What Is Rivaroxaban API Used For? Applications in Anticoagulant Drug Development
What Is Rivaroxaban API Used For? Applications in Anticoagulant Drug Development
Last updated: 5 August 2026. For formulation, procurement and regulatory teams evaluating Rivaroxaban API. Product data follows our published specification; certification detail follows the certificates on file.
Rivaroxaban is a direct Factor Xa inhibitor used in oral anticoagulant formulations: stroke prevention in non-valvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism, and clot prophylaxis after hip or knee replacement. Bio-Synth manufactures it as a bulk API in Hyderabad to an assay of 98.0–102.0% w/w on the anhydrous substance, with total impurities limited to 0.3%.
How the molecule works
Factor Xa activates prothrombin into thrombin, thrombin converts fibrinogen into fibrin, and fibrin completes the clot. Rivaroxaban API interrupts that sequence at factor Xa, so blood takes longer to clot. The effect is predictable, routine coagulation monitoring is not required, and Cmax is reached in two to four hours. Few drug interactions, no dietary interactions. Against warfarin the molecule has shown equivalence, and in some cases superiority, in preventing stroke or systemic embolism.
What Rivaroxaban is used for
- Stroke prevention in adults with non-valvular atrial fibrillation
- Treatment of deep vein thrombosis in the legs and pulmonary embolism in the lungs
- Reducing recurrence in adults still at risk after at least six months of treatment
- Clot prophylaxis after hip or knee replacement surgery
- Clot prevention in adults hospitalised for acute illness, and after discharge, where mobility is reduced and bleeding risk is not high
- With low-dose aspirin, reducing cardiovascular risk in coronary artery disease and peripheral artery disease
Each indication carries a different formulation brief. Strength, dissolution target and particle size move with it, which is where Rivaroxaban API in formulations becomes a supplier conversation rather than a purchasing one.
Specification and physical properties
| Parameter | Value |
|---|---|
| CAS number | 366789-02-8 |
| Molecular formula | C19H18ClN3O5S |
| Molecular weight | 435.89 g/mol |
| Chemical name | (S)-5-chloro-N-{[2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl}thiophene-2-carboxamide |
| Category | Factor Xa inhibitor |
| Physical form | Powder, white or yellow |
| Assay | 98.0% – 102.0% w/w (anhydrous substance) |
| Total impurities | Maximum 0.3% |
| Any unspecified impurity | Maximum 0.1% |
| Solubility | Practically insoluble in water; freely soluble in dimethyl sulfoxide; practically insoluble in anhydrous ethanol and in heptanes |
| Storage | Air-tight container, below 30 °C |
| Packing | As per requirement |
Solubility is the line that catches teams out. A molecule practically insoluble in water needs particle size and dissolution work early, not after the first pilot batch. The Rivaroxaban API powder quality standards worth checking on receipt are set out separately.
The quality system behind the batch
Bio-Synth has made APIs and intermediates since 1943, at Plot No. 11/6/2029, Phase-2, SVCIE, Balanagar, Hyderabad, under manufacturer’s licence 118/HD/AP/96/B/R. The site holds ISO 9001:2015 certification from DNV under UKAS accreditation, certificate 156792-2014-AQ-IND-UKAS, scoped to “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”.
A WHO-GMP certificate is also held, issued by the Drugs Control Administration, Government of Telangana (L.Dis.No: 150458/TS/2024, dated 6 June 2024, valid until 5 June 2027). It is facility-level, covering the products named in the Joint Inspection Report.
Manufacturing follows ICH Q7 principles, the industry reference for GMP in active pharmaceutical ingredients, and the systems behind that sit on the quality and compliance page. None of it replaces your own audit. A certificate says a system was assessed on a date, not how your batch was made, which is why GMP certification for Rivaroxaban API makers is a starting point rather than a conclusion.
What to check before you commit
Read the batch Certificate of Analysis against the monograph you intend to register under, not against a marketing sheet. Bio-Synth holds Rivaroxaban CoAs at USP and BP/Ph.Eur grades.
Beyond the CoA, the usual pack is impurity data against ICH Q3A limits, residual solvents against ICH Q3C, and stability data to ICH Q1A conditions. Ask what has actually been generated for your grade, and by what method. Cost follows that answer, which is one reason Rivaroxaban API prices vary between Indian suppliers quoting what looks like the same product.
Why demand keeps climbing
Fortune Business Insights projects the global anticoagulant market at $43.5 billion by 2030, growing at 7.5% CAGR. The drivers are dull and durable: an ageing population, rising atrial fibrillation prevalence, a shift from injectable to oral anticoagulants, and health systems that favour generics. The competition is for reliable bulk supply, not for the molecule. To discuss volumes, grades or documentation, contact Bio-Synth with your specification.
FAQs
What is Rivaroxaban API used for?
It is the active ingredient in oral anticoagulant formulations: treatment of deep vein thrombosis and pulmonary embolism, stroke prevention in non-valvular atrial fibrillation, and clot prophylaxis after hip or knee replacement surgery.
How is Rivaroxaban different from warfarin?
It acts directly on factor Xa. The effect is predictable, routine coagulation monitoring is not required, there are no dietary interactions, and Cmax is reached in two to four hours.
Which grades does Bio-Synth supply?
Rivaroxaban Certificates of Analysis are held at USP and BP/Ph.Eur grades.
How should Rivaroxaban API be stored?
In an air-tight container below 30 °C. Packing is supplied as per requirement.
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