Infliximab 100mg/mL
Product Overview
| Generic Name | Infliximab 100mg/mL |
| Brand Name(s) | Remicade, Inflectra, Renflexis, Ixifi, Flixabi |
| Category | Antibodies, monoclonal |
| Form | Injectable Solution (IV infusion) |
| Strength | 100 mg/20 mL |
| Therapeutic Class | Immunosuppressant, Anti-TNF (Tumor Necrosis Factor) Therapy |
| ATC Code | L04AB02 |
Manufacturing & Regulatory
| Manufacturer | Janssen Biotech (Remicade) |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Type II |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Available from supplier on request |
Logistics & Export
| MOQ | 10 units |
| Shelf Life | 18-24 months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Yes—lot-specific Certificate of Analysis |
| SDS-Safety Data Sheet (PDF) | Upon Request, not publicly posted |
| CTD Summary (PDF) | CTD from originator; generic use abbreviated formats |
Special Notes
Use and Indications for Infliximab: Infliximab is a chimeric monoclonal antibody indicated for the treatment of autoimmune inflammatory disorders, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. It targets and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammation and immune-mediated tissue damage.