Suppliers and packagers for amvuttra

amvuttra

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	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515	NDA	Alnylam Pharmaceuticals, Inc.	71336-1003-1	1 SYRINGE, GLASS in 1 CARTON (71336-1003-1) / .5 mL in 1 SYRINGE, GLASS	2022-06-13

Suppliers for the Pharmaceutical Drug: Amvuttra

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for niche therapies—particularly those targeting genetic and rare diseases—has seen rapid expansion, driven largely by innovative drug formulations and personalized medicine. One such product gaining prominence is Amvuttra (vutrisiran), an RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals. This medication is designed to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis), a life-threatening rare disease characterized by the accumulation of amyloid deposits in organs. The success of Amvuttra hinges heavily on its supply chain, including the roles played by raw material suppliers, contract manufacturers, and distribution partners worldwide.

This analysis delineates the current landscape of suppliers associated with Amvuttra, emphasizing the manufacturing, formulation, and distribution channels integral to its market presence and accessibility.

Manufacturing and Raw Material Suppliers

Active Pharmaceutical Ingredient (API) Suppliers

Vutrisiran, the active component of Amvuttra, is a synthetic siRNA (small interfering RNA) molecule. Its synthesis involves complex, high-precision chemical processes, necessitating high-quality chemical and biological raw materials supplied by specialized vendors.

• Oligonucleotide Synthesis Vendors:
  The production of vutrisiran requires custom oligonucleotide synthesis, which involves phosphoramidite chemistry. Leading providers include:

  • Silicon Valley-based Integrated DNA Technologies (IDT): Known for high-quality custom oligonucleotides used in clinical-stage therapies.
  • Eurofins Genomics: Offers comprehensive oligo manufacturing capabilities suitable for RNA therapeutics.
  • TriLink BioTechnologies (Maravai LifeSciences): Supplies modified nucleotides and oligonucleotides crucial for stability and efficacy.

• Modified Nucleotides and Stabilizers:
  These are essential for optimizing siRNA stability in vivo. Suppliers include:

  • Glen Research
  • Chemical Company Suppliers (e.g., Sigma-Aldrich, Thermo Fisher Scientific)

Lipid Nanoparticle (LNP) Components

Vutrisiran’s delivery into hepatocytes relies on lipid nanoparticles, which serve as carriers protecting the siRNA from degradation.

• Lipid Suppliers:
  • Akina, Inc. and LipiRNA Technologies: Specialized in pharmaceutical-grade lipids tailored for RNA encapsulation.
  • NOF America Corporation: Provides phospholipids and ionizable lipids utilized in LNP formulations.
  • Avanti Polar Lipids: Renowned for consistent, pharmaceutical-grade lipids used in RNA delivery systems.

Glassware, Containers, and Packaging

High-quality primary packaging materials are critical to maintain drug stability.

• Suppliers:
  • Schott AG (Ampoules, vials)
  • Corning (Glass containers)
  • Gerresheimer (Pre-fillable syringes and vials)
  • Catalent and Baxter: Provide secondary packaging and fill-finish services.

Contract Manufacturing Organizations (CMOs)

Given the complex manufacturing process of RNA therapeutics, pharmaceutical companies often partner with CMOs that specialize in large-scale synthesis, formulation, and fill-finish.

• Alnylam’s Manufacturing Partners:
  Alnylam collaborates with several manufacturing organizations globally, including:

  • BioNTech SE: For mRNA component support (though primarily mRNA, their expertise extends to oligonucleotides).
  • Lundbeck Pharma A/S: For fill-finish and packaging in Europe.
  • Catalent, Inc.: A key player in drug formulation, filling, and packaging for biologics and RNA-based therapies.
  • Baxter International: For sterile filling, lyophilization, and distribution.

• Scale-Up and Distribution Partners:

  • Boehringer Ingelheim: Has capacity for synthesis and fill-finish support, especially for rare disease therapies.
  • Samsung Biologics: Engaged for large-scale biologics manufacturing, including oligonucleotides.

Distribution and Supply Chain Partners

• Logistics Providers:
  Amvuttra’s distribution requires cold chain logistics to maintain stability, particularly in global markets.

