Hydroxyurea 500 mg (Hydroxycarbamide)
| Product Overview | |
| Generic Name | Hydroxyurea 500 mg (Hydroxycarbamide) |
| Brand Name(s) | Hydrea, Droxia, Siklos, Xromi, Tharolax, Hondrea, Oxyrea, Cytodrox, Myelostat, |
| Form | Oral capsule/tablet |
| Strength | 500 mg capsules/tablets |
| Therapeutic Class | Cytoreductive agent; ribonucleotide reductase inhibitor |
| ATC Code | L01XX05 |
| Manufacturing & Regulatory | |
| Manufacturer | Novartis (Hydrea, USA); Taj Pharma, Cipla, Intas, Alkem, Zydus, United Biotech |
| Country | India |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Type II |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | Pack of 25 |
| Shelf Life | 36 months |
| Storage | 20–25 °C, protect from light; do not freeze |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon supply |
| SDS | Upon Request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Indications & Usage: Sickle cell anemia (reduce crises/transfusions), CML, polycythemia vera, essential thrombocythemia, cervical cancer, psoriasis, HIV adjunct
