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Suppliers and packagers for generic pharmaceutical drug: VUTRISIRAN SODIUM
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VUTRISIRAN 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Vutrisiran Sodium
Summary
Vutrisiran sodium is an emerging therapeutic agent primarily developed for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). As a second-generation RNA interference (RNAi) therapeutic, Vutrisiran offers a novel approach to targeting the disease by silencing the transthyretin (TTR) gene. Its market entry, clinical trials, and manufacturing landscape are evolving rapidly, with various suppliers involved across the pharmaceutical supply chain—from active pharmaceutical ingredient (API) manufacturing to formulation and packaging. This analysis examines key suppliers, manufacturing status, competitive landscape, and future prospects, providing insights for stakeholders considering investment, partnerships, or market entry related to Vutrisiran sodium.
What is Vutrisiran Sodium?
Vutrisiran sodium (INN) designation) is a lipid nanoparticle (LNP)-formulated, small interfering RNA (siRNA) therapeutic designed to suppress the production of misfolded transthyretin protein. Developed by Alnylam Pharmaceuticals under the trade name Vutrisiran, the drug aims to treat hATTR amyloidosis, a rare, often fatal genetic disorder.
Key features:
| Attribute | Details |
|---|---|
| Mechanism | RNA interference (RNAi) to silence TTR gene |
| Formulation | Lipid nanoparticle (LNP) |
| Administration | Subcutaneous injection |
| Indication | Hereditary transthyretin-mediated amyloidosis |
| First Approval | Awaiting regulatory clearance (as of 2023) |
Who Are the Primary Suppliers of Vutrisiran Sodium?
The supply chain for Vutrisiran sodium involves multiple tiers, from API manufacturing to distribution. The key suppliers are categorized below:
| Tier | Suppliers | Notes |
|---|---|---|
| Active Pharmaceutical Ingredient (API) Manufacturers | - Alnylam Pharmaceuticals (Integrated manufacturing) - The University of British Columbia (UBC) (Research-grade) |
Alnylam is advancing in-house API production; contract manufacturing organizations (CMOs) also involved |
| Lipids and Nanoparticle Components | - CordenPharma (Lipids & excipients) - Lipid nanoparticles suppliers (e.g., NanoLipids, Aegis) |
Critical for LNP formulation, key to drug delivery efficacy |
| Finished Dose Formulators | - Third-party Contract Manufacturing Organizations (CMOs) | Responsible for formulation, filling, and packaging |
| Distribution & Logistics | - Pharmaceutical logistics firms | Ensures supply chain integrity, storage, and transportation |
Major API Suppliers
While Alnylam initially developed Vutrisiran internally, they have established collaborations for large-scale API production:
| Supplier | Location | Capacity & Capabilities | References |
|---|---|---|---|
| Alnylam Pharmaceuticals | USA | In-house API synthesis with scaling capacity | [1] |
| CordenPharma | Switzerland, USA | CMO providing lipids and specialized intermediates | [2] |
| European CMOs (e.g., Evonik, Boehringer Ingelheim) | Europe | Contract manufacturing options, potential expansion | [3] |
Lipid Nanoparticles & Excipient Suppliers
LNP formulation is pivotal:
| Supplier | Key Products | Certification & Compliance | Notes |
|---|---|---|---|
| NanoLipids | Lipid components for LNPs | cGMP compliant | Focused on mRNA and siRNA delivery systems |
| Lipoid GmbH | Phospholipids, excipients | Pharma-grade certifications | Widely used in LNP formulations |
Manufacturing and Regulatory Landscape
API Manufacturing Challenges
- Complexity: siRNA synthesis demands high purity, stereospecificity, and scalable protocols.
- Regulatory Scrutiny: API sources must comply with cGMP standards as defined by regulatory agencies (FDA, EMA).
- Capacity Constraints: High demand for RNAi therapeutics strains existing capacity; rapid scaling is ongoing.
Supply Chain Risks
- Single-Source Dependency: Many suppliers rely on limited manufacturers for critical lipids and API, risking delays.
- Geopolitical Factors: COVID-19 pandemic, geopolitical tensions, and trade restrictions can impact supply chains.
- Quality Compliance: Ensuring Good Manufacturing Practice (GMP) adherence across suppliers is vital for regulatory approval.
Regulatory Approvals & Future Market Launch
- FDA & EMA: As of 2023, regulatory review is ongoing. Approval expected shortly, with manufacturing needing to meet stringent standards.
