Felodipine

Hypertension is one of the chronic cardiovascular diseases with the highest prevalence worldwide. Calcium channel blockers are a core category of medications for clinical antihypertensive therapy, and felodipine is a representative variety of highly selective dihydropyridines among them. It competitively binds to L-type calcium channels on the membrane of vascular smooth muscle cells, reduces the influx of extracellular calcium, relaxes vascular smooth muscles and dilates peripheral arteries. While lowering blood pressure, it has an extremely weak inhibitory effect on the myocardium and can also improve coronary blood supply. Clinically, it is used for monotherapy or combination therapy of essential hypertension in patients of all age groups, and can also be used for symptom relief of stable angina pectoris. Long-term use can significantly reduce the risk of cardiovascular and cerebrovascular events, and it has good compliance.

At present, the global market size of felodipine exceeds 1.2 billion US dollars, with the Chinese market accounting for approximately 32%, and the compound annual growth rate has remained at 4.7% in the past three years. As a commonly used basic antihypertensive drug in clinical practice, felodipine has been included in the National Essential Medicine List and multiple rounds of national centralized procurement. The price reduction of winning bids exceeds 80%, which drives the continuous increase in clinical usage. In terms of the competitive landscape, the domestic preparation market has formed a situation where the original research drugs and generic drugs coexist. More than 30 enterprises have had their felodipine preparations pass the consistency evaluation. The demand for APIs is stable and the procurement volume continues to expand, and there is no clear supply gap for the time being.

The original research enterprise of felodipine is AstraZeneca, and the original brand name is "Plendil". The core compound patent of it expired around 2003 in major markets. The main dosage form approved for the original research drug is sustained-release tablets, with specifications including 2.5mg and 5mg, which have been included in the Chinese Chemical Medicine Reference Preparation Catalog and the FDA Reference Preparation Catalog. In terms of domestic API registration, nearly 20 enterprises including AstraZeneca have obtained A-status registration numbers for their felodipine APIs, and the registrations of several other enterprises are under review. A number of felodipine sustained-release tablets and conventional tablets have been approved for marketing in China, and most of them have passed the consistency evaluation. (Data as of November 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of felodipine, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. Meanwhile, the products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support pharmaceutical enterprises in impurity research, quality standard establishment and declaration work.