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Factocel VIII 500iu
Product Overview
| Generic Name | Factocel VIII 500iu |
| Brand Name(s) | Dried Human Antiheamophillic Factor VIII IP/EP |
| Category | Blood Products / Hemoderivatives |
| Form | Injection (vial) |
| Strength | 500 IU |
| Therapeutic Class | Coagulation Factor VIII for Hemophilia A |
| ATC Code | B02BD02 |
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 Indian port |
| Lead Time | 2–4 weeks after PO |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Provided by manufacturer upon request |
| SDS-Safety Data Sheet (PDF) | Available on request (plasma-derived |
| CTD Summary (PDF) | Available with NDA or PO + fee |
Special Notes
Indications & Usage: Treats/prevents Hemophilia A bleeding, surgical or trauma-related