Rosuvastatin

Cardiovascular disease is the disease category with the highest mortality rate globally. As a core inducing factor, dyslipidemia has long had an urgent demand for clinical management. Rosuvastatin is a statin lipid-regulating drug. It competitively inhibits HMG-CoA reductase to reduce cholesterol synthesis in the liver, and at the same time upregulates the expression of low-density lipoprotein receptors to accelerate lipid clearance. It is one of the statins with the highest lipid-lowering intensity at present. In addition to patients with primary hypercholesterolemia and mixed dyslipidemia, this drug is also suitable for the primary prevention of populations at high risk of cardiovascular events, and can significantly reduce the risk of myocardial infarction, stroke and atherosclerosis-related complications.

In recent years, the global market size of rosuvastatin has remained stable at more than 3 billion US dollars, among which the sales volume of China's public hospital terminal market in 2023 was about 1.8 billion yuan. As the core patent has expired for many years, generic drugs dominate the market. There are more than 40 domestic preparation enterprises that have passed the consistency evaluation, and the market share of the top five enterprises accounts for more than 70%. After the implementation of volume-based procurement, the price of preparations has dropped by more than 90%, and the cost control of upstream API has become one of the core competitiveness of enterprises. The annual domestic demand for API has exceeded 500 tons, and the compound growth rate in the past three years has remained at about 8%.

The original developer of rosuvastatin is AstraZeneca, with the original brand name "Crestor". Its core compound patent in the United States expired in 2016, and its compound patent in China also expired in 2016. The main dosage forms of the original drug include tablets, with specifications covering 5mg, 10mg, 20mg and 40mg, and it 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 30 registration numbers of rosuvastatin calcium API on the API registration platform of China CDE, among which more than 20 are in A status. The domestically approved rosuvastatin preparation varieties cover multiple dosage forms such as tablets and capsules. (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 rosuvastatin API. 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 meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various scenarios including API R&D, quality research and routine production quality control.