Ramipril

Cardiovascular diseases have long ranked first among the causes of death globally. The excessive activation of the renin-angiotensin-aldosterone system (RAAS) is one of the core pathological mechanisms for the progression of hypertension and heart failure. Ramipril is a third-generation angiotensin-converting enzyme inhibitor (ACEI). It competitively inhibits the activity of ACE to reduce the production of angiotensin II, and meanwhile inhibits the degradation of bradykinin. It has multiple effects including dilating blood vessels, lowering blood pressure, improving ventricular remodeling, and reducing urinary protein. Its clinical indications cover essential hypertension, mild to moderate heart failure occurring after acute myocardial infarction, and non-diabetic nephropathy. It is especially suitable for hypertensive populations with high cardiovascular risk factors and diabetic nephropathy, and is a first-line antihypertensive and cardiovascular event prevention drug recommended by guidelines of multiple countries.

The global market size of ramipril preparations is stably around 1.2 billion US dollars. In recent years, affected by the popularization of generic drugs, its growth rate has remained in the range of 1.8%-2.3%. The sales volume of ramipril at terminals of public medical institutions in China is approximately 320 million yuan, with a year-on-year growth of 4.1% in 2023. Among them, the original research product occupies nearly 60% of the market share, and there are 7 domestic generic drug manufacturers that have passed the consistency evaluation. In the provincial centralized drug procurement in 2024, the average price reduction of this variety reached 58%, and the penetration rate in the primary market is expected to further increase in the future.

The original research enterprise of ramipril is Sanofi, and the original trade name is "Tritace". The expiration dates of its core compound patent in the United States and Europe are 2005 and 2004 respectively, and the compound patent in China expired in 2003. The main dosage form of the original research product is tablet, including three specifications of 2.5mg, 5mg and 10mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the reference preparation catalogue of the FDA. Up to now, there are 11 ramipril registration records on the API registration platform of China National Medical Products Administration Center for Drug Evaluation (CDE), among which 8 have been activated with A status, and 12 generic varieties of ramipril tablets have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of ramipril impurity reference standards, covering the whole chain of starting materials, intermediates and degradation impurities. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the testing needs of pharmaceutical enterprises in various scenarios such as API R&D, quality research, and generic drug consistency evaluation.