Nilotinib Capsules 150 mg and 200 mg 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.
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.
Nilotinib Capsules — third party manufacturing & bulk supply
Nilotinib Capsules 150 mg and 200 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Nilotinib Capsules listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Nilotinib Capsules →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Nilotinib is used for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults and pediatric patients. It is prescribed for newly diagnosed patients as well as for those who are resistant or intolerant to prior therapies such as imatinib. It works by blocking abnormal BCR-ABL tyrosine kinase activity that drives leukemia cell growth.
Nilotinib is made from the active pharmaceutical ingredient nilotinib hydrochloride monohydrate, which is a targeted tyrosine kinase inhibitor designed to specifically inhibit BCR-ABL signaling in leukemia cells.
The main trade name of nilotinib is Tasigna.
The original brand Tasigna is developed and marketed by Novartis. Generic versions may also be manufactured by other approved pharmaceutical companies in some markets.
The generic name is nilotinib hydrochloride monohydrate.
The brand name is Tasigna.
Nilotinib is manufactured in regulated pharmaceutical facilities across the USA, EU, UK, and other countries depending on the manufacturer and marketing authorization holder.
Related Products
Pasireotide Diaspartate
Strength:
0.3 mg/mL, 0.6 mg/mL, 1.2 mg/mL, 10 mg, 20 mg, 30 mg
Form: Injection
Reference Brands: Signifor (USA/EU)
View Details
Sepiapterin
Strength:
1000 mg, 250 mg
Form: Tablets / oral powder
Reference Brands: Sephience (USA/EU)
View Details
Glycerol Phenylbutyrate
Strength:
1.1 g/mL
Form: Oral Solution
Reference Brands: Ravicti (USA)
View DetailsQuick Response Guaranteed | Verified Suppliers
