Romiplostim 500 µg
| Product Overview | |
| Generic Name | Romiplostim 500 µg |
| Brand Name(s) | Nplate, Romy |
| Form | Powder for reconstitution; solution for subcutaneous injection, Vial |
| Strength | 500 µg per vial |
| Therapeutic Class | TPO receptor agonist (peptibody) |
| ATC Code | B02BX04 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen |
| Country | USA, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Under Registration (2025) |
| 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/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 | Full CTD proprietary; available under commercial agreement/license |
Description
Indications & Usage: Romiplostim is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) in adults and children ≥1 year refractory to corticosteroids, immunoglobulins, or splenectomy. Administered weekly subcutaneous injection, starting at 1 µg/kg with dose adjustment based on platelet response. Also investigated for radiation-related thrombocytopenia
