Patisiran Sodium API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Onpattro
Category: Active Pharmaceutical Ingredient
Patisiran sodium is an siRNA duplex delivered in lipid nanoparticles to treat hATTR amyloidosis polyneuropathy. It is sourced by oligonucleotide CDMOs, formulators and research teams.
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Product Description:
Patisiran is a double-stranded small interfering RNA that binds a conserved sequence in the 3' untranslated region of transthyretin (TTR) messenger RNA, so the liver makes less of both the mutant and normal TTR protein that forms amyloid deposits. It is given inside lipid nanoparticles that carry it to liver cells. It is approved for the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults (reference brand: Onpattro).
Specification at a glance
| Traded form | Sodium salt of a partly 2'-O-methyl-modified siRNA duplex; free acid CAS 1420706-45-1 (C412H520N148O290P40, about 13,424 g/mol). The finished product is a lipid nanoparticle dispersion. |
|---|---|
| CAS number | 1386913-72-9 |
| Molecular formula | C412H480N148Na40O290P40 |
| Molecular weight | 14,304 Da (sodium salt) |
| Pharmacopoeia | No pharmacopoeia monograph found; supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 0 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 2032 (compound patent)). European Union: No confirmed date.
Handling and quality points
The drug substance is the siRNA sodium salt; the lipid nanoparticle is made at the finished-product stage, so the lipids (including the ionisable lipid and the PEG-lipid) are a separate sourcing question. For the siRNA itself, check sequence confirmation, duplex purity, related oligonucleotide impurities, sodium and water content, and endotoxin limits. The finished product is stored at 2 to 8 °C, so settle drug substance storage and cold-chain shipping against the supplier's 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.
Patisiran Sodium API — third party manufacturing & bulk supply
Patisiran Sodium API is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
Indicative minimum order quantity
Patisiran Sodium API is supplied as API (drug substance) — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.
Manufacturers of Patisiran Sodium API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Patisiran Sodium API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Buyers usually start with a GMP certificate, the specification and a recent certificate of analysis showing identity by mass and sequence, duplex purity and impurity levels. Ask about US DMF or EU ASMF status and letters of access, and request stability data, a residual solvent statement and a nitrosamine risk assessment.
Usually not. The API is the siRNA duplex as a sodium salt, and encapsulation in lipid nanoparticles is a separate, specialised step carried out during drug product manufacture. If you need formulated material, look for a CDMO with lipid nanoparticle experience and confirm which lipids it can supply.
Yes. We introduce licensed manufacturers, CDMOs and R&D teams to GMP-compliant oligonucleotide makers once their documents have been checked. Your enquiry stays confidential until both sides agree to share details.
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