CAS 79902-63-9

General Information

Simvastatin belongs to the class of lipid-lowering compounds known as ‘statins’. Generally, statins work by reducing the level of low-density lipoprotein (LDL) cholesterol in the blood by inhibiting the liver enzyme responsible for its production.

High blood cholesterol levels are associated with cardiovascular diseases such as dyslipidemia (abnormal blood lipid level) and atherosclerosis (narrowing of the artery walls by accumulation of fatty deposits, or ‘plaques’). Accordingly, statins are mainly indicated for the prevention and treatment of such diseases.

Simvastatin is typically prescribed as an adjunct to a cholesterol-reduced diet.

After patent expiry in 2006, simvastatin has become available in several generic formulations.

Simvastatin’a synthetic derivative of a fermentation product of Aspergillus terreus’is presently manufactured by large-scale fermentation, a well-established industrial method using microorganisms to convert raw materials to valuable commercial product through chemical transformations. Through careful strain selection and continuous strain improvement, the process has been streamlined for maximum productivity and yield.

About the API

Systematic name (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydro-1-naphthalenyl 2,2-dimethylbutanoate
Trade name(s) Zocor, Synvinolin
Technology Fermentation
Molecular Formula C25H38O5
Molecular Weight 418.566 g/mol
Physical properties White/off-white crystalline powder
Therapeutic category Lipid lowering
Available formulations Oral Solid Oral Solid Long-Acting
Regulations CEP Flag CEP EU DMF Flag EU DMF Japan DMF Flag Japan DMF Korea DMF Flag Korea DMF US DMF Flag US DMF