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Oncology

Oxaliplatin

Eloxatin®

Oxaliplatin is a platinum-based antineoplastic agent used primarily for the treatment of advanced colorectal cancer. It forms interstrand and intrastrand DNA crosslinks, inhibiting DNA replication and transcription.

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Product Details

Dosage FormIV Injectable (Solution for Infusion)
Strength5 mg/mL; 50 mg, 100 mg, 200 mg vials
StorageStore at 20–25°C. Do not freeze. Protect from light.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Advanced colorectal cancer (adjuvant treatment of stage III colon cancer after complete resection; treatment of advanced colorectal cancer with 5-FU/leucovorin).

Mechanism of Action

Forms inter- and intra-strand platinum-DNA crosslinks that inhibit DNA replication and transcription, resulting in cell death via apoptosis.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Oxaliplatin 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 Dossier

Market-ready regulatory dossier sections for a named territory, scoped per programme.

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 Oxaliplatin Technology Transfer?

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.

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