Basiliximab 20mg
| Product Overview | |
| Generic Name | Basiliximab 20mg |
| Brand Name(s) | Simulect® |
| Form | Powder (lyophilisate) and solvent for solution for injection or infusion |
| Strength | 20 mg in 5 mL |
| Therapeutic Class | Interleukin-2 receptor (CD25) antagonist; interleukin inhibitor; immunosuppressive |
| ATC Code | L04AC02 |
| Manufacturing & Regulatory | |
| Manufacturer | Novartis Pharma AG, Novartis India LTD |
| Country | Switzerland, USA, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 352M98SSAIV |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 36 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 | CTD available to regulators; summary available to qualified partners |
Description
Basiliximab is a chimeric (murine/human) IgG1κ monoclonal antibody directed against the interleukin-2 receptor α-chain (CD25) on activated T-lymphocytes. It is indicated for the prophylaxis of acute rejection in de-novo renal transplantation
