Amiodarone

Arrhythmia is one of the cardiovascular diseases with high incidence worldwide. Among them, malignant arrhythmias such as ventricular tachycardia and atrial fibrillation have extremely high risk of death, and there has been a long-term lack of broad-spectrum and safe control drugs in clinical practice. As a classic class III antiarrhythmic drug, amiodarone can prolong the duration of myocardial action potential by blocking potassium channels, and also has mild blocking effects on sodium channels, calcium channels and non-competitive α/β adrenergic receptors. It has definite curative effects on both supraventricular and ventricular arrhythmias, and is a core drug for emergency rescue and long-term rhythm control, which is widely applicable to patients with arrhythmia complicated with organic heart disease.

At present, the global amiodarone market size is stable at around USD 1.2 billion, and the annual sales in the Chinese market exceed RMB 1.8 billion, with a compound growth rate of 4.2% in the past three years. As it has been clinically applied for more than 40 years, generic amiodarone occupies a dominant position in the market. There are more than 30 domestic preparation manufacturers, among which the oral dosage form has been included in the national centralized volume-based procurement, and the price of the selected products has dropped by more than 80%. The demand for upstream API has gradually concentrated on large-scale and low-cost supply.

The original developer of amiodarone is Sanofi, with the original brand name "Cordarone". The core compound patent expired worldwide in 1998. The currently marketed original dosage forms include 200mg oral tablets and 150mg/3mL injections, both of which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and are also listed in the FDA Reference Preparation Catalogue. 12 publicly announced amiodarone API registration numbers (status A) can be found on the domestic API registration platform, and another 6 registration information are under review. The total number of domestic approved oral and injectable amiodarone preparation varieties exceeds 50. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for amiodarone API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference standard support for the whole process of API R&D, quality research and declaration.