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

Suppliers for the Pharmaceutical Drug: Fitusiran Sodium

Last updated: July 30, 2025

Introduction

Fitusiran sodium is an innovative RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals, primarily targeting hemophilia A and B by reducing endogenous antithrombin levels. This mechanism enhances thrombin generation, thereby minimizing bleeding episodes in patients with bleeding disorders. Given its novel mode of action, the supply chain for fitusiran sodium involves specialized manufacturing, regulatory compliance, and distribution channels. Recognizing key suppliers provides crucial insights for stakeholders across pharmaceutical development, manufacturing, and healthcare procurement.

Manufacturers and Raw Material Suppliers

1. Proprietary Development and Manufacturing by Alnylam Pharmaceuticals

Alnylam Pharmaceuticals, based in the United States, is the patent holder and primary manufacturer of fitusiran sodium. Their integrated manufacturing facilities adhere to Good Manufacturing Practices (GMP) to ensure product consistency, purity, and safety. The company's proprietary process involves the synthesis of small interfering RNA (siRNA) molecules, stabilized through GalNAc conjugation to facilitate targeted delivery to hepatocytes.

2. Raw Material Suppliers

The production of fitusiran sodium depends on high-quality raw materials, including nucleotide phosphoramidites, specialized solvents, and conjugation reagents. Major suppliers include:

• DNA and RNA Nucleotide Suppliers: Companies such as Thermo Fisher Scientific, Sigma-Aldrich, and GE Healthcare provide phosphoramidites necessary for synthesizing siRNA sequences.

• Conjugation Reagents: Specialty chemicals like N-acetylgalactosamine (GalNAc) conjugates are supplied by chemical manufacturers experienced in bio-conjugation, including:

  • Bionova Scientific and TriLink Biotechnologies, known for their custom conjugation reagents tailored for nucleic acid therapeutics.

• Lipids and Delivery Vehicles: For the formulation process, lipids used in nanoparticle formulations come from suppliers like Lipoid GmbH or Avanti Polar Lipids.

3. Formulation and Packaging Components

The final drug product requires excipients, vials, and syringes from providers such as West Pharmaceutical Services and Schott AG. These suppliers ensure the integrity and stability of the injectable formulation.

Supply Chain Partners and Contract Manufacturers

4. Contract Manufacturing Organizations (CMOs)

Alnylam collaborates with CMOs for scaling production, particularly during commercial launches and clinical trial phases:

• Bionova Scientific: Specializes in the manufacturing of complex oligonucleotides and conjugates, supporting scale-up for clinical and commercial needs.

• Recipharm: Known for biologics and oligonucleotide manufacturing, offering GMP-grade production.

5. Distribution and Logistics

Distribution channels must comply with cold chain logistics, especially for injectable RNAi therapeutics:

• Pharmaceutical Distribution Companies: Companies such as McKesson and Cardinal Health manage global distribution, ensuring cold chain integrity.

• Specialized Biopharma Logistics: Firms like World Courier and DHL adequately handle temperature-sensitive biologics, facilitating global reach.

Regulatory and Quality Compliance

Suppliers must comply with stringent regulatory standards:

• FDA and EMA Regulations: Raw materials and manufactured fitusiran sodium must comply with GMP requirements under FDA and EMA guidelines, ensuring safety and efficacy.

• Certificate of Analysis (CoA): Suppliers routinely provide CoA to verify raw material quality, critical in sourcing high-purity nucleic acids and conjugates.

Emerging and Alternative Suppliers

While Alnylam currently maintains control over manufacturing, the evolving landscape of RNAi therapeutics encourages diversification:

• Innovative Nucleic Acid Suppliers: Companies like Integrated DNA Technologies (IDT) or Twist Bioscience are rapidly expanding their GMP offerings for custom nucleic acid synthesis.

• Synthetic Biology Firms: Startups developing novel conjugation chemistries and delivery platforms could serve as future alternative suppliers.

Challenges and Considerations in the Supply Chain

Ensuring uninterrupted supply of fitusiran sodium involves navigating complexities:

• Manufacturing Constraints: Viral or process bottlenecks at Alnylam or CMOs could impact availability.

• Raw Material Scarcity: Niche reagents like GalNAc conjugates are in high demand and subject to supply constraints.

• Intellectual Property Restrictions: Patents protect the synthesis and conjugation processes, potentially limiting alternative sourcing.

• Regulatory Approvals: Changes in suppliers require validation and regulatory approval, delaying availability.

Conclusion

The supply of fitusiran sodium depends on precise coordination among Alnylam Pharmaceuticals, raw material suppliers specializing in nucleic acids and conjugates, CMOs for scale-up, and logistics providers capable of maintaining cold chain integrity. While Alnylam maintains full control over the core manufacturing process, a broad ecosystem of suppliers supports the production lifecycle, ensuring the availability of this transformative therapy.

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Key Takeaways

• Primary Manufacturer: Alnylam Pharmaceuticals remains the central provider of fitusiran sodium, leveraging proprietary manufacturing processes.

• Raw Material Suppliers: Specialized in nucleotide phosphoramidites, GalNAc conjugates, and delivery lipids; key players include Thermo Fisher Scientific, Sigma-Aldrich, and TriLink Biotechnologies.

• Contract Manufacturing: Collaborations with CMOs such as Bionova Scientific and Recipharm enable scale-up and commercialization.

• Distribution: Cold chain logistics and specialized pharma logistics firms ensure global delivery of this thermo-sensitive biologic.

• Supply Chain Challenges: Manufacturing bottlenecks, raw material shortages, and regulatory hurdles necessitate strategic planning for stakeholders.

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FAQs

1. Who are the main suppliers of raw materials used in the synthesis of fitusiran sodium?
Major suppliers include Thermo Fisher Scientific, Sigma-Aldrich, and TriLink Biotechnologies, which provide nucleotide phosphoramidites and conjugation reagents critical for siRNA synthesis and GalNAc conjugation.

2. Does Alnylam Pharmaceuticals outsource manufacturing of fitusiran sodium?
Yes, while Alnylam develops and controls core manufacturing, it partners with CMOs like Bionova Scientific and Recipharm to scale production, especially for clinical and commercial supplies.

3. What logistical considerations are critical for the distribution of fitusiran sodium?
Because it is a thermally sensitive biologic, cold chain logistics managed by logistics providers such as DHL and World Courier are essential to maintain drug stability across global markets.

4. Are there alternative suppliers for the key components of fitusiran sodium?
Potentially, emerging nucleic acid synthesis companies like Twist Bioscience and IDT could serve as future sources, but current reliance remains primarily on established suppliers due to regulatory and quality standards.

5. What regulatory challenges exist in diversifying the supply chain for fitusiran sodium?
Any change in suppliers or raw materials requires regulatory validation and approval, which can delay manufacturing and distribution, emphasizing the importance of validated, GMP-compliant supply sources.