Guselkumab 100mg/mL
Product Overview
| Generic Name | Guselkumab 100mg/mL |
| Brand Name(s) | Tremfya® |
| Category | Antibodies, monoclonal |
| Form | Prefilled pen 100 mg/mL |
| Strength | 100 mg/mL |
| Therapeutic Class | Interleukin-23 (IL-23) inhibitor / immunosuppressant. |
| ATC Code | L04AC16 |
Manufacturing & Regulatory
| Manufacturer | Janssen-Cilag International NV, Biogen |
| 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 Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Upon Request, not publicly posted |
| CTD Summary (PDF) | CTD dossier proprietary; available under commercial agreement/license |
Special Notes
(BIOSIMILAR VERSION OF) 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