Fluvastatin

Cardiovascular disease is one of the disease types with the highest fatality rate globally. As a core inducing factor, dyslipidemia has long plagued clinical treatment. Fluvastatin, as the first fully chemically synthesized hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, competitively inhibits the activity of the rate-limiting enzyme for endogenous cholesterol synthesis and blocks the mevalonate metabolic pathway in hepatocytes, so as to effectively reduce the levels of total cholesterol, low-density lipoprotein cholesterol and triglyceride, and increase high-density lipoprotein cholesterol at the same time. It is a first-line lipid-regulating drug for adult patients with primary hypercholesterolemia and mixed dyslipidemia, and can also be used for patients with coronary heart disease to reduce the risk of myocardial infarction and stroke.

In recent years, the global market size of lipid-regulating drugs has remained steadily above 30 billion US dollars, among which statins account for nearly 60%. With the clinical advantages of unique metabolic pathway and fewer interactions with other commonly used cardiovascular drugs, the penetration rate of fluvastatin in elderly patients with multiple underlying diseases continues to rise, and its global market compound annual growth rate has maintained at around 3.2% in the past three years. At present, the domestic fluvastatin preparation market has formed a pattern of coexistence of original research drugs and generic drugs. Generic drugs from 7 enterprises have passed the consistency evaluation. In 2022, the winning bid price in provincial centralized procurement saw a maximum decrease of 87% compared with the original research drug, further promoting the accessibility of clinical medication.

The original research enterprise of fluvastatin is Novartis Pharmaceuticals, and the original research trade name is Lescol. The core compound patent expired in the United States and the European Union in 2011, and the core patent in China expired in 2010. The main dosage forms approved for the original research product include 20mg, 40mg and 80mg sustained-release tablets and common capsules, which have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA reference preparation catalogue. Up to now, there have been 12 domestic registration numbers of fluvastatin API, among which 8 are in Status A (applicable for marketing preparation declaration), and another 13 domestic approved fluvastatin preparation approval numbers. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for fluvastatin API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for enterprises' API R&D, quality research and consistency evaluation work.