Filgrastim 300 µg
| Product Overview | |
| Generic Name | Filgrastim 300 µg |
| Brand Name(s) | Neupogen |
| Form | Single Use Vial, Injection (IV/SC) Sol. |
| Strength | 300 µg/mL |
| Therapeutic Class | Hematopoietic agent (colony-stimulating factor) |
| ATC Code | L03AA02 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP certified |
| DMF/CEP | Biologics file BLA |
| COFEPRIS | 010.000.5432.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 months |
| Storage | 2–8 °C |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes—lot-specific Certificate of Analysis |
| SDS | Upon Request, not publicly posted |
| CTD Summary | Not publicly available as parallel traded molecule |
Description
Filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) indicated to reduce the duration of neutropenia and the risk of infection in patients receiving myelosuppressive chemotherapy, undergoing bone marrow transplantation, or with severe chronic neutropenia. It stimulates the production and activation of neutrophils.
