Golimumab 50mg
| Product Overview | |
| Generic Name | Golimumab 50mg |
| Brand Name(s) | Simponi (SC); Simponi Aria (IV) |
| Form | single-dose vial for intravenous infusion |
| Strength | 50 mg/4 mL (12.5 mg/mL) single-dose vial |
| Therapeutic Class | TNF-α inhibitor (immunosuppressant / disease-modifying biologic) |
| ATC Code | L04AB06 |
| Manufacturing & Regulatory | |
| Manufacturer | Janssen-Cilag International NV |
| Country | Netherlands |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Pending |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C), do not return to fridge |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Available from manufacturer |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Golimumab is a TNF-α inhibitor indicated for adults with moderately to severely active rheumatoid arthritis (with MTX), psoriatic arthritis, ankylosing spondylitis, and moderately to severely active ulcerative colitis;
