Indobufen

Cardiovascular and cerebrovascular diseases have become the category of chronic diseases with the highest mortality rate globally, and antiplatelet therapy is the core regimen for the secondary prevention of such diseases. Indobufen is a highly selective reversible inhibitor of cyclooxygenase-1 (COX-1). It blocks the platelet aggregation process by inhibiting the production of thromboxane A2, without excessive impact on prostacyclin synthesis, so the risk of gastrointestinal adverse reactions is significantly lower than that of traditional aspirin. This drug is suitable for the prevention and treatment of ischemic cardiovascular and cerebrovascular lesions caused by arteriosclerosis and venous thrombosis, and can also be used to prevent thromboembolism during hemodialysis, especially for long-term use in high thrombotic risk populations intolerant to aspirin.

In recent years, the market size of antiplatelet drugs in China has been stable at more than 15 billion yuan. As a differentiated antiplatelet treatment option, indobufen has achieved a compound annual growth rate of more than 22% in the past three years, far higher than the average growth rate of similar products. At present, generic drugs account for 78% of the domestic market. After the implementation of centralized procurement, the price of winning bids has dropped by more than 60%, the accessibility at the primary level has been greatly improved, the clinical dosage has continued to rise, and the demand of the upstream and downstream industrial chain has maintained a rapid expansion trend.

The original research enterprise of indobufen is Farmfalia Carlo Erba, an Italian company, with the original trade name Ibustrin®. Its core compound patent expired globally in 2004. The main dosage form of the original product is tablet, with specifications of 100mg and 200mg, which has been included in the *Catalogue of Chemical Reference Preparations* of China. Up to now, there are 12 domestic registration numbers for indobufen active pharmaceutical ingredients, 9 of which are in status A. In addition, indobufen tablets from 6 enterprises have been approved for marketing, all of which have passed the quality and efficacy consistency evaluation of generic drugs. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for indobufen API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable and reliable reference standard support for API R&D, quality research and registration declaration.

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