Alemtuzumab 12mg/1.2mL
| Product Overview | |
| Generic Name | Alemtuzumab 12mg/1.2mL |
| Brand Name(s) | Lemtrada |
| Product Type | Biosimilar |
| Form | Sterile IV infusion concentrate / injection vial. |
| Strength | 12 mg/1.2 mL, single-dose vial |
| Therapeutic Class | Anti-CD52 monoclonal antibody; lymphocyte-depleting immunotherapy. |
| ATC Code | L04AG06 |
| Manufacturing & Regulatory | |
| Manufacturer | Genzyme, Intas, Sanofi |
| Country | USA, Canada, India |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.6205.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Alemtuzumab binds CD52 on mature lymphocytes and causes lymphocyte depletion. Lemtrada is a lower-strength branded presentation used for relapsing multiple sclerosis, with significant autoimmune, infection, and infusion-reaction monitoring requirements.
