Amlodipine

Hypertension is the chronic cardiovascular disease with the highest prevalence rate worldwide, and the total number of patients has exceeded 1.2 billion. Calcium channel blockers are one of the core categories of drugs for clinical antihypertensive treatment. Amlodipine is a long-acting dihydropyridine calcium channel blocker. It can selectively block the calcium channels on the cell membrane of vascular smooth muscle, reduce the influx of extracellular calcium, relax vascular smooth muscle, then dilate peripheral arteries and reduce vascular resistance, so as to exert a stable and long-lasting antihypertensive effect. In addition to essential hypertension, this drug can also be used for the symptomatic treatment of chronic stable angina pectoris and variant angina pectoris. The applicable population covers hypertensive patients of different age groups, and it is especially suitable for elderly hypertensive patients complicated with coronary heart disease. With a long half-life of 35-50 hours, it only needs to be taken once a day to maintain a stable plasma concentration for 24 hours, leading to higher medication compliance.

At present, amlodipine is one of the antihypertensive drugs with the highest prescription volume in the world, and the domestic market scale is stably above 8 billion yuan. Among them, the annual demand of the API market exceeds 1,000 tons, and the average annual growth rate in the past three years has maintained at around 6%. In terms of competitive landscape, domestic generic drug enterprises occupy the main market share. As the core patents have long expired, there are more than 30 existing API manufacturers, and the total production capacity of enterprises in East China and North China accounts for more than 70%. After the implementation of centralized procurement, API cost control has become the core competitiveness of preparation enterprises, and the market concentration of leading API enterprises is gradually increasing.

The original research enterprise of amlodipine is Pfizer, and the original trade name is "Norvasc". Its core compound patent expired worldwide in 2007. The main dosage form approved by the original research is tablet, with conventional specifications including 2.5mg, 5mg and 10mg, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA Reference Preparation Catalogue. On the domestic side, more than 50 amlodipine APIs have completed registration in CDE at present (more than 40 registration numbers are in status A). The approved and marketed preparation varieties cover multiple dosage forms such as conventional tablets, dispersible tablets and capsules, and the number of enterprises that have passed the consistency evaluation exceeds 60. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of amlodipine quality research and compliance declaration, CATO can provide a full set of impurity reference standards for this API. 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 requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises for impurity qualitative and quantitative research, quality standard establishment and registration declaration.