Arotinolol

In the clinical treatment of cardiovascular diseases such as hypertension and angina pectoris, drugs with dual blocking effects on both α and β receptors have always been an important option for optimizing treatment regimens, and arotinolol is a typical representative of this category of drugs. It reduces cardiac output and inhibits renin secretion by non-selectively blocking β receptors, and moderately blocks α receptors to dilate peripheral blood vessels. This not only avoids peripheral circulation disorders that may be caused by traditional β receptor blockers, but also synergistically lowers blood pressure, and improves the myocardial ischemia state of angina pectoris. In addition, it is also applicable for symptom control in patients with essential tremor, and the applicable population covers hypertension patients with comorbid dyslipidemia and impaired glucose tolerance, filling the treatment limitations of single receptor blockers.

At present, the global arotinolol market size has exceeded 1.2 billion yuan, and the annual compound growth rate of the Chinese market remains at around 7%, with the growth rate significantly higher than the global average. The domestic market is still dominated by the original research product at present. With the improvement of awareness among the applicable population and the improvement of the primary cardiovascular disease diagnosis and treatment network, there is still considerable room for the release of market demand. The layout of domestic generic drug enterprises is gradually advancing. At present, 3 enterprises have submitted applications for marketing authorization of generic drugs. In the future, with the launch of generic drugs, product accessibility will be further improved.

The original research enterprise of arotinolol is Sumitomo Pharma of Japan, and the original brand name is "ALMARL". Its compound patent in China expired in 2010. At present, the main dosage form of the original research product approved in China is tablet, with specifications of 5mg and 10mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration. In terms of domestic API registration, there are currently 6 arotinolol API registration numbers in total, among which 2 have obtained A status through joint review and evaluation with preparations, and 10 domestic enterprises have obtained marketing approval for arotinolol tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and production quality control needs of arotinolol, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered 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 needs of the whole process of R&D and production scenarios including impurity research, quality standard establishment, and release testing.