Lovastatin

Cardiovascular diseases are the type of diseases with the highest mortality rate globally. As one of the core inducing factors, dyslipidemia creates a long-term clinical demand for safe and effective lipid-regulating drugs. Lovastatin is a statin HMG-CoA reductase inhibitor. It competitively inhibits the key rate-limiting enzyme in the cholesterol synthesis process to reduce the production of endogenous cholesterol, and at the same time upregulates the expression of low-density lipoprotein receptors to accelerate the clearance of serum low-density lipoprotein. It is mainly used clinically to treat hypercholesterolemia and mixed hyperlipidemia, and can also be used for the prevention and treatment of coronary heart disease and stroke. Its applicable population covers patients with primary hypercholesterolemia and high-risk groups of cardiovascular diseases with concurrent dyslipidemia. It is one of the basic lipid-regulating drugs recommended by blood lipid management guidelines.

Lovastatin is the first statin drug launched in the world. At present, the global market size of statin drugs exceeds 10 billion US dollars, among which the market size of lovastatin-related preparations is about 320 million US dollars. In recent years, affected by the popularization of generic drugs and the rising demand for primary-level medication, the compound annual growth rate has remained at around 2.1%. For the domestic market, the oral regular-release dosage forms of lovastatin have been included in the national centralized procurement catalog. The average winning bid price has dropped by more than 70% compared with that before the centralized procurement. The overall market supply is dominated by generic drugs. Domestic API manufacturers are concentrated in Zhejiang, Guangdong and other regions, and the API production capacity can meet more than 60% of the global market demand.

The original developer of lovastatin is Merck Sharp & Dohme, and the original brand name is Mevacor. Its core US compound patent expired in 2001, and its Chinese compound patent has also expired. The main dosage form of the original product is tablet, with specifications including 10mg, 20mg and 40mg. The original tablets have been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. As of now, there are more than 30 lovastatin API registration entries on the API registration platform of China's Center for Drug Evaluation (CDE), most of which are in Status A and can be legally supplied for domestic preparation production. A number of domestic enterprises have obtained marketing approval for lovastatin tablets and capsules. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of lovastatin impurity reference standards, fully covering various impurity reference substances such as intermediates in the synthesis process and degradation products. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of different scenarios such as API research and development, quality research, and quality control in the production process.