Telmisartan

Cardiovascular diseases are the category of chronic diseases with the highest mortality rate globally. Among them, hypertension, as the most common underlying chronic disease, is prone to induce serious complications such as myocardial infarction, stroke and kidney injury if not well controlled for a long time. Telmisartan belongs to angiotensin Ⅱ receptor antagonist (ARB) class of antihypertensive drugs. It blocks the AT1 receptor of angiotensin Ⅱ with high selectivity, inhibits vasoconstriction and aldosterone release, and has target organ protective effect while stably lowering blood pressure. It is widely used clinically for the long-term treatment of essential hypertension, especially suitable for hypertensive patients complicated with myocardial hypertrophy, diabetic nephropathy and atherosclerosis, and is also the first-choice alternative for patients intolerant to ACEI drugs.

At present, the global market size of ARB class antihypertensive drugs exceeds 13 billion US dollars. Telmisartan, with its advantages of long-acting antihypertensive effect and low side effects, accounts for about 18% of the ARB market. The annual sales of telmisartan at the terminals of Chinese public medical institutions have remained above 2.5 billion yuan for years, with an average annual growth rate of around 6%. The domestic preparation market presents a pattern of coexistence of original research drugs and generic drugs. More than 40 enterprises have obtained the approval documents for telmisartan preparations, among which 19 enterprises have their products passed the consistency evaluation. Telmisartan has been included in the national centralized procurement catalogue, and the price of the winning products has dropped by more than 90% compared with the original research drug, greatly improving the clinical accessibility.

The original research enterprise of telmisartan is Boehringer Ingelheim, with the trade name Micardis. Its core compound patent in China expired in 2018. The main dosage form approved for the original research drug is tablet, with conventional specifications including 20mg, 40mg and 80mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by NMPA, and is also a reference preparation recognized by FDA. Up to now, there are more than 60 registration entries of telmisartan API on the CDE API registration platform, among which more than 30 are in status A, which can be legally supplied for domestic preparation production. The domestically approved and marketed telmisartan preparations cover multiple dosage forms such as tablets, capsules and dispersible tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of telmisartan impurity reference standards, which fully cover the impurities generated during the synthesis process, degradation impurities and reference substances required for stability studies. Most products are regularly kept in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference substance support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.