Etanercept 50mg Vial
| Product Overview | |
| Generic Name | Etanercept 50mg Vial |
| Brand Name(s) | Enbrel (originator); biosimilars: Benepali, Brenzys, Erelzi |
| Form | Vial, Solution for subcutaneous injection |
| Strength | 50 mg |
| Therapeutic Class | Anti‑tumor necrosis factor agent for autoimmune disorders |
| ATC Code | L04AB01 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen; outside US/Pfizer; Biosimilar manufacturers |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Manufacturer-specific, not public |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/FOB/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 | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indications & Usage: Etanercept is indicated for moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis. Mechanism: a TNF‑alpha decoy receptor fusion protein that binds & neutralizes soluble TNF
