Ixazomib Citrate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Ninlaro

Category: Active Pharmaceutical Ingredient

Ixazomib citrate is the oral proteasome inhibitor used in multiple myeloma. Formulation makers, CDMOs and R&D teams source it for generic capsule development.

Product Description:

Ixazomib is a reversible proteasome inhibitor. It is supplied as ixazomib citrate, a boronic ester prodrug that hydrolyses in the body to the active boronic acid. It is approved, in combination with lenalidomide and dexamethasone, for adults with multiple myeloma who have received at least one prior therapy (reference brand: Ninlaro).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 7 active Type II API DMFs 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 (Aug 2027). European Union: No confirmed date.

Handling and quality points

Treat ixazomib citrate as a potent cytotoxic: weighing and charging belong in contained equipment, and most buyers ask for the maker's exposure band and cleaning validation for any shared line. The citrate ester converts to the free boronic acid in water, so moisture control during packing and storage matters, and the specification should cover stereochemical purity and boronic acid-related impurities. A nitrosamine risk assessment is now expected for any synthetic API filed in the EU or US.

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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.