Nilotinib 200mg Cap
| Product Overview | |
| Generic Name | Nilotinib 200mg Cap |
| Brand Name(s) | Tasigna |
| Form | 100 Caps, Oral hard gelatin capsules |
| Strength | 200 mg |
| Therapeutic Class | Tyrosine kinase inhibitor (BCR-ABL) for CML |
| ATC Code | L01EA03 |
| Manufacturing & Regulatory | |
| Manufacturer | Novartis |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | Batch-specific |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 100 units |
| Shelf Life | 36 months |
| Storage | 25 °C (15–30 °C) |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Indication & Usage: Chronic Myeloid Leukemia (CML) – Philadelphia Chromosome Positive (Ph+): Newly diagnosed chronic phase Ph+ CML in adult and pediatric patients. Chronic and accelerated phase Ph+ CML in adult patients who are resistant or intolerant to prior therapy, including imatinib. Mechanism of Action: Selectively inhibits the BCR-ABL tyrosine kinase, including several mutant forms resistant to imatinib. Blocks proliferation and induces apoptosis in BCR-ABL–positive cells
