Rivaroxaban ships under two patent realities in one molecule: the 2.5 mg vascular-protection dose and the 10, 15 and 20 mg anticoagulation doses sit on separate exclusivity timelines, so sourcing strategy runs strength by strength.
Rivaroxaban is one molecule with two separate patent lives. The 2.5 mg tablet, dosed twice daily alongside aspirin for chronic coronary and peripheral artery disease, entered generic competition in the United States in March 2025. The 15 mg and 20 mg tablets, used for stroke prevention in atrial fibrillation and for acute venous thromboembolism treatment, and the 10 mg tablet, used for VTE prevention after hip or knee replacement and for reducing recurrent VTE risk after initial treatment, remain under originator exclusivity in that same market. M Care Exports sources rivaroxaban, referenced against Xarelto, across all four strengths from WHO-GMP certified Indian manufacturers, and quotes each line against the buyer's own destination registration.
Rivaroxaban exporter and bulk supplier from India.
Rivaroxaban ships as film-coated tablets, a stable oral solid with no cold-chain requirement, packed to standard pharmaceutical export specification with batch-level certificates of analysis. Because the four strengths carry different indications and, in some markets, different patent status, we confirm the buyer's target strength, brand or generic presentation, and destination registration before finalising a quote rather than after. Export documentation includes certificate of pharmaceutical product or free-sale certificate, GMP certificate for the manufacturing site, stability data and batch-specific COA, aligned to the importing country's dossier requirements. Labelling, pack text and any serialisation or track-and-trace marking are matched to the buyer's registered artwork, not to a generic template, since a mismatched pack is the most common cause of customs delay on a cardiovascular line.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Direct factor Xa inhibitor (oral anticoagulant, DOAC), sourced and documented for export.
Rivaroxaban's patent map is split by strength, not by molecule. In the United States, the 2.5 mg vascular-protection dose cleared generic entry in March 2025, while the 10 mg, 15 mg and 20 mg anticoagulation doses stay under originator exclusivity, so a tender desk sourcing the same INN can face two different registration realities on one purchase order. Clinically, rivaroxaban is an oral, direct factor Xa inhibitor. The 15 mg and 20 mg tablets are approved for stroke prevention in nonvalvular atrial fibrillation and for venous thromboembolism treatment; the 2.5 mg dose, combined with aspirin, is approved to reduce major cardiovascular events in chronic coronary artery disease and peripheral artery disease, including after lower-extremity revascularisation. Two boxed warnings apply: premature discontinuation risk and epidural or spinal hematoma with neuraxial procedures. Both belong in front of every buyer, not behind a data sheet.
Active ingredient
Rivaroxaban. Direct factor Xa inhibitor (oral anticoagulant, DOAC).
Forms and strengths
2.5 mg; 10 mg; 15 mg; 20 mg.
Indications
Rivaroxaban is an oral, direct factor Xa inhibitor referenced against the originator brand Xarelto. The 15 mg and 20 mg tablets are approved for stroke prevention in nonvalvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism; the 10 mg tablet is used for prophylaxis of deep vein thrombosis after hip or knee replacement surgery and, at the same dose, to reduce the risk of recurrent DVT or PE after at least six months of initial anticoagulant treatment; the 2.5 mg tablet, taken with aspirin, is approved to reduce major cardiovascular events in chronic coronary artery disease and peripheral artery disease. M Care Exports sources rivaroxaban from WHO-GMP certified Indian manufacturers as a merchant-exporter; it does not manufacture the product itself.
Administration
Oral. Film-coated tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Rivaroxaban moves through hospital pharmacy procurement, cardiology and vascular surgery formulary committees, national tender desks and licensed pharmaceutical importers and wholesalers across the UK and EU, the Gulf and wider GCC, Africa, Latin America, Southeast Asia and the CIS. Anticoagulation is a standing line on most hospital formularies, so repeat institutional buyers and distributors building a cardiovascular portfolio account for most enquiries, alongside importers assembling a tender submission that needs a specific strength, in either branded or generic presentation, matched to their own country's approved product register. India is the country of manufacture only; it is not a market M Care serves.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on rivaroxaban.
A reviewing pharmacist checks four things specific to rivaroxaban before it moves onto a formulary. First, the food-effect split: the 15 mg and 20 mg tablets require administration with food for adequate bioavailability, while the 2.5 mg and 10 mg strengths do not, so patient information leaflets and dispensing labels must match the strength actually supplied. Second, renal dosing, which is not uniform: adjustment thresholds differ across the atrial fibrillation, VTE and vascular-protection indications, and the label advises against use below a CrCl of 15 mL/min. Third, drug interaction exposure through CYP3A4 and P-glycoprotein, which flags combination therapy with strong inhibitors or inducers for review. Fourth, reversal and bleeding-management protocol on the receiving formulary, since specific factor Xa reversal availability and labelling differ by country and hospital. A crush-and-mix administration option (with applesauce, or in water via nasogastric tube) exists for patients who cannot swallow tablets whole, which some tender specifications ask about directly.
