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Oncology

Methotrexate (Oncology)

Trexall®

High-dose methotrexate is used in oncology for the treatment of ALL, lymphoma, and osteosarcoma. It inhibits dihydrofolate reductase, blocking nucleotide synthesis.

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Product Details

Dosage FormIV / SC / IM Injectable
Strength25 mg/mL; various vial sizes
StorageStore at 20–25°C. Protect from light.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Acute lymphoblastic leukemia; non-Hodgkin lymphoma; osteosarcoma; primary CNS lymphoma; gestational trophoblastic disease.

Mechanism of Action

Inhibits dihydrofolate reductase (DHFR), blocking the conversion of dihydrofolate to tetrahydrofolate. This disrupts purine and thymidine synthesis, halting DNA replication.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Methotrexate (Oncology) 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 Methotrexate (Oncology) Technology Transfer?

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

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