Mevastatin

Hyperlipidemia is one of the core risk factors for the progression of cardiovascular diseases. The advent of statins has brought a landmark breakthrough in blood lipid regulation. Mevastatin, as the first statin active substance discovered worldwide, belongs to the HMG-CoA reductase inhibitor class of lipid-regulating drugs. It competitively inhibits the key rate-limiting enzyme in the cholesterol synthesis process to reduce endogenous cholesterol production, and simultaneously upregulates the expression of low-density lipoprotein receptors to accelerate the clearance of low-density lipoprotein in the blood. Clinically, it is mainly used for the treatment of primary hypercholesterolemia, and can also be used as an adjuvant medication for patients with combined hyperlipidemia. The applicable population covers patients with dyslipidemia who fail to respond to dietary control and have a high risk of cardiovascular diseases.

As a lead compound of statins, the market size of mevastatin is squeezed by subsequent derivative statin products. At present, the overall global market size is relatively small, mainly concentrated in the fields of API export and laboratory R&D application. In terms of the domestic market, mevastatin also serves as a key synthetic intermediate for subsequent statin products such as pravastatin, and its market demand is stable at the level of hundreds of tons per year. With the refined development of the characteristic API industry, the price differentiation trend between its industrial-grade and pharmaceutical-grade products is obvious.

The original research enterprise of mevastatin is Sankyo Co., Ltd. of Japan, and the original brand name is Mevacor. Its core compound patent expired worldwide in 1999. At present, the main marketed dosage form of the original product is oral tablet, with specifications including 10mg and 20mg. The original research tablet of this variety has been included in the FDA Reference Listed Drug Catalog, but has not been included in China's *Catalog of Reference Preparations for Chemical Drugs* for the time being. According to the domestic API registration platform, 3 domestic enterprises have obtained A-status registration numbers for mevastatin APIs so far, and the registration applications of another 2 enterprises are under review. A number of domestic enterprises have obtained approval for the marketing of generic mevastatin preparations. (Data as of April 2025, please refer to the official CDE website for the latest information)

In response to the R&D, production and quality control needs of mevastatin, CATO provides a full set of impurity reference standards for this API, which can accurately cover the whole process of quality control scenarios such as related substance inspection and content determination. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can efficiently support the generic drug consistency evaluation and routine production quality control work of pharmaceutical enterprises.