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Oncology

Fluorouracil (5-FU)

Adrucil®

Fluorouracil is a pyrimidine analog and antimetabolite that inhibits thymidylate synthase. A cornerstone of GI cancer treatment for decades.

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Product Details

Dosage FormIV Injectable (Solution)
Strength50 mg/mL; 500 mg, 1000 mg, 2500 mg, 5000 mg vials
StorageStore at 15–30°C. Protect from light. Do not refrigerate.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Colorectal cancer; breast cancer; gastric cancer; pancreatic cancer. Often combined with leucovorin and/or oxaliplatin (FOLFOX).

Mechanism of Action

Converted intracellularly to active metabolites that inhibit thymidylate synthase and are incorporated into RNA and DNA, disrupting nucleic acid synthesis.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Fluorouracil (5-FU) 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 Fluorouracil (5-FU) 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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