← Back to Products
Cardiovascular

Fondaparinux

Arixtra®

Fondaparinux is a synthetic pentasaccharide that selectively inhibits Factor Xa via antithrombin III. Used for DVT/PE prophylaxis and treatment.

Request Technology Transfer Get CTD Template

Product Details

Dosage FormSC Injectable (Prefilled Syringe)
Strength2.5 mg, 5 mg, 7.5 mg, 10 mg
StorageStore at 25°C. Do not freeze.
CategoryCardiovascular
AvailabilityAvailable for Transfer

Indication

DVT prophylaxis in hip fracture, hip/knee replacement, and abdominal surgery; treatment of DVT and PE.

Mechanism of Action

Selective Factor Xa inhibitor that binds to antithrombin III, catalyzing Factor Xa neutralization without directly affecting thrombin.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Fondaparinux includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Fondaparinux Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

Book 120-Min Review Subscribe to Intelligence — $499/mo