Bezafibrate

Dyslipidemia is a core risk factor for cardiovascular diseases such as atherosclerosis and coronary heart disease. In the clinical treatment of hypertriglyceridemia and mixed hyperlipidemia, bezafibrate, as a clofibric acid derivative lipid-regulating drug, plays an important role. Its mechanism of action is to activate peroxisome proliferator-activated receptor α, regulate the activity of lipoprotein lipase, accelerate the degradation of triglycerides, while reducing the levels of low-density lipoprotein and cholesterol, and slightly increasing high-density lipoprotein. It is suitable for adult patients with hyperlipidemia whose blood lipids still fail to meet the standard after diet adjustment and exercise intervention, especially for people with dyslipidemia complicated with diabetes, and can simultaneously improve glucose metabolism indexes.

At present, the global lipid-regulating drug market continues to expand. With its definite efficacy on hypertriglyceridemia, bezafibrate accounts for about 17% of the market share of fibrate drugs, and its global market compound growth rate has remained at 4.2% in the past three years. In terms of the domestic market, with the advancement of hierarchical diagnosis and treatment and the increase of chronic disease management coverage, the annual growth rate of bezafibrate's in-hospital sales revenue is stable at around 6%, and its domestic production rate has exceeded 80% at present. After the implementation of centralized drug procurement, the price cut of winning bids reached 56%, which further improved the accessibility of medication at the primary level.

The original research enterprise of bezafibrate is Roche, and the original brand name is "Bezalip". Its core compound patent expired globally in 1999. The main domestically approved dosage forms include 200mg conventional tablets and 400mg sustained-release tablets. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* published by NMPA. Up to now, 21 domestic enterprises have obtained A-status registration numbers for bezafibrate APIs through the CDE registration platform, and 12 enterprises have obtained marketing approval for bezafibrate preparations, covering the two major dosage forms of conventional tablets and sustained-release tablets. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for bezafibrate API, which are developed and produced in strict accordance with the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most products are in stock regularly, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard needs of pharmaceutical enterprises in quality research, consistency evaluation and routine production processes.