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Oncology

Gemcitabine

Gemzar®

Gemcitabine is a nucleoside analog used to treat pancreatic cancer, non-small cell lung cancer, bladder cancer, and breast cancer. It is incorporated into DNA, inhibiting DNA synthesis and inducing apoptosis.

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Product Details

Dosage FormIV Injectable (Lyophilized Powder / Solution)
Strength200 mg, 1 g, 2 g vials
StorageStore at 20–25°C. Reconstituted solution stable for 24 hours at controlled room temperature.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Pancreatic adenocarcinoma; NSCLC (with cisplatin); metastatic breast cancer (with paclitaxel); ovarian cancer (with carboplatin); bladder cancer (with cisplatin).

Mechanism of Action

Nucleoside analog that is phosphorylated intracellularly to active diphosphate and triphosphate forms. The triphosphate is incorporated into DNA, leading to chain termination and apoptosis.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Gemcitabine 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 Gemcitabine 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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