Suppliers and packagers for generic pharmaceutical drug: FITUSIRAN SODIUM

FITUSIRAN 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
Genzyme Corp	QFITLIA	fitusiran sodium	SOLUTION;SUBCUTANEOUS	219019	NDA	Genzyme Corporation	58468-0347-1	1 VIAL in 1 CARTON (58468-0347-1) / .2 mL in 1 VIAL	2025-03-28
Genzyme Corp	QFITLIA	fitusiran sodium	SOLUTION;SUBCUTANEOUS	219019	NDA	Genzyme Corporation	58468-0348-1	1 SYRINGE in 1 CARTON (58468-0348-1) / .5 mL in 1 SYRINGE	2025-03-28

Fitusiran Sodium Suppliers: Manufacturing Sources, Raw Materials, and Contract Supply Landscape

Last updated: May 28, 2026

Executive summary Fitusiran sodium supply chain is dominated by (1) upstream procurement of oligonucleotide synthesis inputs and conjugation-capable CMO capacity for triantennary N-acetylgalactosamine (GalNAc)–targeted siRNA, (2) sterile drug product filling/finishing capable of handling oligonucleotide formulations, and (3) quality-system–driven release testing suppliers. Public, name-level supplier lists for fitusiran sodium are not consistently disclosed in FDA documents or in public contracting databases; suppliers are therefore identified at the company-function level through manufacturing, filling, and testing roles tied to the product’s regulatory submissions and related filings.

Which companies supply fitusiran sodium as a finished drug product?

Answer: Fitusiran sodium’s finished-dose supply is produced through a limited set of GMP manufacturers and CMO networks with oligonucleotide and GalNAc-siRNA competence, plus sterile filling/packaging and release testing partners. Name-level supplier attribution is typically limited to manufacturer-of-record and testing facilities in FDA chemistry and manufacturing information, plus those disclosed in the product’s labeling and related submission documents.

Manufacturing-of-record vs. functional suppliers

In practice, “suppliers” for a GalNAc-targeted siRNA like fitusiran sodium split into four buckets:

1. Drug substance (DS) manufacturer: oligonucleotide synthesis, conjugation, purification, characterization.
2. Drug product (DP) manufacturer: formulation, sterile manufacturing controls, aseptic processing.
3. Fill-finish partner: vial filling, stoppering, capping, labeling, packaging.
4. Analytical/release testing: identity, purity, potency/functional activity assays, oligonucleotide impurities, endotoxin/sterility, stability.

Public disclosures usually identify the DP manufacturer-of-record and sometimes contract partners, but rarely publish the full “Bill of Materials” supplier list for key raw inputs (bases, phosphoramidites, conjugation reagents) or every analytical reagent provider.

What raw-material and intermediate suppliers are required for fitusiran sodium synthesis?

Answer: The fitusiran sodium upstream supplier base is concentrated around oligomer synthesis consumables, conjugation reagents, and controlled oligonucleotide building blocks.

Core upstream inputs for GalNAc-siRNA

For GalNAc-conjugated siRNA, DS supply typically depends on:

• Oligonucleotide synthesis consumables (commonly including protected nucleosides, phosphoramidites, activators, capping reagents, oxidizers, solvents).
• Linker/conjugation chemistry inputs for the GalNAc ligand installation and siRNA conjugation.
• Purification and characterization inputs such as chromatographic resins, standards, and reference materials.
• Lipid-free formulation excipient suppliers if used in DP (the specific excipient set is formulation-dependent and is controlled through the CMC package).

“Supplier” reality for siRNA: fewer name-level disclosures

For siRNA drugs, the sponsor-and-CMO ecosystem controls raw material sourcing under quality agreements and change-management to maintain lot-to-lot consistency. Public materials often do not expose the named chemical vendors beyond what is embedded in CMC appendices or referred to in trade press or procurement reports.

Which CMOs have the capability to manufacture GalNAc-targeted siRNA like fitusiran sodium?

Answer: Capability is defined by siRNA DS synthesis and GalNAc conjugation plus sterile DP operations. The supplier set is CMO networks with proven oligonucleotide/GalNAc-siRNA track records rather than general-purpose chemical suppliers.

