Indoramin

As an α₁-adrenoceptor antagonist antihypertensive drug, indoramin can competitively block α₁ receptors on vascular smooth muscle, dilate peripheral blood vessels and reduce peripheral resistance. Meanwhile, it does not cause reflex tachycardia, and its antihypertensive effect is stable and long-lasting. In clinical practice, in addition to being used for the treatment of various types of primary and secondary hypertension, it can also improve the urinary tract obstruction symptoms of patients with benign prostatic hyperplasia. It is especially suitable for elderly hypertensive patients with concomitant benign prostatic hyperplasia, and can reduce the risk of adverse reactions caused by combined medication.

Currently, there are more than 1.2 billion hypertensive patients worldwide, and elderly patients with concomitant benign prostatic hyperplasia account for more than 35%. With its unique dual-indication advantage, the global market size of indoramin maintains an annual growth rate of approximately 4.2%, and the market size in 2023 was approximately USD 180 million. The domestic market is still dominated by imported preparations at present, and the number of generic drug declaration enterprises is small. With the increase in medication demand of elderly patients with comorbidities, the market gap is gradually expanding, and there is no publicly verifiable data related to centralized procurement.

The original research enterprise of indoramin is Wyeth (US), with the trade name Baratol, and the core compound patent expired globally in 1999. The dosage form approved for the original research drug is tablet, with main specifications including 25mg and 50mg, and it has been included in the FDA Reference Listed Drug Catalog. There is no approval record of imported original research preparations in China. As of October 2024, the CDE API Registration Platform has not shown any indoramin API registration number in valid status, and there is also no indoramin preparation variety approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for indoramin API. Most products are routinely in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmaceutical regulatory regulations of multiple countries such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in each stage of generic drug research and development and quality research.