Xarelto (Rivaroxaban) API Manufacturers & Suppliers
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Rivaroxaban | CAS No: 366789-02-8 | GMP-certified suppliers
A medication that supports prevention and treatment of venous and arterial thromboembolic conditions, including postoperative VTE, atrial‑fibrillation–related stroke, DVT/PE, and pediatric VTE needs.
Therapeutic categories
Primary indications
- Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery
- Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
- To reduce risk of recurrent DVT and/or PE
Product Snapshot
- Rivaroxaban is an oral small-molecule anticoagulant supplied mainly as tablets, capsules, and granules for suspension
- It is used for VTE prevention and treatment, stroke prevention in nonvalvular atrial fibrillation, reduction of recurrent thromboembolic events, and cardiovascular risk reduction in select adult and pediatric populations
- It is approved in major regulated markets including the US, EU, and Canada
Clinical Overview
Rivaroxaban produces anticoagulation by directly and competitively inhibiting free and clot‑associated factor Xa, preventing the conversion of prothrombin to thrombin and reducing fibrin formation. Its action disrupts the amplification phase of coagulation without requiring antithrombin III. The inhibition is functionally irreversible over the dosing interval. Although it prolongs aPTT and HepTest values in a dose‑dependent manner, these assays are not suitable for monitoring, and routine anti‑Xa testing is not recommended.
Absorption is dose dependent, with the 15 mg and 20 mg strengths requiring administration with food to optimize bioavailability, while the 10 mg dose can be taken without regard to meals. Rivaroxaban is a substrate of CYP3A, P‑glycoprotein, and BCRP, with mixed hepatic and renal elimination. Clinically relevant drug interactions may occur with strong inhibitors or inducers of these pathways. The absence of a routinely available reversal agent underscores the need for careful patient selection and bleeding risk assessment.
For API procurement, sourcing should prioritize verified manufacturers with robust control of impurities and particle‑size distribution, as these parameters influence oral absorption and regulatory compliance.
Identification & chemistry
| Generic name | Rivaroxaban |
|---|---|
| Molecule type | Small molecule |
| CAS | 366789-02-8 |
| UNII | 9NDF7JZ4M3 |
| DrugBank ID | DB06228 |
Pharmacology
| Summary | Rivaroxaban is an oral anticoagulant that selectively and competitively inhibits free and clot‑associated factor Xa, a central enzyme required for thrombin generation. By blocking factor Xa–mediated conversion of prothrombin to thrombin, it suppresses amplification of the coagulation cascade and limits fibrin clot formation. Its activity is direct and does not require antithrombin III. |
|---|---|
| Mechanism of action | Rivaroxaban competitively inhibits free and clot bound factor Xa. Factor Xa is needed to activate prothrombin (factor II) to thrombin (factor IIa). Thrombin is a serine protease that is required to activate fibrinogen to fibrin, which is the loose meshwork that completes the clotting process. Since one molecule of factor Xa can generate more than 1000 molecules of thrombin, selective inhibitors of factor Xa are profoundly useful in terminating the amplification of thrombin generation. The action of rivaroxaban is irreversible. |
| Pharmacodynamics | Rivaroxaban is an anticoagulant which binds directly to factor Xa. Thereafter, it effectively blocks the amplification of the coagulation cascade, preventing the formation of thrombus. Rivaroxaban is a unqiue anticoagulant for two reasons. First of all, it is does not involve antithrombin III (ATIII) to exert its anticoagulant effects. Secondly, it is an oral agent whereas the widely used unfractionated heparin and low molecular weight heparins are for parenteral use only. Although the activated partial thromboplastin time (aPTT) and HepTest (a test developed to assay low molecular weight heparins) are prolonged in a dose-dependant manner, neither test is recommended for the assessment of the pharmacodynamic effects of rivaroxaban. Anti-Xa activity and inhibition of anti-Xa activity monitoring is also not recommended despite being influenced by rivaroxaban. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Coagulation factor X | Humans | antagonist |
ADME / PK
| Absorption | Following oral administration, rivaroxaban is rapidly absorbed and reaches peak plasma concentration in 2-4 hours. Bioavailability of the 10 mg dose is >80%. However, the 15-20 mg dose have a lower bioavailability if taken in the fasted state and consequently should be taken with food. |
|---|---|
| Half-life | The terminal half life is 5-9 hours in adults and 11-13 hours in the elderly. |
| Protein binding | Plasma protein binding is about 92% to 95% |
| Metabolism | Approximately two-thirds of the dose is metabolized. It is metabolized by CYP3A4, CYP3A5, CYP2J2 and CYP-independant mechanisms |
| Route of elimination | Approximately two-thirds of rivaroxaban is excreted into urine (via active tubular secretion in which approximately 36% as unchanged drug and 30% as inactive metabolism). The remaining third of the administered dose is excreted via feces in which 7% is in the form of unchanged drug and 21% as inactive metabolites. |
| Volume of distribution | The steady state Vd is 50 L |
| Clearance | Systemic clearance is approximately 10 L/h, so rivaroxaban is considered a drug with low clearance. Renal clearance is ~3-4 L/h. |
Formulation & handling
- Oral small‑molecule anticoagulant with low aqueous solubility, requiring solid‑dose designs that enhance dissolution and maintain consistent exposure.
