Lumacaftor API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Orkambi

Category: Active Pharmaceutical Ingredient

Lumacaftor is a CFTR corrector used with ivacaftor in a fixed-dose combination for cystic fibrosis. It is sourced by formulators, CDMOs and R&D teams developing combination products.

Product Description:

Lumacaftor is a CFTR corrector: it helps the faulty F508del-CFTR protein fold properly and reach the cell surface, where ivacaftor then improves how the channel opens. The combination is approved for people with cystic fibrosis aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene (reference brand: Orkambi).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 1 active Type II API DMF for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (2031). European Union: Patent expiry; entry not confirmed (2030).

Handling and quality points

Lumacaftor is practically insoluble in water, so the formulator will want tight control of crystal form and particle size, confirmed by XRPD and laser diffraction. Because it is combined with ivacaftor in one tablet, check that impurity limits and analytical methods work for a fixed-dose product and that the two APIs are compatible in the blend. Standard requests include residual solvents, elemental impurities and a nitrosamine risk assessment.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.