Simvastatin

Cardiovascular disease is one of the chronic diseases with the highest mortality rate worldwide. As dyslipidemia is its core risk factor, the clinical demand for lipid-regulating drugs has always remained high. Simvastatin is a lipid-regulating drug belonging to the category of hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It competitively inhibits the key rate-limiting enzyme in the cholesterol synthesis process to reduce cholesterol production in the liver, and simultaneously upregulates the expression of low-density lipoprotein receptors to accelerate the clearance of plasma low-density lipoprotein. Clinically, it is mainly used for the treatment of hypercholesterolemia and mixed hyperlipidemia, and can also be used for the secondary prevention of atherosclerotic cardiovascular diseases such as coronary heart disease and stroke. The applicable population covers middle-aged and elderly patients with concomitant dyslipidemia and high-risk groups with a family history of cardiovascular diseases.

At present, the global market size of lipid-regulating drugs exceeds 30 billion US dollars, among which statins account for nearly 40%. As a representative variety of the second-generation statins, simvastatin has a stable usage volume in primary medical institutions and long-term chronic disease management scenarios. The annual sales of simvastatin preparations in the Chinese market exceed 1.5 billion yuan. Driven by the centralized procurement policy, the market penetration rate of generic drugs has exceeded 90%, and the demand for API continues to grow along with the volume expansion of generic drugs. Domestic manufacturers are mainly concentrated in Zhejiang, Guangdong and other provinces, and the production capacity of leading enterprises accounts for more than 60%.

The original research enterprise of simvastatin is Merck Sharp & Dohme, and the original brand name is Zocor. The core compound patent of simvastatin expired in the United States in December 2005, and the compound patent in China expired in 2004. The main dosage forms approved for the original drug include tablets and capsules, with specifications covering 5mg, 10mg, 20mg and 40mg. The original tablets have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. Up to now, there are more than 30 simvastatin API registration numbers on the API registration platform of China CDE, most of which are in status A (approved for use in marketed preparations). There are more than 200 domestically approved simvastatin preparation varieties, covering multiple dosage forms such as tablets, capsules and dry suspensions. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for simvastatin API, with most products in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the quality research and impurity reference needs of API manufacturers and preparation R&D institutions.