Capability map that a fitusiran sodium CMO must support

A fitusiran sodium–grade CMO typically must have:

• GMP oligonucleotide DS synthesis with validated impurity control.
• GalNAc ligand conjugation and purification processes.
• DP formulation controls for oligonucleotides (handling to prevent adsorption, degradation, and aggregation).
• Aseptic manufacturing, sterilization strategy (if applicable), and vial-based fill-finish.
• Analytical labs with validated potency assays and impurity panels for siRNA.

What does FDA labeling or regulatory documentation show about fitusiran sodium manufacturing?

Answer: FDA product labeling identifies manufacturer-of-record and/or sponsor contact, while full supplier-of-record details are usually embedded in the CMC section of the NDA/BLA submissions and not presented as public supplier lists.

Orange Book listings: why they don’t resolve “suppliers”

Even when a product appears in FDA’s publication channels, supplier identity is not reliably enumerated. Orange Book listings focus on exclusivity and patent coverage, not the full procurement tree.

How do contract supply and licensing deals affect fitusiran sodium supplier availability?

Answer: For targeted oligonucleotide therapeutics, sponsor-controlled CMC strategy and vendor qualification requirements often govern supply continuity more than patent restrictions.

Typical supply constraints in GalNAc-siRNA

• Multi-step DS and conjugation processes with narrow process windows.
• Tight QMS change controls for raw materials and analytical reference standards.
• Analytical comparability requirements across sites or requalified lots.
• Regulatory alignment for new sites, transfer packages, and stability updates.

What are the main “supplier risk” points for fitusiran sodium launches and re-supply?

Answer: The biggest supply risks are process- and qualification-heavy steps, not commodity chemical inputs.

High-risk nodes in the supply chain

1. DS synthesis and purification: impurity profile sensitivity and reference standard dependencies.
2. GalNAc conjugation: reaction reproducibility and purification yields.
3. Analytical testing: validated potency and impurity panels and reference material sourcing.
4. Sterile fill-finish: aseptic control and container-closure integrity qualification.

Comparative: how fitusiran sodium’s supplier model compares to other GalNAc-siRNA drugs

Answer: The supplier pattern tracks the GalNAc-siRNA class: a small set of specialized oligonucleotide CMOs plus sterile fill-finish networks and analytical labs.

Class-level pattern (directional)

• Sponsors often use one DS CMO and one DP/fill-finish partner, with additional analytic testing capacity under GMP.
• Site transfers and new vendors require full comparability packages, driving lead times.

Key Takeaways

• “Suppliers for fitusiran sodium” are best understood as GMP DS and DP/fill-finish CMOs plus GMP analytical release partners, not a broad open vendor list.
• The critical supplier constraints for GalNAc-siRNA are DS synthesis, GalNAc conjugation, validated potency/impurity testing, and sterile fill-finish qualification.
• Public sources generally do not provide a comprehensive named list of upstream chemical and intermediate vendors for fitusiran sodium, so procurement due diligence must focus on qualified GMP partners and documented regulatory roles (manufacturer-of-record and testing facilities) rather than commodity supplier directories.

FAQs

1. What differentiates DS and DP suppliers for fitusiran sodium?
   DS suppliers execute siRNA synthesis and GalNAc conjugation under impurity-controlled GMP; DP suppliers formulate and aseptically manufacture the filled dosage form.

2. Can a generic manufacturer buy “fitusiran sodium raw materials” from commodity chemical suppliers?
   The functional constraint is not only raw availability but GMP-qualified, specification-controlled inputs tied to validated DS and analytical reference standards.

3. What analytical testing suppliers are required for fitusiran sodium release?
   Release requires identity, purity/impurity panels, potency/functional activity assays, and sterility/endotoxin testing in GMP labs with validated methods.

4. How long does it take to qualify a new manufacturer for a GalNAc-siRNA like fitusiran sodium?
   Vendor onboarding typically requires GMP readiness, comparability runs, analytical cross-validation, stability updates, and regulatory alignment, which materially extends timelines.

5. What’s the most common supply-chain bottleneck for fitusiran sodium?
   DS synthesis/conjugation steps and validated analytical testing capacity are the typical bottlenecks due to process sensitivity and qualification load.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.gov.
2. FDA. Labeling and Drug Approval Package information for fitusiran sodium (as available through FDA access channels). FDA.gov.