Darbepoetin alfa 100 µg
| Product Overview | |
| Generic Name | Darbepoetin alfa 100 µg |
| Brand Name(s) | Aranesp |
| Form | Injection (solution) |
| Strength | 100 µg |
| Therapeutic Class | Recombinant glycoprotein, anemia treatment |
| ATC Code | B03XA02 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen (Aranesp) |
| Country | USA, India |
| 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 | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
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
