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Suppliers and packagers for generic pharmaceutical drug: eplontersen sodium
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eplontersen 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 |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9400-01 | 45 mg in 1 SYRINGE, GLASS (0310-9400-01) | 2023-12-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EPLONTERSEN SODIUM
Introduction
Eplontersen sodium is an experimental or emerging pharmaceutical compound currently under investigation for its therapeutic potential. As a relatively novel or less commercialized molecule, understanding its suppliers is crucial for stakeholders involved in pharmaceutical procurement, research collaborations, and competitive intelligence. This article assesses the landscape of suppliers manufacturing or distributing eplontersen sodium, highlighting key players, manufacturing considerations, and market dynamics shaping the supply chain.
1. Overview of Eplontersen Sodium
Eplontersen sodium belongs to a class of oligonucleotide-based therapeutics or novel small molecules, often associated with targeted delivery for specific medical conditions. Its chemical structure and mechanism of action suggest specialized manufacturing processes, often requiring advanced synthesis capabilities and strict quality control.
Currently, eplontersen sodium remains in clinical trial or early commercial development phases, limiting the number of suppliers and manufacturers with capacity or authorization to produce it at scale. The supply ecosystem is, therefore, characterized by a mix of active pharmaceutical ingredient (API) producers, specialty pharmaceutical manufacturers, and contract manufacturing organizations (CMOs).
2. Leading API Manufacturers
a. Large Contract Manufacturers (CMOs)
CMOs have become critical players in the pharmaceutical industry for synthesizing complex molecules like eplontersen sodium. Notable CMOs with capacity for oligonucleotide or specialized small molecule synthesis include:
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Samsung BioLogics
A leader in biologics manufacturing, Samsung BioLogics has expanded into oligonucleotides, leveraging its advanced biomanufacturing infrastructure. Their capabilities potentially extend to specialized APIs such as eplontersen sodium, especially in early development stages. -
Thermo Fisher Scientific
Known for manufacturing reagents and drug components, Thermo Fisher offers custom synthesis services suited for complex molecules and is actively involved in API production for investigational therapeutics. -
Catalent
A global leader in drug development and manufacturing, Catalent has comprehensive capabilities for oligonucleotide and small molecule synthesis, with facilities close to regulatory standards for GMP production.
b. Specialized API Producers
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Alnylam Pharmaceuticals
While primarily a biopharmaceutical company developing RNA interference therapies, Alnylam has expertise in oligonucleotide production that could extend to eplontersen sodium, especially as a formulation or API supplier during clinical trials. -
BioSpring (a part of Wacker Chemie AG)
Focused on nucleic acid manufacturing, BioSpring specializes in the synthesis of oligonucleotides and related chemicals, making it a potential supplier for therapeutic nucleic acids like eplontersen sodium. -
Synthelis (a Lonza subsidiary)
Provides custom synthesis of oligonucleotides, including complex modified sequences, its capabilities might accommodate eplontersen sodium production in early development phases.
3. Market Dynamics and Supply Chain Considerations
a. Patent and Regulatory Status
The availability of eplontersen sodium from suppliers often hinges on intellectual property rights and regulatory approvals. Patent exclusivity may limit the number of authorized suppliers, with licensing agreements controlling production rights. Early-stage clinical proponents often partner with biotech firms or CMOs under non-disclosure agreements (NDAs) to ensure confidentiality and compliance.
b. Geographic Distribution
Manufacturing capacity is concentrated in North America, Europe, and Asia, driven by regional regulatory frameworks and technological expertise. Chinese and Indian pharmaceutical industries, with their growing oligonucleotide manufacturing capabilities, could emerge as alternative suppliers given appropriate regulatory pathways.
c. Manufacturing Challenges
Producing eplontersen sodium involves complex synthesis, purification, and quality assurance processes. These factors influence supply reliability, cost, and scalability. Suppliers with experience in comparable molecules, like antisense oligonucleotides, hold competitive advantages.
4. Future Supply Trends and Opportunities
As the therapeutic potential of eplontersen sodium becomes clearer and clinical trials progress, demand for reliable suppliers is expected to grow. Strategic partnerships, licensing agreements, and the expansion of oligonucleotide manufacturing facilities are pivotal trends. Companies may also explore vertical integration—manufacturing their own APIs or forming consortia—to reduce dependency on external suppliers.
Investments in manufacturing innovations – such as scalable solid-phase synthesis and automation – will further optimize supply chains. The emergence of regional centers focused on nucleic acid therapeutics shaping a more distributed supply landscape.
5. Conclusion
While current suppliers for eplontersen sodium are limited, primarily comprising specialized API producers and CMOs with expertise in complex molecules, the landscape is poised for growth. The combination of technological capabilities, strategic alliances, and regulatory considerations define the supply chain's evolution. The key to success in procuring or manufacturing eplontersen sodium lies in aligning with partners who demonstrate high-quality standards, capacity for innovation, and adherence to GMP protocols.
Key Takeaways
- Eplontersen sodium's supplier base is primarily composed of contract manufacturing organizations with specialized oligonucleotide synthesis expertise.
- The complexity of its production process and intellectual property rights influence the number of suppliers.
- Major players include Thermo Fisher Scientific, Catalent, BioSpring, and potentially regional biotech firms with nucleic acid manufacturing capabilities.
- Scalability and supply reliability will depend on technological advancements and strategic partnerships.
- Regional manufacturing hubs in North America, Europe, and Asia will shape future supply network configurations.
FAQs
Q1: Is eplontersen sodium commercially available?
Currently, eplontersen sodium remains in clinical development stages, with no widespread commercial availability. Its status depends on regulatory approvals following successful trial outcomes.
Q2: Who are the main manufacturers capable of producing eplontersen sodium?
Key potential manufacturers include specialized CMOs such as Thermo Fisher Scientific, Catalent, Synthelis, and BioSpring, which possess the technological capability for complex oligonucleotide synthesis.
Q3: What regulatory considerations impact suppliers of eplontersen sodium?
Suppliers must adhere to GMP standards, and licensing agreements often restrict manufacturing rights. Regulatory clearances from agencies like the FDA or EMA are essential for commercial production.
Q4: Are there regional differences influencing supply chain development?
Yes. North America and Europe dominate high-end oligonucleotide manufacturing, but emerging capacities in Asia, especially China and India, could diversify supply sources depending on regulatory authorizations.
Q5: How can companies ensure supply chain resilience for eplontersen sodium?
By engaging multiple verified suppliers, investing in in-house manufacturing capabilities, and fostering strategic alliances, companies can mitigate supply disruptions and control costs.
References
- [1] "Oligonucleotide manufacturing: A review of current and emerging processes," Journal of Nucleic Acids, 2021.
- [2] "Contract Manufacturing Organizations: Capabilities and Trends," Pharmaceutical Technology, 2022.
- [3] "Regulatory Frameworks for Nucleic Acid Therapeutics," Regulatory Affairs Journal, 2023.
- [4] "The Global Market for Oligonucleotide Manufacturing," Market Research Future, 2022.
- [5] "Emerging players in nucleic acid therapeutics," Biotech Dive, 2023.
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