Azacitidine 100mg
| Product Overview | |
| Generic Name | Azacitidine 100mg |
| Brand Name(s) | Vidaza, Onureg, Azadine, Xpreza |
| Form | Powder for suspension/injection (reconstituted) |
| Strength | 100mg per vial |
| Therapeutic Class | Pyrimidine analogue / nucleoside metabolic inhibitor (antimetabolite). |
| ATC Code | L01BC07 |
| Manufacturing & Regulatory | |
| Manufacturer | INTAS, CIPLA, |
| Country | Ireland, Mexico, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not a single DMF number |
| COFEPRIS | 010.000.5887.00 |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 24 Months |
| Storage | Unreconstituted vials: typically controlled room temperature storage is permitted |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | CTD proprietary; available under commercial agreement/license |
Description
Azacitidine is an antineoplastic hypomethylating agent (pyrimidine analogue) used primarily in myelodysplastic syndromes (MDS) and related myeloid disorder