Ivacaftor API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Kalydeco, Orkambi, Symdeko, Trikafta, Kaftrio

Category: Active Pharmaceutical Ingredient

Ivacaftor is a CFTR potentiator used alone and in combination cystic fibrosis products. It is sourced by formulators, CDMOs and R&D teams preparing future generic filings.

Product Description:

Ivacaftor is a CFTR potentiator: it increases the time the chloride channel stays open at the cell surface, improving salt and water movement in the airways and other organs. It is approved for cystic fibrosis in patients aged 1 month and older (US) who carry at least one CFTR mutation responsive to ivacaftor, and it is also part of fixed-dose combinations with other CFTR modulators (reference brand: Kalydeco, Orkambi, Symdeko, Trikafta, Kaftrio).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 15 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. 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 (2028). European Union: Patent expiry; entry not confirmed (2027).

Handling and quality points

Ivacaftor is practically insoluble in water, which is why finished products rely on a spray-dried amorphous dispersion, so the API's solid form, particle size and residual solvents affect how it processes. The molecule forms several polymorphs and solvates, so agree the form and its XRPD fingerprint with the supplier. It is not a high-potency compound in the usual sense, but standard industrial hygiene and dust control apply.

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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.