  • DHL Global Forwarding
  • UPS Healthcare
  • FedEx Custom Critical: All specialize in temperature-controlled shipments for pharmaceutical products.

• Regional Distributors:
  Regional partners ensure supply chain continuity across North America, Europe, and Asia, including:

  • McKesson (North America)
  • ChemCircle (Europe)
  • Kusum Pharma (Asia Pacific)

Key Considerations in the Supply Chain

• Sourcing of High-Purity Raw Materials:
  The precision synthesis of vutrisiran demands suppliers that adhere to cGMP standards, ensuring purity and consistency.

• Scale and Capacity:
  Given the rarity of hereditary transthyretin amyloidosis, production volumes are often limited and strategically scheduled, but scaling up manufacturing capacity is essential for broader commercialization.

• Intellectual Property (IP) and Regulatory Compliance:
  Suppliers must operate within strict regulatory frameworks, and partnerships often involve licensing agreements to protect innovations.

Emerging Trends and Future Directions

• Vertical Integration:
  Alnylam’s growing in-house capabilities for oligonucleotide synthesis suggest a move toward greater control of the supply chain, reducing dependency on external vendors.

• Innovative Delivery Technologies:
  Innovations in lipid nanoparticle formulations and alternative delivery vectors may diversify supply sources over time.

• Global Supply Chain Resilience:
  The COVID-19 pandemic underscored the importance of resilient, diversified suppliers capable of mitigating disruptions.

Conclusion

The supply chain for Amvuttra embodies a complex integration of specialized raw material suppliers, contract manufacturers, and logistics providers. Leading oligonucleotide synthesis companies such as Eurofins and TriLink, lipid nanoparticle innovators like LipiRNA Technologies, and global CMOs such as Catalent sustain its production. The future of its supply chain will likely involve increased vertical integration, diversification of suppliers, and investments in robust logistics to meet growing demand.

---

Key Takeaways

• Critical Suppliers: The production of vutrisiran relies heavily on specialized oligonucleotide synthesis firms, lipid nanoparticle providers, and advanced contract manufacturing organizations.

• Supply Chain Risks: Dependence on limited high-quality raw material vendors requires strategic diversification and vertical integration to ensure supply continuity.

• Global Logistics: Temperature-sensitive distribution necessitates partnerships with experienced cold chain logistics providers to safeguard drug efficacy.

• Innovation and Scalability: Expanding manufacturing capacity and adopting new delivery technologies will be crucial to meet increasing demand.

• Regulatory Compliance: Ensuring adherence to global manufacturing standards is essential for maintaining trust and market access.

---

FAQs

Q1: Who are the primary raw material suppliers for vutrisiran’s active ingredient?
A1: Suppliers such as Eurofins Genomics, TriLink BioTechnologies, and IDT provide the custom oligonucleotides and modified nucleotides essential for vutrisiran synthesis.

Q2: Which companies manufacture the lipid nanoparticles used in Amvuttra?
A2: Companies including LipiRNA Technologies, NOF America Corporation, and Avanti Polar Lipids supply the pharmaceutical-grade lipids necessary for LNP formulation.

Q3: Are there dedicated contract manufacturers for Amvuttra?
A3: Yes, leading CMOs such as Catalent and Baxter assist in formulation, fill-finish, and packaging processes for Amvuttra.

Q4: How is the distribution of Amvuttra managed globally?
A4: Specialized logistics providers like DHL, UPS Healthcare, and FedEx ensure temperature-controlled, global distribution, often through regional distribution partners.

Q5: What trends are shaping the future supply chain of RNA-based drugs like Amvuttra?
A5: Vertical integration, diversification of suppliers, technological innovations in delivery methods, and supply chain resilience are key future trends.

---

References

1. Alnylam Pharmaceuticals Reports. Vutrisiran (Amvuttra) Overview. [2023].
2. Eurofins Genomics. Oligonucleotide manufacturing capabilities. [2023].
3. TriLink BioTechnologies. Modified Nucleotides and Oligonucleotide Production. [2023].
4. LipiRNA Technologies. LNP Components for RNA Therapeutics. [2023].
5. Regulatory guidelines on biologic manufacturing and distribution. FDA and EMA.