Nilotinib 50mg Cap
| Product Overview |
| Generic Name | Nilotinib 50mg Cap |
| Brand Name(s) | Tasigna |
| Form | Hard gelatin capsules |
| Strength | 50 mg |
| Therapeutic Class | BCR‑ABL1 tyrosine‑kinase inhibitor |
| ATC Code | L01XE08 |
| Manufacturing & Regulatory |
| Manufacturer | Novartis, Cipla, Danziten |
| Country | India/USA/EU |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Type II DMFs |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export |
| MOQ | 10 units |
| Shelf Life | 36 months |
| Storage | Store at controlled room temperature (20–25 °C) |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indications & Usage: Nilotinib 50 mg capsules are indicated for:
• Adult and pediatric (≥ 1 yr) patients with Ph+ chronic myeloid leukemia (CML) in chronic phase newly diagnosed;
• Adult patients with Ph+ CML chronic or accelerated phase resistant or intolerant to prior imatinib therapy
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