Ivacaftor Tablet Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 150 mg
Reference Brands: Kalydeco®(US & EU)
Category:
Orphan Drugs
Ivacaftor tablets enhance cystic fibrosis treatment by acting as a CFTR potentiator, increasing the activity of the defective CFTR protein caused by specific mutations. Benefits include improved lung function, better mucus clearance, and overall quality of life, making it a targeted therapy for eligible cystic fibrosis patients.
Ivacaftor tablet is available in Tablets
and strengths such as 150 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, Ivacaftor tablet 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) |
Ivacaftor tablet 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:
Ivacaftor tablets, marketed as Kalydeco®, are approved for cystic fibrosis treatment in the US and EU. Regulatory agencies like the FDA and EMA reviewed extensive clinical data and manufacturing dossiers for approval, ensuring safety, efficacy, and quality. These dossiers contain detailed information on clinical trials, pharmacology, and manufacturing practices. Kalydeco® is available in 150 mg tablets, offering targeted therapy for specific CF mutations. For expert insights on regulatory processes, dossier submissions, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry analysis.
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