Inclisiran Sodium API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Leqvio

Category: Active Pharmaceutical Ingredient

Inclisiran sodium is a GalNAc-conjugated small interfering RNA that lowers LDL cholesterol. It is sourced by injectable developers, CDMOs and R&D teams working on oligonucleotide medicines.

Product Description:

Inclisiran is a double-stranded small interfering RNA (siRNA) linked to a triantennary N-acetylgalactosamine (GalNAc) ligand, which carries it into liver cells, where it silences the messenger RNA for PCSK9 so the liver clears more LDL cholesterol from the blood. In the US it is approved as an adjunct to diet and exercise to lower LDL-C in adults with hypercholesterolaemia and in patients aged 12 and over with heterozygous or homozygous familial hypercholesterolaemia (reference brand: Leqvio). It is also authorised in the EU for primary hypercholesterolaemia and mixed dyslipidaemia.

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 3 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 (Dec 2029-Aug 2034). European Union: Patent expiry; entry not confirmed (Dec 2030 (regulatory protection, est.)).

Handling and quality points

Inclisiran is built by solid-phase synthesis of two modified strands that are then annealed, so the questions that matter are how the supplier confirms sequence identity and controls duplex purity, shorter and longer failure sequences, phosphorothioate content and residual solvents. Ask how the GalNAc ligand is attached and characterised, how sodium counter-ion and water content are reported, and what endotoxin and bioburden limits apply, as the material goes into a sterile injectable. Oligonucleotide powders pick up moisture readily, so agree packaging and the storage and shipping temperature against the supplier's own stability data.

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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.