Ozagrel

Thrombotic diseases are the leading cause of death and disability worldwide, and anti-platelet aggregation is the core target for acute intervention and secondary prevention. Ozagrel is a selective thromboxane synthase inhibitor, which specifically blocks the production of thromboxane A2 while promoting the synthesis of prostacyclin to balance the pathways of thrombosis and vasodilation, thereby exerting the effects of inhibiting platelet aggregation, dilating cerebral vessels and improving cerebral microcirculation. It is clinically mainly used for acute thrombotic cerebral infarction and motor disorders accompanied by cerebral infarction, especially suitable for patients with ischemic stroke within 48 hours of onset, and can also be used to improve cerebral vasospasm and cerebral ischemia symptoms after subarachnoid hemorrhage surgery.

The domestic ozagrel market has maintained stable demand for a long time. In 2023, the sales volume of ozagrel preparations at the terminal of public medical institutions was close to 1.2 billion yuan, of which injections accounted for more than 98%, making it a commonly used antithrombotic drug in neurology. In terms of the competitive landscape, generic drugs have occupied a dominant position. At present, nearly 30 domestic enterprises have been approved to produce ozagrel injections. After the implementation of volume-based procurement, the price of preparations has dropped by more than 70%, and the cost control of upstream API has become the source of core competitiveness of preparation enterprises. The production of API is mainly concentrated in Chinese and Japanese manufacturers. 12 domestic enterprises have obtained the production approval for ozagrel API, with sufficient production capacity and supply.

The original research enterprise of ozagrel is Japan's Ono Pharmaceutical Co., Ltd., with the original brand name "Cataclot", and the core compound patent expired globally in 2009. The original dosage form is injection, with specifications including 20mg/vial lyophilized powder for injection and 80mg/vial injection. It has been included in the PMDA reference preparation catalog of Japan, and has not yet been included in the Catalog of Marketed Drugs in China. There are 13 domestic ozagrel API registration numbers, 8 of which are in A status and can be used for associated review. Multiple preparation varieties such as ozagrel sodium injection and ozagrel sodium for injection have been approved for marketing in China. (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 ozagrel API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference material support and technical service support for API production and consistency evaluation of preparations.