Amlodipine

As the chronic cardiovascular disease with the highest prevalence in the world, hypertension has a patient population of more than 1.2 billion, among which calcium channel blockers are the core category of first-line clinical antihypertensive drugs. Amlodipine is a long-acting dihydropyridine calcium antagonist. By selectively blocking L-type calcium channels on vascular smooth muscle and myocardial cells, it reduces the influx of extracellular calcium ions, relaxes vascular smooth muscle and lowers peripheral vascular resistance, thus exerting a stable and long-lasting antihypertensive effect. A single administration of amlodipine can achieve a 24-hour coverage of antihypertensive effect, and rarely causes reflex tachycardia. In addition to essential hypertension, this drug can also be used for the symptomatic treatment of chronic stable angina pectoris and variant angina pectoris. Its applicable population includes elderly patients with hypertension, patients complicated with diabetes or peripheral vascular disease, and it is one of the antihypertensive drugs with the highest clinical prescription volume at present.

The global market size of amlodipine is stable at around USD 9 billion, and the annual sales at the terminals of domestic public medical institutions exceed RMB 6 billion, with an annual growth rate maintained at 3% to 5%. The patent of the original research product "Norvasc" developed by Pfizer has long expired. There are more than 70 domestic generic drug enterprises, among which more than 30 have had their preparation products pass the consistency evaluation. After amlodipine was included in the national centralized procurement catalogue, the price reduction of winning bids exceeded 90%. The demand for API continues to rise along with the volume expansion of generic drugs. The annual production capacity of domestic amlodipine API has exceeded 200 tons, and local enterprises occupy a dominant position in the global supply system.

In response to the R&D and quality control needs of generic drug enterprises, CATO provides a full set of impurity reference standards for amlodipine API. All products are in stock and meet the quality standards under multiple regulatory systems such as Chinese Pharmacopoeia and FDA. They can directly support the consistency evaluation declaration and routine production quality testing of amlodipine preparations, helping enterprises shorten the R&D cycle and reduce compliance risks.