Daratumumab 400mg
| Product Overview | |
| Generic Name | Daratumumab 400mg |
| Brand Name(s) | DARZALEX (IV); DARZALEX FASPRO |
| Form | Solución para infusión IV (concentrado 20 mg/mL) |
| Strength | IV: 400 mg/20 mL |
| Therapeutic Class | Anticuerpo monoclonal anti-CD38 para mieloma múltiple |
| ATC Code | L01XC24 |
| Manufacturing & Regulatory | |
| Manufacturer | Janssen-Cilag International N.V. |
| Country | Bélgica, (Biosimilar India pipeline) |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 010.000.6208.00 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
| 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 | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Daratumumab es un anticuerpo IgG1κ anti-CD38 indicado en mieloma múltiple (combinaciones con IMiD/PI/dexa; líneas iniciales y recaídas).
