Guselkumab
| Product Overview | |
| Generic Name | Guselkumab |
| Brand Name(s) | Tremfya® |
| Form | Prefilled pen 100 mg/mL |
| Strength | 100 mg/mL; 200 mg/2 mL |
| Therapeutic Class | Interleukin-23 (IL-23) inhibitor / immunosuppressant. |
| ATC Code | L04AC16 |
| Manufacturing & Regulatory | |
| Manufacturer | Janssen-Cilag International NV, Biogen |
| Country | Netherlands, Belgium, USA, Ireland |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Manufacturer-specific, not public |
| COFEPRIS | 010.000.7004.00/01, 290M2018 SSA IV |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD dossier proprietary; available under commercial agreement/license |
Description
Guselkumab is a fully human IgG1λ monoclonal antibody that selectively binds the p19 subunit of IL-23. It is indicated for adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, and—in recent label expansions—moderately to severely active ulcerative colitis and Crohn’s disease
