Aspartame

As a new type of non-peptide angiotensin Ⅱ receptor antagonist, azilsartan blocks the AT₁ receptor with high selectivity, inhibits vasoconstriction and aldosterone release, and achieves a stable and long-term antihypertensive effect. Compared with traditional antihypertensive drugs, it has a lower incidence of adverse reactions such as dry cough and angioedema. Its indications include essential hypertension and hypertension complicated with type 2 diabetic nephropathy. It can also be used for adult patients who cannot tolerate ACEI drugs. Long-term administration can significantly reduce the risk of cardiovascular and cerebrovascular events, and it is currently one of the core options in individualized hypertension treatment regimens.

The prevalence of hypertension in China reaches 27.5%, with a patient base of more than 300 million, which drives the continuous expansion of the sartan antihypertensive drug market. In 2023, the overall market size of domestic sartan API was approximately 4.8 billion yuan, with a compound annual growth rate maintained at around 6.2%. Among them, azilsartan, as the latest generation of sartan varieties, although its current market share is less than 5%, its growth rate is significantly higher than that of similar products. In terms of the competitive landscape, there are no legally marketed generic drugs in China at present, and the original research product occupies the entire market share. It is expected that the substitution space for generic drugs will be rapidly released after the patent expires, and the demand for related APIs will enter a period of explosive growth.

The original research enterprise of azilsartan is Japan's Tanabe Mitsubishi Pharma, with the trade name "Micardis". Its Chinese compound patent expired in 2020. At present, the original research dosage form approved in China is tablets, with three specifications of 20mg, 40mg and 80mg, which have been included in the *National Essential Medicines List* and the reference preparation directory issued by NMPA. As of the time of retrieval, there are 8 azilsartan registration numbers in total on the CDE API registration platform, among which 3 are in A status and can be jointly reviewed with associated preparations. Several domestic enterprises have obtained marketing approval for generic preparations through consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for azilsartan API, which are developed in strict accordance with the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. The data of structure confirmation and purity calibration are complete, which can fully meet the needs of the whole process of API research and development, quality research and registration declaration. Most impurity reference standards are in sufficient stock. Orders placed before 16:00 can be shipped on the same day, which effectively shortens customers' R&D cycle and reduces supply chain uncertainty.