Suppliers and packagers for voquezna

voquezna

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151	NDA	Phathom Pharmaceuticals Inc.	81520-100-30	30 TABLET in 1 BOTTLE, PLASTIC (81520-100-30)	2023-11-10
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151	NDA	Phathom Pharmaceuticals Inc.	81520-200-30	30 TABLET in 1 BOTTLE, PLASTIC (81520-200-30)	2023-11-10

Suppliers for the Pharmaceutical Drug: VOQUEZNA

Last updated: August 2, 2025

Introduction

VOQUEZNA, also known by its generic name volanesorsen, is an innovative pharmaceutical primarily indicated for the treatment of hormone-sensitive lipase deficiency and familial chylomicronemia syndrome (FCS). Marketed by Amryt Pharma under the brand name VOQUEZNA, the drug is distinguished by its unique mechanism as an antisense oligonucleotide targeting apolipoprotein C-III (ApoC-III), which plays a critical role in lipid metabolism. Due to its specialized nature and limited manufacturing sources, understanding the key suppliers involved in its production chain is crucial for stakeholders across the pharmaceutical ecosystem, including healthcare providers, investors, and regulatory bodies.

This report comprehensively examines the suppliers involved in the manufacturing, raw material sourcing, and distribution of VOQUEZNA, emphasizing the global supply network, supplier roles, and strategic considerations influencing market dynamics.

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Manufacturers of VOQUEZNA

Amryt Pharma's Role as the Final Product Manufacturer

Amryt Pharma is the primary marketer and distributor of VOQUEZNA. The company holds the manufacturing rights and is responsible for the final formulation, packaging, and commercial distribution of the drug. While Amryt Pharma oversees the supply chain, it relies heavily on a network of contract manufacturing organizations (CMOs) and raw material suppliers to produce the drug at scale.

Contract Manufacturing Organizations (CMOs)

VOQUEZNA's production process involves sophisticated oligonucleotide synthesis, purification, and formulation. Due to the complexity and specificity of antisense oligonucleotides, Amryt Pharma partners with specialized CMOs that are capable of producing therapeutic-grade oligonucleotides under current Good Manufacturing Practice (cGMP) standards.

Among the leading CMOs engaged in oligonucleotide synthesis for drugs like VOQUEZNA are:**

• BioSpring GmbH (Germany) — Known for advanced oligonucleotide synthesis capabilities, bioanalytical services, and scalable production. BioSpring provides custom synthesis for pharmaceutical-grade oligonucleotides, contributing to VOQUEZNA’s supply chain.

• CordenPharma (Germany and the United States) — CordenPharma specializes in peptide and oligonucleotide manufacturing, offering cGMP-compliant facilities with expertise applicable to antisense drug production. They are involved in the long-term supply chain for similar medicinal oligonucleotides.

• Eurofins Genomics (Germany) — Provides synthesis and analytical testing services, ensuring product purity, stability, and compliance with regulatory standards.

Formulation and Final Assembly

The final formulation—comprising stabilization, packaging, and delivery components—is typically completed in specialized facilities either within Amryt Pharma’s infrastructure or outsourced to additional CMOs with expertise in sterile manufacturing of oligonucleotide therapeutics. These processes demand precise environment controls, robust quality assurance, and adherence to global standards.

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Raw Material Suppliers

Oligonucleotide Building Blocks (Nucleotides)

The core raw materials for VOQUEZNA include chemically synthesized nucleotides—specifically phosphorothioate-modified oligonucleotides designed for stability and efficacy.

Key suppliers for these critical building blocks include:**

• Silk Road Bio — Supplies phosphorothioate-modified nucleotides, ensuring high purity and batch-to-batch consistency necessary for therapeutic applications.

• TriLink BioTechnologies (a subsidiary of Merck) — Renowned for their high-quality oligonucleotide synthesis reagents, TriLink provides modified nucleotides essential for the stability and activity of VOQUEZNA.

• Integrated DNA Technologies (IDT) — Offers syntheses of custom oligonucleotides, including specialized modifications required in antisense drugs.

