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Globucel-SC 16.5
Product Overview
| Generic Name | Globucel-SC 16.5 |
| Brand Name(s) | Human Normal Immunoglobulin for Subcutaneous Use Solution IP/EP |
| Category | Blood Products / Hemoderivatives |
| Form | Vial |
| Strength | 16.5% IgG (10 mL vial) |
| Therapeutic Class | SC human normal IgG (PID, autoimmune) |
| ATC Code | J06BA01 |
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 upon request |
| CTD Summary (PDF) | Available upon paid request |
Special Notes
Indications & Usage: SC IgG for primary/secondary immunodeficiencies, neuromuscular & autoimmune disorders