Warfarin Sodium Tablets Exporter and Supplier from India
M Care Exports supplies warfarin sodium tablets in 1mg, 2mg, 3mg and 5mg colour coded strengths from Indian WHO GMP and EU GMP sites to hospital pharmacies, MoH tender authorities and NGO anticoagulation programmes across the UK, GCC, African and Southeast Asian markets. Warfarin is on the 23rd WHO Model List of Essential Medicines (2023) and remains first line in mechanical heart valves, antiphospholipid syndrome and where direct oral anticoagulants are unsuitable.
Warfarin sodium at a glance
Molecule
Warfarin sodium, racemic R and S coumarin derivative. INN warfarin. CAS 129-06-6. ATC B01AA03. Vitamin K antagonist acting on VKORC1 to reduce functional factors II, VII, IX and X.
Strengths supplied
1mg, 2mg, 3mg and 5mg scored tablets. Colour coded in line with UK and Commonwealth dispensing convention to reduce strength selection error in pharmacy and at home.
Pack formats
Blister of 28 tablets in cartons of 28, 30 and 100. HDPE amber bottles of 30, 100, 500 and 1000 tablets with desiccant. Hospital bulk packs and unit dose strips available for tender.
Regulatory dossiers
CTD format dossier available. Each shipment carries CoA per batch, CPP from Indian competent authority, BMR summary on request, ICH zone IVa stability and 24 month shelf life on validated formulations.
Clinical role
First line oral anticoagulant in mechanical heart valves, antiphospholipid syndrome and severe renal impairment. NICE NG196 recommended alternative where DOACs are unsuitable. Requires INR monitoring.
Procurement profile
Generic and off patent for over 60 years. Tender pricing is fractions of a cent per tablet at MoH volume. Largest tender volumes today are in African and Southeast Asian public-sector anticoagulation programmes.
Warfarin sodium tender and contract supply by region
M Care Exports holds active supply lanes for warfarin sodium tablets into four regional buyer groups, each with its own dossier expectations, language requirements and pack convention.
UK NHS and Crown Dependencies
Supply into UK wholesalers and Crown Dependency hospital groups against MHRA licensed importer arrangements. Artwork to MHRA Best Practice Guidance, Braille on cartons, blue 3mg and pink 5mg colour convention, FMD compliant 2D Datamatrix until UK national scheme is finalised.
GCC and MENA tenders
Tender response for SFDA, MOHAP, MOH Kuwait, NUPCO, Bahrain SQH and Oman MoH frameworks. Arabic English bilingual artwork, halal sourced lactose where required, CPP with SFDA legalisation and HOKA shipment documents.
African public-sector and NGO
Supply into Ghana NHIS, Kenya KEMSA, Nigeria FMoH, Ethiopia EPSS, Zambia ZAMMSA, Uganda NMS and Francophone Africa central medical stores. Warfarin is heavily used in rheumatic heart disease populations. WHO PQ standard documentation, French and Portuguese leaflets where required.
EU, LATAM and Southeast Asia
EU MAH partnered supply with EU GMP site origin and QP release. LATAM supply with ANVISA, INVIMA and DIGEMID dossier alignment. SEA supply into Philippines DOH, Vietnam MoH and Sri Lanka SPC tender frameworks with serialisation per country.
