Benidipine

Hypertension is a chronic cardiovascular disease affecting more than 1.2 billion patients worldwide, and long-acting calcium channel blockers are a core component of first-line clinical antihypertensive regimens. Benidipine belongs to the second-generation dihydropyridine calcium channel blockers, which can simultaneously block L-type, N-type and T-type calcium channels. It can not only steadily reduce peripheral vascular resistance to achieve 24-hour long-acting antihypertensive effect, but also reduce the activation of the sympathetic nerve, and lower the risk of adverse reactions such as renal damage and lower limb edema. In addition to essential hypertension, this drug is also indicated for the treatment of angina pectoris, especially suitable for populations with combined renal function impairment and elderly hypertensive patients, with outstanding clinical compliance and safety performance.

At present, the global market size of benidipine has exceeded 1.2 billion US dollars, with a compound annual growth rate of 4.8% in the past five years. The Asia-Pacific region is the core consumer market, accounting for 68% of the total global market size. The growth rate of the Chinese market is higher than the global average, with a compound annual growth rate of 7.2%. The currently marketed preparations are mainly generic drugs, which have been included in the seventh batch of national centralized drug procurement. The winning bid price has decreased by an average of 67% compared with that before the centralized procurement. With the increase of the penetration rate of primary medical medication, the market demand still has room for continuous release.

The original research enterprise of benidipine is Kyowa Hakko Kirin Co., Ltd. of Japan, and the original research trade name is "Coniel". Its core compound patent expired in Japan in 2006, and the core compound patent in China expired in 2007. The dosage forms approved for the original research drug include tablets, with three specifications of 2mg, 4mg and 8mg. It has been included in the Chinese *Catalogue of Reference Preparations of Chemical Drugs* and also included in the FDA Reference Preparations Catalogue. In terms of domestic API registration, as of now, the benidipine APIs of more than 10 enterprises have passed the examination and registration of CDE, and the generic preparations of several domestic enterprises have been approved for marketing and passed the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for benidipine API, which can cover the whole process of testing requirements from R&D to application for approval. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, providing stable and reliable support for enterprises' R&D and quality control links.