- Absorption is food‑sensitive at higher strengths, so formulation teams may account for fed‑state variability when developing oral products.
- Stable as a solid API; handling focuses on controlling particle size and flow to ensure uniformity in tablets, capsules, and reconstitutable granules.
Regulatory status
| Lifecycle | The API is in a late‑stage lifecycle, with most patents expired and the final U.S. protection ending in early 2025. With products already marketed in Canada, the EU, and the U.S., the market landscape reflects a mature phase with potential for expanded generic entry. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Rivaroxaban is supplied globally by a single originator developer, with branded and generic products present across the US, EU, and Canada. Multiple patents in Canada and the United States have already expired, and the remaining U.S. patent expires in early 2025, indicating that generic competition is already established in some markets and likely to expand further. This creates a diversified manufacturing landscape with multiple non‑originator suppliers entering post‑expiry. |
|---|
Safety
| Toxicity | Excessive bleeding. Overdosages should be treated using activated charcoal and supportive measures such as mechanical compression and hemodynamic support. If bleeding is not controlled, the following procoagulants can be administered: activated prothrombin complex concentrate, prothrombin complex concentrate and recombinant factor VIIa. There is also a higher chance of post procedural hemorrhage compared to enoxaparin (1.55% vs. 1.39% respectively). |
|---|
- High anticoagulant activity is associated with excessive bleeding risk, with reported post‑procedural hemorrhage rates slightly higher than enoxaparin
- Overexposure may require specialized coagulation management due to potential for uncontrolled bleeding
- Handling and development work should account for its potent inhibition of clot formation and associated hemodynamic impact in overdose scenarios
Rivaroxaban is a type of Antithrombotics
Antithrombotics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in preventing and treating thrombotic disorders, which are characterized by the formation of blood clots within blood vessels. These medications are essential in reducing the risk of thrombosis, such as deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke, which can lead to severe health complications.
Antithrombotics exert their therapeutic effects through various mechanisms. One commonly used class of antithrombotics is anticoagulants, which inhibit the clotting process by interfering with the formation of blood clots. These drugs include heparin, warfarin, and direct oral anticoagulants (DOACs). They are administered to patients with conditions like atrial fibrillation, venous thromboembolism, or mechanical heart valves to prevent clot formation.
Another class of antithrombotics is antiplatelet agents, which prevent platelet aggregation, an essential step in blood clot formation. Aspirin, clopidogrel, and ticagrelor are well-known antiplatelet drugs used to prevent thrombosis in patients with coronary artery disease, ischemic stroke, or peripheral artery disease.
Antithrombotics are typically prescribed based on the individual patient's risk factors, medical history, and the specific thrombotic condition being treated. Dosage and administration instructions may vary depending on the drug's pharmacokinetic profile and desired therapeutic outcomes.
As with any medication, antithrombotics may have potential side effects, such as increased bleeding risk. Therefore, healthcare professionals carefully assess the patient's overall health status, including any underlying conditions, before prescribing these medications.
In conclusion, antithrombotics are a crucial subcategory of pharmaceutical APIs that play a vital role in preventing and treating thrombotic disorders. By inhibiting clot formation through various mechanisms, these medications significantly contribute to reducing the risk of serious complications associated with blood clots.
Rivaroxaban (Antithrombotics), classified under Anticoagulants
Anticoagulants are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to prevent and treat blood clotting disorders. These medications play a crucial role in various medical conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF). Anticoagulants work by inhibiting the formation of blood clots or by preventing existing clots from getting larger.
