Cladribine
| Product Overview | |
| Generic Name | Cladribine |
| Brand Name(s) | Leustatin®, Cladrim®, Litak® |
| Form | Sterile solution for injection, single-dose vial, IV infusion (some labels also allow SC) |
| Strength | 10 mg/10 mL (1 mg/mL) |
| Therapeutic Class | Purine nucleoside analogue; antimetabolite |
| ATC Code | L01BB04 |
| Manufacturing & Regulatory | |
| Manufacturer | Fresenius Kabi India Pvt. Ltd |
| Country | India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | API DMFs exist (Type II US-DMF) |
| COFEPRIS | No specific COFEPRIS clave |
| Free Sale Certificate | Yes, FSC/WHO-CoPP |
| Logistics & Export | |
| MOQ | 10 vials |
| Shelf Life | 24 months |
| Storage | Refrigerated 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 | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indication (injection): Treatment of active Hairy Cell Leukemia; administration by experienced oncology clinician
