Pegfilgrastim 6 mg
| Product Overview |
| Generic Name | Pegfilgrastim 6 mg |
| Brand Name(s) | Neulasta, Fulphila, Pelgraz |
| Form | Solution for subcutaneous injection, Vial |
| Strength | 6 mg per 0.6 mL |
| Therapeutic Class | Recombinant human G-CSF, PEGylated long‑acting |
| ATC Code | L03AA13 |
| Manufacturing & Regulatory |
| Manufacturer | Amgen, Various Biosimilar mfg's |
| 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 Units |
| Shelf Life | 36 months |
| Storage | Store at controlled room temperature (approx. 20–25 °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, not publicly posted |
| CTD Summary | CTD proprietary; available under commercial agreement/license |
Description
Indications & Usage: Pegfilgrastim 6 mg SC is administered once per chemotherapy cycle to reduce the incidence and duration of febrile neutropenia in patients receiving myelosuppressive cytotoxic chemotherapy (excluding CML and MDS). It stimulates neutrophil production via G-CSF receptor activation
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