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.
| Dosage Form | IV Injectable (Lyophilized Powder / Solution) |
| Strength | 200 mg, 1 g, 2 g vials |
| Storage | Store at 20–25°C. Reconstituted solution stable for 24 hours at controlled room temperature. |
| Category | Oncology |
| Availability | Available for Transfer |
Pancreatic adenocarcinoma; NSCLC (with cisplatin); metastatic breast cancer (with paclitaxel); ovarian cancer (with carboplatin); bladder cancer (with cisplatin).
Nucleoside analog that is phosphorylated intracellularly to active diphosphate and triphosphate forms. The triphosphate is incorporated into DNA, leading to chain termination and apoptosis.
Each Burrard Pharmaceuticals technology transfer package for Gemcitabine 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.