Pharmacist procurement note on warfarin
Warfarin is the most pharmacovigilance intensive oral anticoagulant on the market and remains so despite the global shift toward direct oral anticoagulants. Procurement teams should plan supply with the same care as the clinical team plans monitoring. The defining feature of warfarin therapy is dose individualisation against the International Normalised Ratio, with target ranges set by the prescriber for the specific indication. Per NICE NG196 for atrial fibrillation and NICE NG158 for venous thromboembolic disease, the conventional adult target is 2.0 to 3.0, while mechanical valves and recurrent thromboembolism on therapeutic anticoagulation can require higher ranges such as 2.5 to 3.5. Always defer to the prescriber and the local SmPC, and ensure your warfarin packs and patient information leaflets carry the relevant national guidance reference. Drug interactions are extensive. Warfarin is metabolised by CYP2C9, CYP1A2 and CYP3A4, and is sensitive to a broad range of antibiotics including metronidazole, ciprofloxacin, co-trimoxazole and macrolides, antifungals of the azole class, amiodarone, NSAIDs through pharmacodynamic mechanisms, and many traditional and herbal products including St John's wort and high dose cranberry. Food interactions matter equally. Vitamin K rich foods such as kale, spinach, broccoli and green tea can blunt anticoagulant effect when introduced or withdrawn abruptly. Patient education materials supplied with each pack should reinforce dietary consistency rather than restriction. Bridging anticoagulation around invasive procedures is a common reason for short term parenteral cover with low molecular weight heparin, and hospital pharmacies frequently co-tender warfarin with enoxaparin or dalteparin to support perioperative protocols. Reversal of warfarin anticoagulation is well established and an advantage over direct oral anticoagulants in resource limited settings. Oral or intravenous vitamin K is used for non urgent over anticoagulation, prothrombin complex concentrate provides rapid factor replacement in major bleeding, and fresh frozen plasma is available where PCC is not stocked. The choice of warfarin over a direct oral anticoagulant is increasingly driven by mechanical valves, antiphospholipid syndrome, end stage renal disease, cost constraints in public-sector tenders, and the availability of INR point of care testing. M Care Exports supports each consignment with batch level CoA, photostability data, and a pharmacovigilance contact in line with importer country requirements.
Warfarin sodium regulatory and quality dossier
Warfarin tenders are won on dossier completeness as much as on price. Every consignment from M Care Exports ships with a numbered documentation pack matched to the importer country requirement.
Manufacturing GMP
Indian manufacturing sites hold WHO GMP from the State Licensing Authority, with EU GMP and PIC/S inspection records available for premium markets. Site master files, plant layout and validation summaries are shared under NDA.
Product specification
FPP specification aligned to BP, EP or USP monograph per buyer preference. Specification covers assay 95 to 105 percent of label, related substances per Ph Eur 2.2.29, dissolution per USP 711 and microbial limits per Ph Eur 2.6.12.
Stability and shelf life
ICH zone IVa accelerated and long term stability on validated formulations supports 24 month shelf life at 30 degrees Celsius and 65 percent relative humidity. Stability data is available in tabular and graphical form for dossier filing.
CoA and CPP
Certificate of Analysis issued per batch by the manufacturer QC and counter signed by exporter QA where required. CPP issued by Indian competent authority in WHO format with apostille or embassy legalisation as required.
Pharmacovigilance
Pharmacovigilance system master file summary, qualified person contact, ICSR reporting workflow and PSUR submission schedule are documented and shared with the importer MAH or distributor.
Serialisation and artwork
2D Datamatrix serialisation per importer country scheme including KSA SFDA Tatmeen, UAE Tatmeen, EU FMD legacy where applicable, and country specific blister and carton artwork with Braille, leaflet languages and barcode placement.
Related cardiovascular molecules and services
Procurement teams typically co-tender warfarin with rate and rhythm control agents, antihypertensives and lipid lowering therapy. Common companion molecules and supporting services are below.
Amlodipine besylate tablets
Calcium channel blocker for hypertension and stable angina. 5mg and 10mg tablets. WHO EML listed. Frequently co-tendered with warfarin in cardiology outpatient programmes.
Losartan potassium tablets
Angiotensin II receptor blocker for hypertension and renal protection. 25mg, 50mg and 100mg strengths. WHO EML listed. Common in atrial fibrillation patients on warfarin.
Metoprolol tartrate and succinate
Beta blocker for rate control in atrial fibrillation, heart failure and post myocardial infarction. Tartrate 25/50/100mg IR and succinate XR 25/50/100/200mg.
Bisoprolol fumarate tablets
Highly cardioselective beta blocker for HFrEF, hypertension and angina. 1.25mg, 2.5mg, 5mg and 10mg strengths. Frequently co-prescribed with warfarin in heart failure with atrial fibrillation.
GCC tender response service
End to end tender response for SFDA, NUPCO, MOHAP, MOH Kuwait and Bahrain SQH frameworks. Dossier translation, CPP legalisation, sample shipment, financial bid preparation and post award supply.
EU GMP import service
EU MAH partnered supply from EU GMP sites with QP release, artwork management, FMD legacy serialisation, leaflet translation and importer compliance across EU 27 markets.
