Barnidipine

Hypertension, a chronic cardiovascular disease with high incidence worldwide, has a huge patient base. Calcium channel blockers (CCBs) are among the first-line clinical antihypertensive drugs. Barnidipine is a long-acting dihydropyridine CCB. It highly selectively blocks L-type calcium channels on the membrane of vascular smooth muscle cells, reduces extracellular calcium influx, and dilates peripheral blood vessels and coronary arteries. While lowering blood pressure steadily, it can also improve myocardial blood supply and reduce the damage to target organs caused by blood pressure fluctuations. Its indications include essential hypertension and renal hypertension, and it is especially suitable for hypertension patients with concomitant coronary heart disease or renal function impairment. Once-daily administration can maintain 24-hour long-acting antihypertensive effect, with higher medication compliance.

The global barnidipine market is mainly concentrated in East Asia, with Japan and China as the core consumer markets. The overall market size in 2023 was approximately USD 120 million, with a compound annual growth rate maintained at around 3.2%. Due to the early launch time of this drug, the current market is dominated by generic drugs, with the original research product accounting for less than 15%. In terms of the domestic market, more than 10 enterprises have been approved to produce barnidipine preparations. After the centralized procurement, the price of preparations has dropped by more than 70%, and the demand of downstream preparation enterprises for high-cost-effective APIs continues to rise. The supply pattern of upstream APIs is relatively scattered, and no enterprise has occupied an absolute monopoly position for now.

The original research enterprise of barnidipine is Astellas Pharma Inc. of Japan, with the original brand name "Hypoca". Its core compound patents in major markets such as Japan and China all expired in 2008. The main dosage form approved for the original product is barnidipine hydrochloride sustained-release capsules, with two specifications of 10mg and 15mg. This original dosage form has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China. Up to now, a total of 6 domestic enterprises have obtained Class A status for their barnidipine hydrochloride APIs through CDE registration, which can be legally supplied to domestic preparation manufacturers, and 11 domestic barnidipine sustained-release preparations have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of barnidipine impurity reference standards, fully covering impurities from the synthesis process, degradation impurities and reference substances required for stability studies. Most products are regularly in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API R&D, quality research and registration declaration.