← Back to Products
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.

Request Technology Transfer Get CTD Template

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 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 Irinotecan 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