Ivabradine Hydrochloride API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Corlanor, Procoralan

Category: Active Pharmaceutical Ingredient

Ivabradine hydrochloride is an If-channel blocker that slows the heart rate, used in heart failure and stable angina. Formulators, CDMOs and R&D teams source the API.

Product Description:

Ivabradine selectively blocks the If ('funny') current in the heart's sinus node, which slows the heart rate without lowering blood pressure or the force of contraction. It is approved for stable symptomatic chronic heart failure with reduced ejection fraction in adults and for paediatric heart failure due to dilated cardiomyopathy, as defined in the US label; in the EU it is also approved for symptomatic chronic stable angina (reference brand: Corlanor, Procoralan).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 10 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: Generics/biosimilars on the market (Aug 2024). European Union: No confirmed date.

Handling and quality points

Ivabradine hydrochloride shows marked polymorphism, with seven crystalline forms reported in one EU assessment, and several forms are patent-protected, so the form must be fixed in the specification and confirmed by XRPD. It is a single (S)-enantiomer, with the (R)-isomer controlled as an impurity. Regulators expect an ICH M7 assessment of potentially mutagenic impurities and a nitrosamine risk assessment, as the molecule contains a tertiary amine.

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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.