Pegfilgrastim 6 mg
Product Overview
| Generic Name | Pegfilgrastim 6 mg |
| Brand Name(s) | Neulasta, Fulphila, Pelgraz |
| Category | Blood Products / Hemoderivatives |
| Form | Prefilled Syringe for subcutaneous injection |
| Strength | 6 mg per 0.6 mL |
| Therapeutic Class | Recombinant human G-CSF, PEGylated long‑acting |
| ATC Code | L03AA13 |
Manufacturing & Regulatory
| Manufacturer | Various Biosimilar mfg's |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 010.000.5452.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
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 Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Upon Request, not publicly posted |
| CTD Summary (PDF) | CTD proprietary; available under commercial agreement/license |
Special Notes
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