From enquiry to landed shipment in five steps
- Buyer brief and qualification. Share country, indication, target strengths, monthly demand, target landed price and tender deadline. We confirm exporter eligibility for your destination and route the enquiry to the matched manufacturing partner.
- Dossier and sample dispatch. CoA, CPP, GMP certificate, finished product specification, stability summary and pack artwork are shared within 48 hours. Physical samples are couriered against pro forma sample invoice for regulatory submission and bioequivalence reference.
- Commercial offer and contract. Firm price on CIP, CIF or DDP per INCOTERMS 2020, payment via 100 percent LC at sight or DA 90 days for vetted MoH buyers. Contract signed with split delivery schedule for tender awards above 6 months.
- Production, QC release and pre-shipment. Batch manufactured to importer artwork, serialised per country scheme, QC release against BP, EP or USP monograph. Pre-shipment inspection by importer or third party where required.
- Shipment and post-award support. Sea LCL, sea FCL or air per buyer choice. Documentation pack couriered ahead of vessel. Pharmacovigilance reporting, batch recall protocol and re-tender support continue for the contract duration.
Warfarin sodium procurement questions
Why is warfarin still tendered when direct oral anticoagulants are available?
Warfarin remains first line for mechanical heart valve prostheses, antiphospholipid syndrome with triple antibody positivity, severe renal impairment including dialysis, and any clinical context where the prescriber wants reversibility with vitamin K, prothrombin complex concentrate or fresh frozen plasma. NICE NG196 lists warfarin as the recommended alternative where DOACs are contraindicated or unsuitable. Warfarin is also a fraction of the per patient cost of DOACs, which keeps it standard of care across African and Southeast Asian public-sector anticoagulation programmes where rheumatic heart disease and mechanical valve replacement populations are large.
Which strengths and pack sizes do you supply?
Standard supply is 1mg, 2mg, 3mg and 5mg scored tablets, colour coded to UK and Commonwealth dispensing convention. Blister packs of 28 in cartons of 28, 30 or 100 tablets, HDPE amber bottles of 30, 100, 500 and 1000 tablets with desiccant, and unit dose hospital strips. Other strengths including 2.5mg, 4mg and 10mg can be supplied against tender award with a minimum order quantity confirmed at brief stage.
Is the warfarin sourced from EU GMP or WHO GMP sites?
Both options are available. Default supply for African, Southeast Asian and CIS markets is from Indian WHO GMP sites with State Licensing Authority approval. Supply into UK, EU, GCC premium frameworks and certain LATAM markets is from Indian sites holding active EU GMP certification, with site master file, last EU inspection record and QP declaration shared on request.
How do you handle colour coding to avoid strength confusion?
Tablets are dye coded by strength in line with the convention used by long established UK warfarin brands, with white for 0.5mg and 1mg, brown for 3mg and blue or pink for 5mg per buyer preference. Cartons and blisters carry strength specific colour banding and large strength callouts to reduce dispensing error. Artwork can be adjusted to importer country convention where the local standard differs.
What documentation ships with each consignment?
Each consignment carries a numbered documentation pack covering Certificate of Analysis per batch, Certificate of Pharmaceutical Product in WHO format, manufacturer GMP certificate, finished product specification, stability summary, packing list, commercial invoice, bill of lading or air waybill, and country specific legalisation including apostille, embassy attestation or Chamber of Commerce certification per importer requirement.
Can you support tender response timelines under two weeks?
Yes. Tender response within five working days is the standard for warfarin. We hold ready dossiers for major destination markets including UK, GCC member states, Kenya, Ghana, Nigeria, Ethiopia, Zambia, Uganda, Philippines, Vietnam and Sri Lanka. The escalation path for sub two week tender deadlines is documented at the brief stage with the responsible KAM.
What payment and INCOTERMS do you accept?
Standard terms are CIP, CIF or DDP per INCOTERMS 2020. Payment by irrevocable LC at sight from a first class bank is preferred for first order. DA 60 to 90 days terms are available for vetted MoH buyers and established tender awardees against credit insurance cover. Advance TT against pro forma is accepted for sample shipments and small first orders.
Request a warfarin sodium tender quotation
Share your destination country, indication, strengths and monthly demand. Our cardiovascular desk returns a costed offer with CoA, CPP, GMP certificate and stability summary within 48 working hours.