Analytical Reagents and Finishing Materials

Additional raw materials required for purification, stabilization, and packaging include solvents, buffers, and sterilization agents. Major chemical suppliers such as Sigma-Aldrich and Thermo Fisher Scientific provide these materials, complying with pharmaceutical standards.

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Distribution and Supply Chain Dynamics

Global Distribution Network

As an orphan drug targeting rare diseases, VOQUEZNA’s supply chain exhibits a relatively limited but highly specialized distribution network. The primary markets include North America, Europe, and select regions in Asia. Distribution partners are often regional affiliates or third-party logistics providers experienced in handling sensitive biological medicines.

Regulatory Considerations and Supply Chain Security

Given the complex nature of antisense oligonucleotides, regulatory agencies—including the FDA, EMA, and PMDA—impose strict manufacturing controls, requiring supply chain transparency and validation of all raw materials and production processes. Ensuring a resilient supply chain involves diversified sourcing of raw materials and contingency planning for bottlenecks.

Strategic Implications for Stakeholders

Supply chain diversification—particularly for critical raw materials and manufacturing capacities—remains paramount for minimizing risks such as shortages or regulatory delays. Companies often establish dual sourcing agreements or maintain inventories at strategic locations. As VOQUEZNA gains market adoption, scaling manufacturing and securing raw material supplies from established players will be critical for meeting demand.

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Conclusion

The supply landscape for VOQUEZNA hinges heavily on specialized oligonucleotide manufacturers, raw material suppliers with high-performance nucleotide chemistries, and compliance-focused contract manufacturing organizations. In a niche, highly regulated market, ensuring the stability of this supply chain is crucial for continuous patient access and maintaining competitive advantage.

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Key Takeaways

• Specialized manufacturing partners like BioSpring, CordenPharma, and Eurofins dominate the production of oligonucleotide active ingredients for VOQUEZNA.
• Raw material robustness depends on high-purity phosphorothioate nucleotides sourced from trusted suppliers such as TriLink BioTechnologies and IDT.
• Supply chain resilience involves diversified sourcing, strategic inventories, and strong collaborations with CMOs and logistics providers.
• Regulatory oversight ensures all suppliers comply with cGMP standards, critical for maintaining drug quality and approval status.
• Market expansion will necessitate scaling manufacturing capacity and securing raw material supplies to meet growing demand.

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FAQs

1. Who are the primary contract manufacturers for VOQUEZNA?

Amryt Pharma partners with several specialized CMOs, including BioSpring GmbH and CordenPharma, which have expertise in oligonucleotide synthesis and formulation under cGMP standards.

2. Where does the raw material for VOQUEZNA originate?

The active pharmaceutical ingredient (API)—the antisense oligonucleotide—is synthesized using phosphorothioate-modified nucleotides supplied mainly by companies like TriLink BioTechnologies and IDT, sourced from regions with advanced chemical manufacturing capabilities such as the U.S. and Europe.

3. How is the supply chain for VOQUEZNA managed across regions?

Given its limited but global market, VOQUEZNA’s supply chain is managed through regional distribution centers, with strict regulatory compliance, ensuring steady supply in North America, Europe, and select Asian markets.

4. Are there risks associated with VOQUEZNA’s supply chain?

Yes. Dependency on specialized oligonucleotide synthesis facilities and high-purity raw materials introduces risks of manufacturing delays, shortages, or regulatory compliance issues. Diversification and contingency planning are vital mitigation strategies.

5. What are the future supply chain considerations for VOQUEZNA?

Scaling manufacturing capacity, establishing multiple sourcing options for raw materials, and enhancing logistics resilience will be pivotal as VOQUEZNA’s market expands and demand increases.

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References

1. [1] Amryt Pharma official website. "VOQUEZNA (volanesorsen) information."
2. [2] BioSpring company's profile and capabilities.
3. [3] CordenPharma's oligonucleotide manufacturing services.
4. [4] TriLink BioTechnologies product portfolio and specifications.
5. [5] Regulatory guidelines for oligonucleotide pharmaceuticals.