Durvalumab 500mg
| Product Overview | |
| Generic Name | Durvalumab 500mg |
| Brand Name(s) | Imfinzi® |
| Form | Concentrate for solution for intravenous infusion (injection, solution) |
| Strength | 500 mg/10 mL (50 mg/mL) |
| Therapeutic Class | PD-L1 immune checkpoint inhibitor; antineoplastic monoclonal antibody (IgG1κ) |
| ATC Code | L01FF03 |
| Manufacturing & Regulatory | |
| Manufacturer | AstraZeneca |
| Country | EU, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 36 months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Durvalumab is a human IgG1κ monoclonal antibody that targets PD-L1, blocking its interaction with PD-1 and CD80 and thereby restoring antitumor T-cell activity. It is indicated (region-dependent) for unresectable stage III non-small cell lung cancer (NSCLC)