There are different types of anticoagulants available, including direct thrombin inhibitors, vitamin K antagonists, and factor Xa inhibitors. Direct thrombin inhibitors, such as dabigatran, directly target the enzyme thrombin to hinder clot formation. Vitamin K antagonists, like warfarin, interfere with the production of clotting factors that rely on vitamin K. Factor Xa inhibitors, such as rivaroxaban and apixaban, inhibit the activity of factor Xa, a crucial component in the clotting cascade.
Anticoagulants are commonly prescribed to patients at risk of developing blood clots or those with existing clotting disorders. They are often used during surgeries, such as hip or knee replacements, to minimize the risk of post-operative clot formation. Patients with AF, a condition characterized by irregular heart rhythm, may also be prescribed anticoagulants to prevent stroke caused by blood clots.
While anticoagulants offer significant benefits in preventing and treating clot-related conditions, they also carry potential risks, including bleeding complications. Patients taking anticoagulants require careful monitoring to ensure the right dosage is administered, as excessive anticoagulation can lead to hemorrhage. Regular blood tests and close medical supervision are essential to manage the delicate balance between preventing clots and avoiding excessive bleeding.
In conclusion, anticoagulants are a crucial category of pharmaceutical APIs used to prevent and treat blood clotting disorders. They function by inhibiting clot formation or preventing existing clots from enlarging. While highly beneficial, their use requires careful monitoring to minimize the risk of bleeding complications.
Rivaroxaban API manufacturers & distributors
Compare qualified Rivaroxaban API suppliers worldwide. We currently have 50 companies offering Rivaroxaban API, with manufacturing taking place in 14 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Amino Chemicals | Producer | Malta | Malta | CoA, GMP | 20 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, JDMF, KDMF, MSDS, USDMF | 243 products |
| Bakul Pharma Private Limi... | Producer | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 52 products |
| Bayer | Producer | Germany | Unknown | CoA, GMP, USDMF | 42 products |
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Farmak | Producer | Czech Republic | Czech Republic | CoA, GMP | 19 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Gedeon Richter | Producer | Hungary | Hungary | CoA, GMP | 48 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| HEC Pharm | Producer | Germany | Unknown | CoA, USDMF | 31 products |
| Intas Pharma | Producer | United Kingdom | Unknown | CoA, USDMF | 30 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 52 products |
| Kinsy | Producer | Spain | Spain | CoA, GMP | 9 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Medichem | Producer | Spain | Malta | CoA, GMP | 39 products |
| Menovo | Producer | China | China | CoA, GMP | 27 products |
| Micro Labs | Producer | India | India | CoA, USDMF | 38 products |
| Moehs | Producer | Spain | Spain | CoA, GMP | 50 products |
| Morepen Laboratories Ltd. | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC | 22 products |
| MSN Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 119 products |
| Piramal Pharma Solutions | Producer | India | India | CoA, USDMF, WC | 44 products |
| Polpharma | Producer | Poland | Poland | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF | 64 products |
| Qilu Antibiotics | Producer | China | China | CoA, WC | 33 products |
| Quimica Sintetica | Producer | Spain | Spain | CoA, GMP | 51 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 55 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| Srini Pharma | Producer | India | India | CoA, GMP | 12 products |
| Suanfarma | Distributor | Spain | Spain | CEP, CoA, FDA, GDP, GMP, ISO9001, USDMF | 13 products |
| Symed Labs | Producer | India | India | CoA, GMP, USDMF, WC | 28 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unichem Labs. | Producer | India | India | CoA, USDMF | 62 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CoA, GMP, MSDS, USDMF, WC | 37 products |
| Vonage Pharma (Former Plu... | Producer | Turkey | Turkey | CoA, GMP, MSDS, USDMF, WC | 28 products |
| Weijie Pharmaceuticals | Producer | China | China | CoA, USDMF | 15 products |
| ZCL Chemicals | Producer | India | India | CoA, Other, FDA, ISO9001, USDMF | 30 products |
| Zhejiang Changming | Producer | China | China | CoA, GMP | 19 products |
| Zhejiang Charioteer | Producer | China | China | CoA, USDMF | 9 products |
| Zhejiang Supor | Producer | China | China | CoA, USDMF, WC | 13 products |
When sending a request, specify which Rivaroxaban API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Rivaroxaban API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
