Lumacaftor + Ivacaftor Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 200 mg lumacaftor + 125 mg ivacaftor
Reference Brands: Orkambi®(US & EU)
Category: Orphan Drugs
Lumacaftor + Ivacaftor tablets treat cystic fibrosis by combining a CFTR corrector (lumacaftor) that improves protein folding and trafficking with a potentiator (ivacaftor) that enhances CFTR channel activity. Benefits include increased lung function, reduced symptoms, improved quality of life, and decreased hospitalization rates in eligible CF patients.
Product Description: Lumacaftor + Ivacaftor tablets, marketed as Orkambi®, are approved by the FDA and EMA for cystic fibrosis treatment. Regulatory dossiers include comprehensive clinical trial data, manufacturing details, and safety profiles, supporting approval and market access. These dossiers demonstrate the therapy's efficacy in improving lung function and reducing CF symptoms. Orkambi® is available as a fixed-dose combination tablet, with 200 mg lumacaftor and 125 mg ivacaftor. For detailed insights on regulatory processes, dossier submissions, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry analysis.
Lumacaftor + Ivacaftor Tablets — third party manufacturing & bulk supply
Lumacaftor + Ivacaftor Tablets 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 Lumacaftor + Ivacaftor Tablets 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 Lumacaftor + Ivacaftor Tablets →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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