Diltiazem

Cardiovascular diseases are a group of chronic diseases with high incidence worldwide. As a core category of anti-anginal and anti-hypertensive drugs, non-dihydropyridine calcium channel blockers have long occupied an important share in the cardiovascular drug market. Diltiazem is one of the representative drugs in this category. By inhibiting the influx of calcium ions into vascular smooth muscle and myocardial cells, it effectively dilates coronary arteries and reduces peripheral vascular resistance, while slowing down the conduction velocity of the sinoatrial node and atrioventricular node. In clinical practice, it is not only used for the conventional treatment of angina pectoris and mild to moderate hypertension, but also for the intervention of supraventricular tachyarrhythmia. The applicable population covers hypertension patients with coronary artery spasm and tachycardia, and it is a commonly used drug with clear clinical pathways in the cardiovascular field.

According to public data, the overall domestic market size of diltiazem in 2023 was approximately 720 million yuan, and the compound annual growth rate in the recent 3 years has remained at around 4.6%. The growth drivers mainly come from the increase in the penetration rate of hypertension drugs at the primary level and the release of long-term management demand for angina pectoris. At present, the domestic preparation market is dominated by generic drugs. More than 20 enterprises have obtained the approval documents for diltiazem oral preparations, and more than 15 enterprises hold the approval documents for diltiazem injections. This variety has been included in multiple batches of national centralized procurement, and the price reduction of the selected products has exceeded 60%, which further drives the market demand for APIs.

The original research enterprise of diltiazem is Japan's Tanabe Mitsubishi Pharma. The original research trade names are "Herbesser" (oral tablet) and "Herbesser" (injection). Its core compound patent expired in 1999. The original oral immediate-release dosage form has a specification of 30mg, the sustained-release dosage form includes two specifications of 90mg and 120mg, and the injection has a specification of 10mg. All relevant dosage forms have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China. Up to now, nearly 30 domestic enterprises have completed the registration of diltiazem APIs in CDE and obtained Class A status. Meanwhile, the original research and many domestic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for diltiazem API. Most products are available from stock. For in-stock orders placed before 16:00, the delivery can be made on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of R&D, quality research and production quality control.