Factocel IX 250iu
| Product Overview | |
| Generic Name | Factocel IX 250iu |
| Brand Name(s) | Freeze Dried Human Coagulation Factor IX IP/EP |
| Form | Injection (vial) |
| Strength | 250 IU / 600 IU Factor IX |
| Therapeutic Class | Coagulation factor IX concentrate for Hemophilia B |
| ATC Code | B02BD01 |
| Manufacturing & Regulatory | |
| Manufacturer | Intas Pharmaceuticals Ltd |
| Country | India |
| GMP Compliance | WHO-GMP certified facility |
| DMF/CEP | Not publicly available |
| COFEPRIS | Clave number to request |
| 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 | Provided under NDA/purchase with fee |
Description
Indications & Usage: Used in prophylaxis and treatment of bleeding episodes in Hemophilia B; also in surgery/trauma settings
