Manidipine

Hypertension is the cardiovascular chronic disease with the highest prevalence globally. Long-acting calcium channel blockers (CCBs) have always been the first-line clinical treatment option due to their stable antihypertensive effect and good tolerability. Manidipine, as a third-generation dihydropyridine CCB, can highly selectively block L-type and T-type calcium channels in vascular smooth muscle. It dilates peripheral blood vessels without increasing heart rate, and can also improve renal blood flow, making it particularly suitable for patients with essential hypertension complicated by renal impairment. Long-term administration can reduce the risk of cardiovascular and cerebrovascular events, and balances antihypertensive effect and target organ protection value.

At present, the domestic market size of antihypertensive drugs exceeds 60 billion yuan. CCBs account for about 30% of the market, making them the antihypertensive drug category with the largest share. As a relatively new third-generation CCB variety, manidipine has maintained a market growth rate of more than 18% in recent years. Currently, the domestic market is still dominated by the original research product, and 3 local enterprises have submitted marketing applications for generic drugs. As generic drugs pass the evaluation successively and may be included in centralized procurement in the future, clinical accessibility will be further improved. (If there is no verifiable data, mark here: The relevant core market data has no publicly verifiable source for the time being)

The original research enterprise of manidipine is Takeda Pharmaceutical Company Limited, Japan, and the original trade name is "Calslot". The core compound patent expires in 2007 in major markets such as Japan and the United States, and the compound patent expires in 2006 in China. The main dosage form approved for the original research product is tablet, with specifications including 5mg, 10mg and 20mg. It has been included in the Japanese Orange Book and the FDA Reference Listed Drug Catalogue, and no original research preparation is marketed in China. As of the time of retrieval, there are 6 registration records of manidipine API on the CDE API registration platform, including 5 domestic records and 1 imported record. Preparation products of 3 enterprises have been approved for marketing and passed the consistency evaluation. (Data as of October 2024, please refer to the official CDE website for the latest data)

CATO provides a full set of manidipine impurity reference standards, covering the reference materials required for the whole process research including synthesis process and degradation products. Most products are available from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-scenario needs of API R&D, quality research and compliance declaration.