Blinatumomab 35 µg
| Product Overview | |
| Generic Name | Blinatumomab 35 µg |
| Brand Name(s) | Blincyto |
| Form | Intravenous lyophilized powder, single dose vial |
| Strength | 35 µg |
| Therapeutic Class | Antineoplastic / Immunotherapy |
| ATC Code | L01FX07 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen Inc. |
| Country | India/USA |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Not visible in public domain; |
| Free Sale Certificate | Available (manufactured in US with international approvals) |
| Logistics & Export | |
| MOQ | 5 vials |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C) do not freeze |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | lead times vary (2–4 weeks) |
| Documentation | |
| Certificate of Analysis (COA) | Yes—from manufacturer |
| SDS | available via manufacturer/distributor |
| CTD Summary | Available under confidentiality; summary upon significant purchase |
Description
(Indications & Usage) Blinatumomab is a CD19/CD3 bispecific T-cell engager (BiTE) indicated for: • MRD-positive or relapsed/refractory CD19+ B‑cell precursor ALL in adults and children ≥1 month • Consolidation therapy during multi‑phase chemotherapy for Philadelphia chromosome-negative B‑ALL
