Gemfibrozil

Dyslipidemia is one of the core controllable risk factors for cardiovascular diseases. For a long time, there has been a lack of medication options with both safety and cost-effectiveness for clinical intervention in hypertriglyceridemia, and the clinical application of gemfibrozil has filled the treatment gap in this细分领域. As a fibric acid derivative lipid-regulating drug, its mechanism of action is to inhibit peripheral lipolysis, reduce the hepatic uptake of free fatty acids, and thereby decrease the hepatic synthesis of triglycerides. Meanwhile, it can slightly increase the level of high-density lipoprotein cholesterol, and reduce the concentrations of low-density lipoprotein and total cholesterol. Clinically, it is mainly used for patients with type Ⅳ and type Ⅴ hyperlipoproteinemia who have poor efficacy after diet control and exercise adjustment, and can also be used for patients with type Ⅱb hyperlipoproteinemia who have high risk of coronary heart disease and do not respond to other lipid-lowering therapies.

The market size of domestic lipid-regulating drugs has exceeded 35 billion yuan. Among them, the annual compound growth rate of fibrate drugs for hypertriglyceridemia remains at around 4.2%. As a classic fibrate drug, gemfibrozil maintains a stable market share of around 11% in the primary market. At present, the domestic market is dominated by generic drugs. More than 20 enterprises have obtained manufacturing approvals for preparations, and domestic enterprises have sufficient supply of active pharmaceutical ingredients (APIs), realizing complete import substitution. Gemfibrozil has not been included in the national centralized volume-based procurement program, so the price fluctuation at all levels of terminals is small.

The original developer of gemfibrozil is Pfizer, with the original brand name "Lopid". Its core compound patent in the US market expired in 1999. The main dosage form of the original marketed product is tablet with a specification of 600mg, which has been included in the FDA Reference Listed Drug Catalog, and also included in the China Listed Drug Catalog as a reference preparation. According to the domestic API registration platform, more than 15 enterprises have completed the A-status registration of gemfibrozil APIs. Domestic preparations have been approved for marketing for many years, covering two common dosage forms: tablets and capsules. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of gemfibrozil impurity reference standards. Most products are available in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable material basis support for API and preparation enterprises in their work of quality research, stability study, registration and declaration, etc.