Bendamustine 100mg/4mL
| Product Overview | |
| Generic Name | Bendamustine 100mg/4mL |
| Brand Name(s) | Treanda, Ribomustin, Cytostasan |
| Form | 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.) |
| Country | India |
| 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 Mexico |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Yes—for API and finished product |
| CTD Summary | Upon Request |
Description
Indications and Use: 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.
