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Fludarabine 50mg/2mL
Product Overview
| Generic Name | Fludarabine 50mg/2mL |
| Brand Name(s) | Fludara® |
| Category | Antineoplastic / Cancer |
| Form | Lyophilized powder for solution for IV infusion (commonly 50 mg vial); |
| Strength | 50mg vial |
| Therapeutic Class | Purine analogue antimetabolite |
| ATC Code | L01BB05 |
Manufacturing & Regulatory
| Manufacturer | Bayer, Sanofi, Salius, Celon, nest |
| GMP Compliance | WHO-GMP / cGMP-compliant |
| DMF/CEP | FLUDARABINE PHOSPHATE DRUG SUBSTANCE, 44863, 44943 |
| COFEPRIS | 01000054550001 |
| Free Sale Certificate | Available per batch upon request |
Logistics & Export
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C) |
| Incoterms | EXW 30049049 |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | GHS-compliant Safety Data Sheets |
| CTD Summary (PDF) | CTD from originator; generic use abbreviated formats |
Special Notes
Fludarabine (as fludarabine phosphate) is a purine analogue antimetabolite used mainly in adult B-cell chronic lymphocytic leukemia (CLL)