Eculizumab
| Product Overview | |
| Generic Name | Eculizumab |
| Brand Name(s) | Soliris, Bkemv, Epysqli |
| Form | concentrate for solution for infusion (IV use) single-dose vial |
| Strength | 300 mg/30 mL (10 mg/mL) per vial |
| Therapeutic Class | Terminal complement (C5) inhibitor monoclonal antibody |
| ATC Code | L04AJ01 |
| Manufacturing & Regulatory | |
| Manufacturer | Alexion, Amgen |
| Country | USA, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | medicamento huérfano |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Available from manufacturer |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Eculizumab is a C5 complement inhibitor indicated for PNH (hemolysis reduction), aHUS (inhibition of complement-mediated TMA), AChR-positive refractory gMG in adults, and AQP4-positive NMOSD.
