Bepridil

Cardiovascular disease is the leading cause of death worldwide. Among them, angina pectoris, as a common clinical manifestation of coronary heart disease, has a large patient group that has long faced the problem of limited medication options. Bepridil is a long-acting calcium channel blocker, which can simultaneously block the slow calcium ion channel and potassium ion channel, and has multiple effects of inhibiting myocardial contraction, dilating blood vessels, and slowing down heart rate. It is a rare broad-spectrum anti-myocardial ischemia drug that can be used for long-term treatment of chronic stable angina pectoris, especially suitable for patients who are poorly controlled by β-receptor blockers or nitrate drugs alone. It can significantly reduce the frequency of angina pectoris attacks and improve the exercise tolerance of patients.

At present, the global market size of bepridil is approximately USD 210 million, with a compound annual growth rate of around 3.2% in the past five years. The growth momentum mainly comes from the improvement of the diagnosis and treatment rate of cardiovascular diseases in low- and middle-income countries. In terms of the competitive landscape, the original research product still accounts for about 60% of the market share in Europe and the United States, and generic drug manufacturers are mainly concentrated in India and China. Among them, Indian enterprises occupy more than 70% of the generic drug market in Southeast Asia by virtue of cost advantages; there is no centralized procurement record of this variety in China, and the market supply is dominated by imported preparations and a small number of generic drugs.

The original research enterprise of bepridil is Bristol-Myers Squibb in the United States, with the original research trade name Vascor, and the core compound patent expired in 1999. The main dosage form approved by the original research is tablet, with three specifications including 100mg, 200mg and 300mg. The original research tablet has been included in the FDA Reference Listed Drug Catalog, but not included in the Chinese Catalog of Chemical Drugs. Up to now, no valid API registration number of bepridil has been found on the CDE API registration platform, and there is no approval information for the marketing of preparations of this variety in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of bepridil impurity reference standards, supporting the entire process of impurity research needs from R&D to declaration. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and core indicators such as impurity purity and traceability meet the declaration standards of domestic and foreign drug regulatory authorities, helping cooperative enterprises reduce R&D risks and shorten project cycles.