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Oncology

Irinotecan

Camptosar®

Irinotecan is a topoisomerase I inhibitor used for the treatment of metastatic colorectal cancer. It prevents DNA religation during replication, inducing strand breaks.

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Product Details

Dosage FormIV Injectable (Solution)
Strength20 mg/mL; 40 mg, 100 mg, 300 mg vials
StorageStore at 15–30°C. Protect from light.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Metastatic colorectal cancer (first-line with 5-FU/leucovorin, or after failure of 5-FU-based therapy).

Mechanism of Action

Binds to topoisomerase I-DNA complex and prevents religation of single-strand breaks. The resulting double-strand DNA damage leads to apoptosis.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Irinotecan 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 Irinotecan 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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