Nilotinib Capsules Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 150 mg and 200 mg
Reference Brands: Tasigna(US & EU)
Category: Orphan Drugs
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
Frequently Asked Questions
Related Products
Galsulfase Iv
Strength: 1mg/ml
Form: Lyophilized powder for IV
Reference Brands: Vimizim®(US & EU)
View Details
Alglucosidase Alfa Iv
Strength: 50 mg/vial
Form: Lyophilized powder
Reference Brands: Lumizyme®(US & EU)
View Details
Treprostinil Iv Or Sc
Strength: 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL)
Form: SC or Intravenous (IV)
Reference Brands: Remodulin®(US & EU)
View DetailsQuick Response Guaranteed | Verified Suppliers