Bendamustine 100mg/4mL
Product Overview
| Generic Name | Bendamustine 100mg/4mL |
| Brand Name(s) | Treanda, Ribomustin, Cytostasan |
| Category | Antineoplastic / Cancer |
| Form | Vial, Injectable, Lyophilized powder for intravenous injection (reconstitute) |
| Strength | 100mg 4 mL |
| Therapeutic Class | Nitrogen mustard alkylating agent (antineoplastic) |
| ATC Code | L01AA09 |
Manufacturing & Regulatory
| Manufacturer | Cephalon/Baxter (now generic via Accord, Apotex, Dr Reddy’s, etc.) |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Type II DMFs |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 25 packs |
| Shelf Life | 24 months |
| Storage | 2–8 °C, protect from light |
| Incoterms | Ex-Works, 30049049 |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Yes |
| SDS-Safety Data Sheet (PDF) | Yes—for API and finished product |
| CTD Summary (PDF) | Upon Request |
Special Notes
Bendamustine is an alkylating agent indicated for the treatment of: Chronic Lymphocytic Leukemia (CLL): As first-line therapy in patients for whom fludarabine-based treatment is not appropriate; and also for Indolent B-cell Non-Hodgkin Lymphoma (NHL): Particularly in patients who have progressed during or within six months of treatment with a rituximab-containing regimen.