Urapidil

Hypertension is one of the cardiovascular chronic diseases with the highest prevalence in the world. The demand for rapid blood pressure reduction in severe hypertension and perioperative hypertensive emergencies has put forward higher requirements for the target organ protective effect of antihypertensive drugs. Urapidil is an α1 receptor blocker and a central serotonin 1A receptor agonist. It dilates peripheral blood vessels and reduces sympathetic nerve activity through a dual mechanism of action. It does not cause reflex tachycardia while lowering blood pressure, and has little effect on heart rate. It is widely used in clinical practice for the control of hypertensive crisis and perioperative hypertension, and can also be used for the long-term treatment of severe hypertension, especially for elderly hypertensive patients with coronary heart disease and renal insufficiency.

At present, the market size of domestic urapidil preparations has exceeded 2 billion yuan, and the compound annual growth rate in the past three years has remained at around 12%. In clinical practice, injections are the core dosage form used, accounting for more than 90% of the overall market share. In terms of the competitive landscape, the original research product still accounts for about 35% of the market share. Nearly 30 domestic enterprises have obtained the approval documents for generic preparations, among which 8 enterprises have their injection products passed the consistency evaluation. They have been included in multiple batches of the national centralized procurement catalog successively, and the winning bid price has dropped by more than 70%, further promoting the improvement of the accessibility of clinical medication.

The original research enterprise of urapidil is Takeda GmbH (Germany), with the original trade name "Ebrantil" (domestic trade name: 优匹敌). Its core compound patent expired worldwide in 2001, and the preparation patent in China expired in 2008. The main dosage forms approved by the original research are injections and sustained-release capsules, among which the specifications of injections are 25mg/5ml and 50mg/10ml, and the specifications of sustained-release capsules are 30mg and 60mg. Both the original injection and sustained-release capsules have been included in the China Listed Drug Catalog as reference preparations, and are also included in the FDA Reference Preparation Catalog. As of now, there are more than 20 urapidil API registration numbers on the API registration platform of China CDE, among which 12 are in A status, which can be used for the declaration of associated domestic preparations. More than 20 urapidil generic preparations have been approved for marketing in China. (Data as of October 2025, please refer to the official website of CDE for the latest information)

In the process of drug R&D and quality control, impurity research is the core link to ensure the safety of APIs and preparations. CATO provides a full set of urapidil impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable research material support for pharmaceutical enterprises in API quality research, consistency evaluation and post-marketing quality control.