Atorvastatin

Cardiovascular disease is the leading cause of death globally, among which dyslipidemia, especially elevated low-density lipoprotein cholesterol, is the core risk factor inducing adverse cardiovascular events such as atherosclerosis and coronary heart disease. Atorvastatin belongs to the statin class of hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It competitively inhibits the key rate-limiting enzyme in the cholesterol synthesis process to reduce cholesterol synthesis in the liver, and simultaneously upregulates the expression of low-density lipoprotein receptors on the surface of hepatocytes to accelerate the clearance of bad cholesterol in plasma. Clinically, it is mainly used for the treatment of hypercholesterolemia and mixed dyslipidemia, and can also be used for the secondary prevention of high-risk populations of coronary heart disease and stroke. Its applicable population covers adult patients with dyslipidemia and children over 10 years old with familial hypercholesterolemia, and it is a basic drug in the field of lipid management.

As the most widely used lipid-regulating drug in the world, the global market peak of atorvastatin once exceeded 13 billion US dollars. After the patent expiration, generic drugs have been rapidly launched, and the current global generic drug market size remains around 3 billion US dollars. China is the main consumer market of atorvastatin preparations. In 2023, the terminal sales of domestic public medical institutions exceeded 7 billion yuan, among which the original research product accounted for about 42% of the market, and domestic generic drugs accounted for 58%. On the production side, nearly 60 domestic enterprises have obtained production approvals for atorvastatin preparations, and the localization rate of APIs exceeds 90%. Shandong, Zhejiang and other regions are the core production areas of domestic atorvastatin APIs. After the implementation of centralized procurement, the price of preparations has dropped by more than 80%, further driving the increase in clinical penetration.

The original research enterprise of atorvastatin is Pfizer, and the original research trade name is Lipitor. Its US compound patent expired in 2011, and the core compound patent in China expired in 2016. The mainstream dosage form of the original research product is tablet, with specifications including 10mg, 20mg, 40mg and 80mg. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, there are more than 70 atorvastatin API registration records on the API registration platform of China CDE, among which more than 40 registration numbers are in status A (can be used in marketed preparations). The domestically approved atorvastatin preparation dosage forms cover tablets, capsules, dry suspensions and other categories. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for atorvastatin APIs, which adapt to multi-scenario requirements such as full-process quality research, registration and declaration, and ex-factory inspection of atorvastatin APIs and preparations. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can quickly support the R&D and production quality control needs of enterprises.