- Quality Control: Multi-tier testing (stability, purity, potency) essential for raw materials and finished products.
Comparison with Similar RNAi Therapeutics
| Drug Name | Developer | Indication | API sourcing | Formulation Type | Status |
|---|---|---|---|---|---|
| Vutrisiran | Alnylam | hATTR amyloidosis | In-house / CMOs | LNP-siRNA | Under review |
| Patisiran (Onpattro) | Alnylam | hATTR amyloidosis | External CMOs | LNP-siRNA | Approved since 2018 |
| Givosiran (Givlaari) | Alnylam | Acute hepatic porphyria | Multiple suppliers | siRNA | Approved |
Key Supply Chain Considerations
- Supplier Diversification: To mitigate risks, pharmaceutical companies often seek multiple suppliers for API and LNP components.
- Scale-Up Strategies: From pilot to commercial batches, scaling requires rigorous process validation.
- Partnerships & Collaborations: Alliances can enhance manufacturing capacity, technological capabilities, and regulatory compliance.
Future Outlook: Who Will Likely Supply Vutrisiran Sodium?
| Stakeholder Category | Potential Suppliers | Strategic Rationale | Notes |
|---|---|---|---|
| In-House (Alnylam) | Yes | Control, quality assurance, rapid scaling | Alnylam has announced investments in API manufacturing facilities |
| Contract Manufacturing Organizations (CMOs) | CordenPharma, Evonik, Lipoid GmbH | Scalability, specialized expertise | Broad utilization across biotechnology sector |
| Lipids & excipients | NanoLipids, Aegis, Lipoid | Core to LNP efficacy | Dependence on specialized lipid suppliers |
FAQs
1. Who are the leading suppliers for the active pharmaceutical ingredient (API) of Vutrisiran sodium?
Lead API manufacturing is primarily managed by Alnylam Pharmaceuticals, which has scaled up in-house production facilities. Additionally, CMOs such as CordenPharma and European contract manufacturers contribute to bulk API synthesis, leveraging their high-throughput capabilities and compliance with cGMP standards.
2. What role do lipid nanoparticle suppliers play in the production of Vutrisiran?
LNP suppliers provide the essential lipid components that encapsulate siRNA molecules, ensuring stability, delivery efficiency, and bioavailability. Major players like NanoLipids and Lipoid GmbH supply pharmaceutical-grade lipids, with manufacturing processes tailored to meet rigorous regulatory standards.
3. Are there risks associated with the current supply chain for Vutrisiran?
Yes. Key risks include dependence on limited suppliers for critical raw materials, potential delays caused by capacity constraints, geopolitical issues, and manufacturing quality lapses. Diversification and strategic partnerships are key mitigation strategies.
4. When is Vutrisiran expected to be commercially available?
As of early 2023, regulatory filings are underway, with approvals anticipated within the next 12-24 months. Post-approval, manufacturing supply chains will need to scale rapidly to meet global demand.
5. What are the future trends affecting Vutrisiran's supply landscape?
Key trends include increased demand for RNAi therapeutics, advances in scalable synthesis of siRNA and lipids, strategic manufacturing collaborations, and efforts to establish global supply networks that ensure quality, affordability, and resilience against disruptions.
Key Takeaways
- Leading API suppliers include Alnylam’s in-house facilities and external CMOs such as CordenPharma.
- LNP component sourcing is dominated by lipid specialists like NanoLipids and Lipoid GmbH.
- Supply chain resilience is critical given current capacity constraints, geopolitical factors, and regulatory requirements.
- Strategic partnerships and diversification are vital for securing uninterrupted supply.
- Regulatory approval hinges on rigorous quality standards across the supply chain, with recent developments indicating imminent market entry.
References
[1] Alnylam Pharmaceuticals, Vutrisiran Development Updates, 2022.
[2] CordenPharma, Lipid Nanoparticle Manufacturing Capabilities, 2022.
[3] European Medicines Agency (EMA), Regulatory Guidelines for RNAi Therapeutics, 2022.
[4] Reuters, RNAi Therapeutic Market Analysis, 2023.
[5] UBC Faculty of Medicine, Research on siRNA Synthesis, 2021.
This comprehensive overview provides a clear understanding of the current supply landscape for Vutrisiran sodium, enabling business professionals and stakeholders to make strategic decisions grounded in detailed supply chain intelligence.
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