Finished-dose partner supply and technology transfer. INN: warfarin sodium.
Warfarin is a vitamin K antagonist oral anticoagulant. Despite the emergence of DOACs, it remains essential for patients with mechanical heart valves.
Burrard does not manufacture in-house. Finished-dose manufacture is placed with a qualified partner GMP site named per programme under CDA. No product FDA, Health Canada, or EMA approval is claimed on this page. Coumadin® and other brands are referenced for identification only and are not Burrard trademarks or Burrard-branded goods.
| Dosage Form | Oral Tablet |
| Strength | 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, 10 mg |
| Storage | Store at 15–30°C. Protect from light. |
| Category | Cardiovascular |
| Availability | Available for Transfer |
| Finished-dose strengths | Confirmed under CDA / quality pack for the named partner configuration. The strength list is a technology-transfer catalogue, not a finished-dose export SKU list. |
Venous thromboembolism; atrial fibrillation; mechanical heart valves; post-MI thromboprophylaxis.
Inhibits vitamin K epoxide reductase (VKORC1), preventing the regeneration of vitamin K and reducing hepatic synthesis of clotting factors II, VII, IX, and X.
Each Burrard Pharmaceuticals technology transfer package for Warfarin includes comprehensive documentation and support:
Complete formulation with manufacturing parameters, excipient specifications, and process controls.
Validated methods for assay, impurities, dissolution, and stability-indicating analysis.
Market-ready regulatory dossier sections for a named territory, scoped per programme.
ICH-compliant stability studies (accelerated and long-term) with detailed protocols.
Scale-up procedures, batch records, equipment specifications, and in-process controls.
Direct advisory access to formulation scientists and regulatory specialists throughout transfer.
No. Burrard does not manufacture in-house. Finished-dose manufacture is placed with a qualified partner GMP site named per programme under CDA. Certificates for the named site are shared via the quality pack.
No product FDA, Health Canada, or EMA approval is claimed on this page. Destination-market marketing authorisation is typically held by the local MAH or importer. Partner-site or API evidence is not the same as product approval.
Partner supply coordinates finished-dose product from a named partner GMP site for qualified importers and distributors. Technology transfer provides know-how and documentation for partners who manufacture or register under their own arrangements.
Strengths and packs for finished-dose supply are confirmed under CDA and in the quality pack for the named partner configuration. Catalogue strength lists used for technology transfer are Availability for Transfer only and are not an automatic finished-dose export SKU list.
Typical contents, as available and confirmed under CDA, include batch CoA, site GMP evidence for the named partner site, API programme documentation as applicable, and dossier-format availability notes.
No. Burrard does not hold bioequivalence claims for this programme.
Email bd@burrardpharma.com with your company, territory, and whether you need finished-dose supply, technology transfer, or both. Burrard will outline CDA and next steps.
Scope and timing for the complete know-how package are confirmed in writing after a confidentiality agreement. Book a consultation to discuss your specific requirements.