Inotuzumab ozogamicin 1mg
| Product Overview | |
| Generic Name | Inotuzumab ozogamicin 1mg |
| Brand Name(s) | Besponsa® |
| Form | Lyophilized powder for concentrate for solution for intravenous infusion |
| Strength | 1mg per vial (0.9mg) |
| Therapeutic Class | CD22-directed monoclonal antibody–drug conjugate |
| ATC Code | L01XC26 |
| Manufacturing & Regulatory | |
| Manufacturer | Wyeth Pharma/Pfizer, |
| Country | USA, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 6110.00 |
| 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
Inotuzumab ozogamicin is a CD22-directed antibody–drug conjugate indicated for the treatment of patients with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL)
