Nilotinib Capsules Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 150 mg and 200 mg
Reference Brands: Tasigna(US & EU)
Category:
Orphan Drugs
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 is available in Capsules
and strengths such as 150 mg and 200 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Nilotinib capsules is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Nilotinib capsules can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
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.
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