Mitoxantrone 2mg/mL
| Product Overview |
| Generic Name | Mitoxantrone 2mg/mL |
| Brand Name(s) | Novantrone (original), Sun’s Oncotron, VHB’s Mitozan (India) |
| Form | Intravenous solution; lyophilized powder for injection (vial) |
| Strength | 2mg/mL |
| Therapeutic Class | Anthracenedione antitumor antibiotic |
| ATC Code | L01BA04 |
| Manufacturing & Regulatory |
| Manufacturer | Roche (originator); Indian suppliers: Ocean Pharma, Saintroy Lifescience, Lexicare, PBP Enterprises |
| Country | India, USA |
| GMP Compliance | ISO, cGMP, WHO-GMP |
| DMF/CEP | Indian generics hold Type II |
| COFEPRIS | Registered (product available for import) |
| Free Sale Certificate | Yes |
| Logistics & Export |
| MOQ | 20 vials |
| Shelf Life | 24 Months |
| Storage | refrigerated at 2–8 °C |
| Incoterms | FOB / CIF / DDP standard |
| Lead Time | 7 to 10 Days |
| Documentation |
| Certificate of Analysis (COA) | Provided by manufacturer/distributor |
| SDS | Cytotoxic infusion handling sheet; MSDS available from manufacturer when requested |
| CTD Summary | CTD dossier available upon request from supplier |
Description
Indications & Usage): Short-form: Approved for acute nonlymphocytic leukemia, metastatic breast cancer, advanced prostate cancer, and secondary progressive multiple sclerosis
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