Fluvastatin

Against the background of the continuously rising incidence of cardiovascular diseases, statins are the core medications for the management of dyslipidemia. As a fully synthetic HMG-CoA reductase inhibitor, fluvastatin is a representative variety among them that combines both safety and efficacy. It competitively inhibits the key rate-limiting enzyme in the cholesterol synthesis process to reduce endogenous cholesterol production, and at the same time upregulates the activity of low-density lipoprotein receptors to accelerate the clearance of bad cholesterol in plasma. It is clinically mainly used for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia, and can also be used for the secondary prevention of people with coronary heart disease complicated by dyslipidemia, to reduce the risk of cardiovascular events such as myocardial infarction and stroke, and is especially suitable for elderly people with dyslipidemia complicated by mild abnormalities of liver and kidney function.

In 2023, the overall domestic market size of statin API exceeded 4.5 billion yuan. As a core variety of moderate-intensity statins, fluvastatin accounts for approximately 8.7% of the market, and its compound annual growth rate has remained at 6.2% in the past three years. In terms of the competitive landscape, its core patent has expired for many years. At present, there are fewer than 10 domestic API enterprises producing in compliance, so the supply concentration is relatively high. In the seventh batch of national centralized drug procurement, the number of winning enterprises for fluvastatin preparations reached 8. After the implementation of the centralized procurement, the demand for API increased by 41% compared with that before the centralized procurement, and the market gap is still at a high level. There is no publicly verifiable data on the separate global market size of fluvastatin API.

In response to the impurity research needs of downstream API manufacturers and preparation R&D institutions, CATO can provide a full set of impurity reference standards for fluvastatin API. All products simultaneously meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and more than 90% of the categories support spot delivery, which can help customers greatly shorten the cycle of impurity qualitative and quantitative research and reduce R&D compliance risks.