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Erythropoietin alpha 2000iu
Product Overview
| Generic Name | Erythropoietin alpha 2000iu |
| Brand Name(s) | EpoGen, Procrit, Retacrit (biosimilar), Epoetin Alfa Hexal |
| Category | Biologics / Biopharmaceuticals |
| Form | Solution for inj (vial, pre‑filled syringes) |
| Strength | 2,000 IU/mL |
| Therapeutic Class | Erythropoiesis-Stimulating Agent (ESA) |
| ATC Code | B03XA01 |
Manufacturing & Regulatory
| Manufacturer | Amgen, Sandoz other global biosimilar producers |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 10 Units |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C) |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary (PDF) | Full CTD dossier proprietary; available under commercial agreement/license |
Special Notes
Indications & Usage: Erythropoietin alpha is indicated for treatment of symptomatic anemia due to chronic kidney disease (including dialysis and non‑dialysis patients), anemia in patients receiving chemotherapy for non‑myeloid malignancies, reduction of allogeneic blood transfusion in surgery predonation or orthopedic surgery programs, and anemia in low‑ or intermediate‑risk myelodysplastic syndromes. It stimulates erythropoiesis via binding to EPO receptor on erythroid progenitors