Fibrogen-I 0.5g
Product Overview | |
Generic Name | Fibrogen-I 0.5g |
Brand Name(s) | Freeze Dried Powder Human Fibrinogen EP |
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 |
Country | India |
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 | |
Certificate of Analysis (COA) | Provided by manufacturer |
SDS | Available on request |
CTD Summary | Available upon paid request (NDA or PO) |
Description
Indications & Usage: Indicated for treatment of congenital fibrinogen deficiency (afibrinogenemia/hypofibrinogenemia), acute bleeding support, surgical prophylaxis