Digoxin

Cardiovascular disease is one of the chronic diseases with high incidence worldwide, among which the clinical medication demand for heart failure and arrhythmia remains stable for a long time. Digoxin is a cardiac glycoside drug. By inhibiting the Na⁺-K⁺-ATPase on the myocardial cell membrane, it increases the calcium ion concentration in myocardial cells, thereby enhancing myocardial contractility, slowing down the heart rate, and inhibiting the cardiac conduction system. It is a classic drug for the clinical treatment of acute and chronic heart failure, atrial fibrillation, and paroxysmal supraventricular tachycardia, applicable to patients of all ages who need to improve cardiac function. It has a clinical application history of more than half a century since its launch, and is one of the basic drugs in the cardiovascular field.

The global digoxin market size is approximately USD 230 million, and the Chinese market size is approximately RMB 320 million. In recent years, with the expansion of the heart failure patient population, the overall market maintains a steady annual growth rate of 3%-5%. In terms of the competitive landscape, the domestic preparation market is dominated by generic drugs, with the original research product accounting for less than 10%. Domestic enterprises have achieved independent production capacity supply on the API supply side, and part of the production capacity is exported to Southeast Asia, Europe, America and other markets. In 2022, digoxin oral solution was included in the 7th batch of centralized drug procurement organized by the state, with an average price reduction of more than 60% for the winning bids, which further promoted the improvement of drug accessibility and also drove the steady growth of upstream API demand.

The original research enterprise of digoxin is Sanofi, and the original research brand name is "Lanoxin" (Keli). Its core compound patent expired worldwide in 1982. The main dosage forms approved for the original research product include tablets (0.25mg), oral solution (0.05mg/ml) and injection (0.5mg/2ml), which have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA reference preparation catalogue. Up to now, there are 12 digoxin API registration entries on China CDE API Registration Platform, among which 8 have passed the joint evaluation and approval with preparations. More than 20 domestic enterprises have obtained marketing approval for digoxin tablets, oral solutions and injections. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of digoxin impurity reference standards, covering all categories such as synthesis 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 comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the use requirements of various stages such as API R&D, quality research, and registration declaration.