Busulfan 60 mg /10mL
| Product Overview | |
| Generic Name | Busulfan 60 mg /10mL |
| Brand Name(s) | Busulfex®, Busilvex® |
| Form | Sterile IV injection / concentrate for solution for infusion |
| Strength | 60 mg / 10 mL (6mg/mL) |
| Therapeutic Class | Alkylating antineoplastic agent; alkyl sulfonate; bifunctional alkylating agent |
| ATC Code | L01AB01 |
| Manufacturing & Regulatory | |
| Manufacturer | Otsuka, Celon, Fresenius-Kabi |
| Country | EU, Mexico, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II DMF / LOA |
| COFEPRIS | 010.000.6307.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 8 vials |
| Shelf Life | 24 months at 2–8°C |
| Storage | Refrigerated 2°C–8°C; do not freeze |
| Incoterms | EXW, HS/HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Request a GHS-compliant SDS/MSDS |
| CTD Summary | Not publicly available as a full CTD. |
Description
Clave 010.000.6307.00. Public-sector wording: BUSULFÁN, solución inyectable; cada mL contiene busulfán 6.0 mg; envase con 8 frascos ámpula o vial de 60 mg/10 mL. Busulfán 60 mg/10 mL is an intravenous cytotoxic alkylating agent used primarily as part of myeloablative conditioning regimens before haematopoietic stem-cell transplantation, commonly in combination with cyclophosphamide or other conditioning agents. It requires specialist hospital administration, therapeutic monitoring where applicable, seizure prophylaxis according to institutional protocol, and close monitoring for profound myelosuppression, infection, hepatic veno-occlusive disease/sinusoidal obstruction syndrome, pulmonary toxicity, mucositis, infertility, and embryo-foetal toxicity
