Prazosin

As a chronic cardiovascular disease affecting more than 1.2 billion people worldwide, hypertension is treated with α-receptor blockers as one of the preferred options for patients with concomitant prostatic hyperplasia. Prazosin is a selective α1-adrenergic receptor blocker. It dilates peripheral arteries and veins and reduces peripheral vascular resistance by blocking α1 receptors on vascular smooth muscle, while it does not reflexively increase the heart rate. In addition to being used alone or in combination with other antihypertensive drugs to treat various types of hypertension, it can also improve the dysuria symptoms of patients with benign prostatic hyperplasia, and is especially suitable for middle-aged and elderly patients with hypertension complicated by prostatic hyperplasia.

As a mature antihypertensive product that has been on the market for many years, the global market size of prazosin is stable at around USD 120 million, with an annual compound growth rate of approximately 2.3%. The growth mainly comes from the increasing demand for affordable antihypertensive drugs from primary medical institutions. In the domestic market, the proportion of original research products is less than 15%, and generic drugs dominate the market. At present, nearly 30 enterprises have obtained the approval documents for prazosin preparations. The supply of active pharmaceutical ingredients is mainly from local enterprises, and the overall price is at a relatively low level. It is one of the winning products in the third batch of national centralized drug procurement, and the winning price has decreased by 68% on average compared with that before the centralized procurement.

The original research enterprise of prazosin is Pfizer, and the original trade name is Minipress. Its core compound patent expired worldwide in 1987. The main dosage form of the original marketed product is tablet, with specifications including 1mg, 2mg and 5mg. It has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (25th Batch)*. In terms of the domestic market, 12 enterprises have completed the registration of prazosin APIs in CDE and obtained A-status registration numbers, and another 27 enterprises have obtained the marketing approval for prazosin tablets, among which 11 have passed the consistency evaluation. (Data as of October 2024, please refer to the official website of CDE for the latest information.)

CATO provides a full set of impurity reference standards for prazosin API, which can fully meet the needs of the whole process of R&D and quality control. Most of the products are in stock. In-stock products ordered before 16:00 can be shipped on the same day. Meanwhile, they meet the requirements of pharmacopoeias of multiple countries such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in generic drug declaration, consistency evaluation and daily production quality testing.