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Oncology

Docetaxel

Taxotere®

Docetaxel is a semi-synthetic taxane that disrupts microtubule dynamics. Used in breast, prostate, gastric, head and neck, and non-small cell lung cancers.

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Product Details

Dosage FormIV Injectable (Concentrate for Solution)
Strength20 mg/mL, 80 mg/4mL
StorageStore at 2–25°C. Protect from light.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Breast cancer; NSCLC; hormone-refractory prostate cancer; gastric adenocarcinoma; head and neck squamous cell carcinoma.

Mechanism of Action

Promotes assembly of microtubules and inhibits their depolymerization, stabilizing them and disrupting the microtubule dynamics required for mitotic cell division.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Docetaxel 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 Docetaxel 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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