Ribociclib Succinate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Kisqali

Category: Active Pharmaceutical Ingredient

Ribociclib succinate is the CDK4/6 inhibitor salt used in hormone receptor-positive breast cancer. It is sourced by formulation makers, CDMOs and research teams.

Product Description:

Ribociclib is a selective inhibitor of cyclin-dependent kinases 4 and 6, which stops cancer cells moving through the cell cycle. It is approved for HR-positive, HER2-negative advanced or metastatic breast cancer with an aromatase inhibitor or fulvestrant, and with an aromatase inhibitor as adjuvant treatment of stage II and III early breast cancer at high risk of recurrence (reference brand: Kisqali).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 9 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 (Jun 2028-Nov 2031). European Union: No confirmed date.

Handling and quality points

Ribociclib is normally handled as a potent compound with containment during weighing and blending. The molecule carries a piperazine NH, so buyers routinely ask for a nitrosamine risk assessment that covers the N-nitroso derivative of the drug. Salt stoichiometry, the crystalline form of the succinate and colour (the label describes a light yellow to yellowish brown powder) are sensible items for the specification.

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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.