Durvalumab 120mg

Durvalumab 120mg

Product Overview

Generic NameDurvalumab 120mg
Brand Name(s)IMFINZI®
CategoryAntineoplastic / Cancer
FormConcentrate for solution for intravenous infusion (injection, solution)
Strength120mg / 2.4mL (50mg/mL)
Therapeutic ClassPD-L1 immune checkpoint inhibitor; antineoplastic monoclonal antibody (IgG1κ)
ATC CodeL01FF03

Manufacturing & Regulatory

ManufacturerAstraZeneca
GMP ComplianceWHO-GMP
DMF/CEPNot publicly disclosed
COFEPRIS010.000.6323.00
Free Sale CertificateYes, available as COPP/CPP

Logistics & Export

MOQ5 units
Shelf Life36 months
Storage2–8 °C, protect from light
IncotermsEXW/FOB/CIF negotiable
Lead Time7 - 10 Business Days

Documentation Available Upon Request

Certificate of Analysis (PDF)Supplied per batch upon request
SDS-Safety Data Sheet (PDF)Upon Request, not publicly posted
CTD Summary (PDF)CTD available to regulators; summary available to qualified partners

Special Notes

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)