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Oncology

Pemetrexed

Alimta®

Pemetrexed is a multi-targeted antifolate used in the treatment of non-small cell lung cancer and malignant pleural mesothelioma. It inhibits multiple folate-dependent enzymes involved in nucleotide synthesis.

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Product Details

Dosage FormIV Injectable (Lyophilized Powder)
Strength100 mg, 500 mg vials
StorageStore at 25°C. Reconstituted solution stable for 24 hours at 2–8°C.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Non-squamous NSCLC (initial treatment with cisplatin; maintenance); malignant pleural mesothelioma (with cisplatin).

Mechanism of Action

Inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), disrupting folate-dependent metabolic processes essential for cell replication.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Pemetrexed 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 Pemetrexed 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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