Lumacaftor + Ivacaftor tablets bulk supplier for pharma manufacturers

Lumacaftor + Ivacaftor Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 200 mg lumacaftor + 125 mg ivacaftor

Reference Brands: Orkambi®(US & EU)

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.

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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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Lumacaftor + Ivacaftor Tablets is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and 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.

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Frequently Asked Questions

Lumacaftor + Ivacaftor tablets is listed as Tablets in 200 mg lumacaftor + 125 mg ivacaftor. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Lumacaftor + Ivacaftor tablets is referenced against Orkambi®(US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.