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Suppliers and packagers for generic pharmaceutical drug: patisiran sodium
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patisiran sodium
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922 | NDA | Alnylam Pharmaceuticals, Inc. | 71336-1000-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSE | 2018-08-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Who Supplies Patisiran Sodium? Mapping the Likely Supply Chain for the Drug Product
Patisiran sodium is the active ingredient in Onpattro (patisiran), an RNA interference (RNAi) therapeutic delivered by a lipid nanoparticle (LNP). The supply chain splits into three parts: (1) drug substance manufacturing (patisiran RNA), (2) drug product/LNP manufacturing (formulation and fill-finish), and (3) excipients and lipid supply for the LNP.
Because public filings for specific contract manufacturers and lipid excipient vendors are often consolidated in confidential manufacturing agreements, the only consistently reliable supplier information in public record centers on the marketing authorization holder and manufacturing sites listed in regulatory dossiers. Where those records do not name each upstream supplier, the mapping below focuses on the named entities and functions that determine who “supplies” patisiran sodium as a manufactured product.
Who is the marketing and manufacturing owner for patisiran (Onpattro)?
Patisiran sodium is marketed globally as Onpattro by the Alnylam group:
- Marketing authorization holder (global): Alnylam Pharmaceuticals (brand: Onpattro)
- The product is developed by Alnylam and commercialized under its brand ownership in multiple jurisdictions.
Regulatory product manufacturing records typically list multiple manufacturing sites for:
- drug substance (RNA)
- drug product (LNP formulation, sterile fill, labeling)
Which companies are named for manufacturing steps of Onpattro?
The most actionable “supplier” list for patisiran sodium comes from regulatory product manufacturing site disclosures, which usually identify the responsible manufacturer(s) for drug substance and drug product for each market.
For Onpattro (patisiran), the manufacturing is widely documented in regulatory contexts as involving the following company groups/functions:
- Alnylam-affiliated RNA manufacturing for the drug substance (patisiran RNA)
- LNP formulation and sterile drug product manufacturing at specialized fill-finish sites used by Alnylam and its manufacturing partners
However, public, consistent records that enumerate every upstream vendor that supplies individual lipid components and RNA intermediates are not uniformly disclosed at the level of “supplier” in open sources.
What supply inputs are required to manufacture patisiran sodium (and who supplies them)?
Patisiran sodium (RNAi oligonucleotide) as an LNP drug product requires:
- Synthetic RNA manufacturing inputs
- LNP lipid excipients (ionizable cationic lipid, cholesterol, phospholipid, PEG-lipid)
- Fill-finish materials (buffers, vials, stoppers, sterile filtration components)
The “suppliers” therefore break into:
- RNA supply chain: nucleotide building blocks, solid-phase oligonucleotide synthesis equipment and reagents, purification reagents
- LNP lipid supply chain: ionizable lipid and other LNP lipids from specialized lipid suppliers or internal procurement through contract lipid producers
- Drug product supply chain: sterile manufacturing consumables, primary packaging
In practice, the named manufacturing sites (drug substance and drug product) control procurement, and the lipid suppliers are often tiered and not fully listed publicly.
Supplier mapping by supply-chain layer (practical procurement view)
Drug substance: patisiran (RNA) synthesis and purification
Supplier category: RNA contract manufacturers and internal Alnylam manufacturing.
What matters: reproducible synthesis and purification of the specific patisiran sequence and exact formulation specifications.
Named supplier entities in public record:
- Alnylam Pharmaceuticals / Alnylam manufacturing network (drug substance activity is controlled by the Alnylam development and manufacturing system).
Drug product: LNP formulation and sterile fill-finish
Supplier category: sterile injectable manufacturing and LNP formulation facilities used by Alnylam or its contract manufacturing organizations.
Named supplier entities in public record:
- Alnylam Pharmaceuticals / Alnylam manufacturing network (drug product manufacturing is controlled by the Alnylam network and its contract partners in regulatory dossiers).
Lipid and excipient suppliers for LNP
Supplier category: specialized lipid excipient suppliers (ionizable lipid + cholesterol + helper phospholipid + PEG-lipid) and excipient suppliers.
Public supplier naming constraint:
- LNP lipid vendors are often disclosed only at the ingredient level in regulatory dossiers, and rarely at the vendor-of-record level in open sources.
Actionable supplier list for procurement and partnering decisions
Given the public availability constraints around upstream vendor names, the actionable list for “who supplies patisiran sodium” is:
-
Alnylam Pharmaceuticals
- Controls the development, regulatory ownership, and manufacturing network for Onpattro (patisiran).
-
Manufacturing site(s) listed for Onpattro drug substance and drug product in regulatory product dossiers for each jurisdiction
- These are the entities that actually “supply” the drug substance and finished drug product for market release.
-
Specialized LNP lipid and excipient suppliers supplying ingredient-grade lipids used in the LNP formulation
- These suppliers feed into the drug product manufacturing sites, but are not consistently named as vendor-of-record in open sources.
Key Takeaways
- Alnylam Pharmaceuticals is the controlling owner and the practical supplier interface for patisiran sodium as marketed as Onpattro.
- For high-confidence supplier identification, procurement should map to the drug substance and drug product manufacturing sites listed in regulatory dossiers, because these entities are consistently disclosed and are responsible for product release.
- Upstream LNP lipid and excipient vendors are typically tiered and not consistently disclosed publicly at the vendor-of-record level, so the most reliable “supplier” view remains the named manufacturing entities tied to Onpattro in regulatory filings.
FAQs
1) Is patisiran sodium manufactured by Alnylam or contract partners?
Patisiran (Onpattro) is manufactured under the Alnylam manufacturing system and via its manufacturing network, with site-level responsibilities for drug substance and drug product typically assigned in regulatory filings.
2) Who supplies the final LNP formulated injectable product?
The finished, sterile injectable product is supplied by the drug product manufacturing site(s) listed for Onpattro release in regulatory dossiers.
3) Who supplies the lipid nanoparticles ingredients?
Ionizable lipid, cholesterol, phospholipids, and PEG-lipids are supplied as LNP excipients to the drug product manufacturing sites through specialized lipid supply chains, often not fully vendor-named in public sources.
4) Can a single supplier be identified for “patisiran sodium” globally?
No. The drug is produced through a network: RNA drug substance and LNP drug product steps occur across responsible manufacturing entities for each market’s regulatory release.
5) What is the fastest way to identify the true supplier of record for dosing supply?
Use the jurisdiction-specific regulatory product dossier manufacturing site list for Onpattro to identify the drug substance and drug product manufacturing entities responsible for supply and release.
References
[1] European Medicines Agency. Onpattro (patisiran): EPAR product information and manufacturing-related documents. EMA.
[2] U.S. Food and Drug Administration. Onpattro (patisiran): Label and regulatory review documents for manufacturing information. FDA.
[3] Alnylam Pharmaceuticals. Onpattro (patisiran) prescribing information and corporate product information. Alnylam.
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