2016. The main dosage form of the original research is nicardipine hydrochloride injection, with the specification of 10ml:10mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation listed by FDA. Up to now, there are 18 pieces of nicardipine API registration information on the API registration platform of China CDE, among which 9 are in the status of "A" (can be used in marketed preparations), and 17 nicardipine hydrochloride injection preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for nicardipine API, covering a total of 27 kinds of synthetic process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the relevant regulatory requirements of Chinese Pharmacopoeia and FDA, and can be directly used for impurity research, quality standard establishment and release testing, effectively shortening the R&D and compliance declaration cycle of enterprises.