Darbepoetin alfa 40 µg
Product Overview
| Generic Name | Darbepoetin alfa 40 µg |
| Brand Name(s) | Aranesp |
| Category | Blood Products / Hemoderivatives |
| Form | Injection (solution) |
| Strength | 40 µg |
| Therapeutic Class | Recombinant glycoprotein, anemia treatment |
| ATC Code | B03XA02 |
Manufacturing & Regulatory
| Manufacturer | Amgen (Aranesp) |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Type II |
| COFEPRIS | Registered in Mexico, Batch-specific specific clave unknown |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 10 Units |
| Shelf Life | 36 months |
| Storage | Cool & dry place; 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) | Upon Request |
| CTD Summary (PDF) | CTD from originator; generic use abbreviated formats |
Special Notes
Indications & Usage Darbepoetin alfa is a long‑acting recombinant erythropoiesis‑stimulating agent indicated for treatment of anemia associated with chronic kidney disease (dialysis and non‑dialysis), and chemotherapy‑associated anemia in cancer patients. It stimulates red blood cell production via Epo receptor activation and has a longer half‑life compared to epoetin alfa Erythropoiesis‑stimulating agent (ESA