Product/Composition:- | Nilotinib capsules |
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Strength:- | 150 mg and 200 mg |
Form:- | Capsules |
Reference Brands:- | Tasigna(US & EU) |
MOQ | As per the manufacturer batch size |
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Nilotinib is a tyrosine kinase inhibitor that blocks BCR-ABL fusion protein activity in chronic myeloid leukemia (CML). It reduces abnormal cell proliferation, induces apoptosis, and improves long-term survival. Benefits include effective disease control, decreased progression risk, and improved quality of life for CML patients.
Nilotinib capsules, marketed as Tasigna, are approved in the US by the FDA and in the EU via EMA for treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. The FDA reviews clinical trial and manufacturing data for timely approval, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports swift approval, safe use, and worldwide availability, enabling effective long-term disease management for CML patients across regions.