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Fibrogen-I 0.5g
Product Overview
| Generic Name | Fibrogen-I 0.5g |
| Brand Name(s) | Freeze Dried Powder Human Fibrinogen EP |
| Category | Blood Products / Hemoderivatives |
| Form | Injection (vial) |
| Strength | 0.5 g human fibrinogen |
| Therapeutic Class | Fibrinogen concentrate for congenital fibrinogen deficiency |
| ATC Code | B02BD03 |
Manufacturing & Regulatory
| Manufacturer | Intas Pharmaceuticals Ltd |
| GMP Compliance | WHO-GMP certified facility |
| DMF/CEP | Not publicly available |
| COFEPRIS | Clave pending |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, do not freeze |
| Incoterms | FOB Mumbai/Bangalore |
| Lead Time | 2–4 weeks after PO |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Provided by manufacturer |
| SDS-Safety Data Sheet (PDF) | Available on request |
| CTD Summary (PDF) | Available upon paid request (NDA or PO) |
Special Notes
Indications & Usage: Indicated for treatment of congenital fibrinogen deficiency (afibrinogenemia/hypofibrinogenemia), acute bleeding support, surgical prophylaxis