Warfarin

Thromboembolic diseases are one of the chronic disease complications with the highest fatality rate worldwide, and oral anticoagulants are the core medications for long-term clinical prevention and control of thrombosis. Warfarin is a coumarin vitamin K antagonist. It inhibits the activation of vitamin K-dependent coagulation factors Ⅱ, Ⅶ, Ⅸ and Ⅹ, and blocks the key link of the coagulation cascade. It is one of the oral anticoagulants with the longest clinical use time and the most sufficient evidence-based evidence so far. It is not only suitable for stroke prevention in patients with atrial fibrillation and after heart valve replacement, but also can be used for the treatment and recurrence prevention and control of deep vein thrombosis and pulmonary embolism. It is the basic medication for anticoagulant therapy in primary medical institutions.

As a classic anticoagulant, the global market size of warfarin has long been stable at around RMB 3 billion, and its annual sales in the Chinese market are approximately RMB 600 million. In recent years, impacted by new oral anticoagulants, its growth rate has slowed down to less than 2%. However, due to its low price and controllable anticoagulant effect, it still maintains an irreplaceable position in the primary market and special indication fields such as valvular heart disease. The domestic preparation market is dominated by generic drugs. At present, warfarin sodium tablets from more than 20 enterprises have passed the consistency evaluation. In the local centralized procurement in 2022, the winning price dropped to about RMB 0.15 per tablet, which further improved the accessibility in primary medical institutions.

The original research enterprise of warfarin is Bristol-Myers Squibb, and the original research brand name is Coumadin. Its core compound patent expired globally in 1960. The main dosage form of the original research product launched globally is warfarin sodium tablets, with specifications covering four common doses of 1mg, 2mg, 3mg and 5mg. The original research tablets have been included in the FDA Reference Listed Drug Directory and the *Catalogue of Reference Preparations for Chemical Drugs* of China. Up to now, there have been 11 registration entries of warfarin sodium API on the API registration platform of China NMPA Center for Drug Evaluation (CDE), among which 8 are in status A and can be supplied for domestic preparation production; there are more than 30 domestic approval numbers for warfarin sodium tablet preparations, and the original research preparation has also been approved for marketing in China. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of warfarin impurity reference standards, fully covering synthetic process impurities, degradation impurities and corresponding isotope internal standards. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products have sufficient spot inventory. Spot orders paid before 16:00 can be shipped on the same day, which can provide reliable reference material support for the whole process of R&D links of pharmaceutical enterprises such as API quality research, consistency evaluation and stability study.