Pravastatin

Cardiovascular disease is one of the chronic diseases with the highest mortality rate in the world. Dyslipidemia is its core inducing factor, and the clinical demand for safe and effective lipid-regulating drugs continues to grow. Pravastatin belongs to 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, and it is the first water-soluble statin synthesized by microorganisms. It competitively inhibits the rate-limiting enzyme in cholesterol synthesis to reduce cholesterol production in the liver, and at the same time upregulates the expression of low-density lipoprotein receptors to accelerate the clearance of low-density lipoprotein in plasma. Clinically, it is mainly used for the treatment of hypercholesterolemia and mixed hyperlipidemia, and can also be used for the secondary prevention of coronary heart disease and stroke. The applicable population covers middle-aged and elderly patients with dyslipidemia and people at high risk of cardiovascular disease. Due to its lower liver and kidney toxicity, it is more suitable for dyslipidemia patients with mild abnormal liver and kidney function.

The global market size of pravastatin was approximately USD 620 million in 2023. With the improvement of the primary cardiovascular disease prevention and control system, it is expected to maintain a compound annual growth rate of 2.1% from 2024 to 2029. In terms of the domestic market, pravastatin has been included in the national centralized procurement catalog. The winning bid price has dropped by more than 80% compared with the price of the original research drug, and the overall market size is stable at around RMB 1.2 billion. In the competitive landscape, domestic generic drugs account for more than 90% of the market share. The production of APIs is concentrated in Zhejiang, Guangdong and other regions. The API production capacity of leading enterprises has covered more than 80% of the domestic preparation production demand, and more than 30% of the API production capacity is used for export to supply the European and American markets.

The original research enterprise of pravastatin is Daiichi Sankyo Co., Ltd., and the original research trade name is Mevalotin. The expiration date of its core compound patent in the United States is 2005, and the expiration date of the Chinese compound patent is 2004. The main dosage forms approved for the original research product are tablets, with specifications including 10mg, 20mg and 40mg. This original research product has been included in the Catalogue of Marketed Drugs in China as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are more than 20 API registration numbers of pravastatin sodium on the API registration platform of China CDE, most of which are in A status and can be directly used for associated review; more than 30 domestic enterprises have been approved to produce preparation varieties such as pravastatin sodium tablets and capsules. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full range of impurity reference standards for pravastatin. Most of the products are available in stock. For stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of API enterprises in different links such as impurity research, quality control, and registration and declaration.