Trexall®
High-dose methotrexate is used in oncology for the treatment of ALL, lymphoma, and osteosarcoma. It inhibits dihydrofolate reductase, blocking nucleotide synthesis.
| Dosage Form | IV / SC / IM Injectable |
| Strength | 25 mg/mL; various vial sizes |
| Storage | Store at 20–25°C. Protect from light. |
| Category | Oncology |
| Availability | Available for Transfer |
Acute lymphoblastic leukemia; non-Hodgkin lymphoma; osteosarcoma; primary CNS lymphoma; gestational trophoblastic disease.
Inhibits dihydrofolate reductase (DHFR), blocking the conversion of dihydrofolate to tetrahydrofolate. This disrupts purine and thymidine synthesis, halting DNA replication.
Each Burrard Pharmaceuticals technology transfer package for Methotrexate (Oncology) includes comprehensive documentation and support:
Complete formulation with manufacturing parameters, excipient specifications, and process controls.
Validated methods for assay, impurities, dissolution, and stability-indicating analysis.
Market-ready regulatory dossier sections for a named territory, scoped per programme.
ICH-compliant stability studies (accelerated and long-term) with detailed protocols.
Scale-up procedures, batch records, equipment specifications, and in-process controls.
Direct advisory access to formulation scientists and regulatory specialists throughout 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.