The documentation pack a regulator actually asks for.
M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself; those belong to the Indian manufacturing sites we source from, and we confirm site-specific GMP status against the buyer's requirement before quoting. M Care's own credentials are ISO 9001:2015 and a CDSCO export licence. Because rivaroxaban's patent and generic-availability status differs by strength and by destination country, the documentation pack starts with confirming which strength, and which presentation, the buyer's own market registration permits before a formal quote is built. The standard pack includes certificate of pharmaceutical product or free-sale certificate, site GMP certificate, certificate of analysis per batch, stability data, and product-specific dossier support (CTD or eCTD format as required) for the buyer's own regulatory submission. Buyers registering the 10 mg, 15 mg or 20 mg strengths into a market where originator exclusivity is still active should confirm their own freedom-to-operate position; that determination sits with the buyer's regulatory and legal counsel, not with M Care.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Boxed warning: premature discontinuation of rivaroxaban increases the risk of thrombotic events
Boxed warning: epidural or spinal hematoma risk in patients undergoing neuraxial anesthesia or spinal puncture
Prescription-only oral anticoagulant; this page is written for regulatory affairs, procurement and tender audiences, not patient dosing guidance
Patent and generic-availability status differs by strength (2.5mg versus 10/15/20mg) and by destination country; buyer must confirm freedom-to-operate and registration status before commercial supply into any patent-active market
Renal dosing is indication-specific and not uniform across strengths; label advises against use below CrCl 15 mL/min
CYP3A4 and P-glycoprotein interaction potential with strong inhibitors or inducers
Adjacent lines procurement desks order alongside rivaroxaban.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for rivaroxaban.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Rivaroxaban supply, the specific questions.
Is rivaroxaban supplied as the Xarelto brand or as a generic?
We reference Xarelto because that is how buyers search and how tender specifications are written, but we can source both the originator brand and licensed generic lines, in the strength and market your registration calls for. The final quote is built against your own registered label and destination approval, not a generic template.
Why does rivaroxaban come in a 2.5 mg strength that is dosed differently from the rest?
The 2.5 mg tablet is the vascular-protection dose, taken twice daily with low-dose aspirin, approved to reduce major cardiovascular events in chronic coronary artery disease and peripheral artery disease. The 15 mg and 20 mg tablets are dosed for stroke prevention in atrial fibrillation and for acute venous thromboembolism treatment, and the 10 mg tablet is dosed for VTE prevention after hip or knee replacement surgery and, separately, for reducing the risk of recurrent VTE after initial treatment. They are different indications on the same molecule, not interchangeable strengths of one dose.
Does patent status affect which rivaroxaban strengths M Care can supply?
It affects which strengths can be supplied as generic into a given market. In the United States, the 2.5 mg strength cleared generic entry in March 2025 while the 10 mg, 15 mg and 20 mg strengths remain under originator exclusivity there. Patent and exclusivity timelines differ by country, so we confirm the buyer's own destination position before quoting a specific strength or presentation.
What is the main safety information buyers should know about rivaroxaban?
Rivaroxaban carries two boxed warnings: premature discontinuation increases the risk of thrombotic events, and epidural or spinal hematoma can occur in patients undergoing neuraxial anesthesia or spinal puncture. Both are standard label information that regulatory affairs teams and prescribers already work with, not a reason to avoid the molecule.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, so it does not hold WHO-GMP or WHO-PQ certification itself. Rivaroxaban is sourced from WHO-GMP certified Indian manufacturing sites, and M Care's own credentials are ISO 9001:2015 and a CDSCO export licence, which we confirm against each buyer's requirement at enquiry.
Do the 15 mg and 20 mg tablets need to be taken with food?
Yes. The approved label requires the 15 mg and 20 mg tablets to be taken with food for adequate absorption, while the 2.5 mg and 10 mg tablets can be taken with or without food. This affects patient information leaflet wording and dispensing labels in the destination market, so it is worth confirming which strength your registration covers.
What documentation accompanies a rivaroxaban shipment?
A standard pack includes a certificate of pharmaceutical product or free-sale certificate, the manufacturing site's GMP certificate, a batch-specific certificate of analysis, stability data, and dossier support in CTD or eCTD format for the buyer's own regulatory submission. Exact requirements are confirmed against the importing country's checklist before shipment.
Which buyers and regions typically order rivaroxaban from M Care?
Hospital pharmacy procurement, cardiology and vascular surgery formulary committees, national tender desks, and licensed importers and wholesalers across the UK and EU, the Gulf and wider GCC, Africa, Latin America, Southeast Asia and the CIS. India is our country of origin, not a market we serve.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.