Daunorubicin 20mg
| Product Overview |
| Generic Name | Daunorubicin 20mg |
| Brand Name(s) | Daunohal; Cerubidine; Daunomycin; Daunotec; Dauneon; Daunomac; Vyxeos (liposomal form); DaunoXome |
| Form | Lyophilized powder for IV injection; vial form |
| Strength | 20 mg per vial (≈21.4 mg hydrochloride salt equivalent) |
| Therapeutic Class | Anthracycline topoisomerase II inhibitor |
| ATC Code | L01DB07 |
| Manufacturing & Regulatory |
| Manufacturer | Halsted Pharma, Pfizer/Actavis, Cipla, Neon, Admac |
| Country | India, Italy |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Type II DMFs |
| COFEPRIS | Pending |
| Free Sale Certificate | Yes |
| Logistics & Export |
| MOQ | 10 units |
| Shelf Life | 24 Months |
| Storage | 20–25 °C, protect from light; reconstitute prior to administration |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation |
| Certificate of Analysis (COA) | Provided per batch |
| SDS | Upon Request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Indications & Usage: Daunorubicin is indicated for induction of remission in acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), and certain leukemic phases of CML; administered IV under specialist supervision (often combined with cytarabine); liposomal variant (Vyxeos) approved for therapy-related AML or AML with myelodysplasia-related changes; off-label use in Kaposi’s sarcoma; mechanism: DNA intercalation and topoisomerase II inhibition leading to cytotoxicity
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