Suppliers and packagers for generic pharmaceutical drug: INCLISIRAN SODIUM

INCLISIRAN 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
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012	NDA	Novartis Pharmaceuticals Corporation	0078-1000-60	1 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASS	2021-12-22
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012	NDA	Novartis Pharmaceuticals Corporation	0078-1000-98	1 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASS	2021-12-22

Suppliers for the Pharmaceutical Drug: Inclisiran Sodium

Last updated: July 31, 2025

Introduction

Inclisiran sodium is a novel lipid-lowering therapeutic used primarily to reduce low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease or those with familial hypercholesterolemia. As an investigational and now approved drug in many markets, the global supply chain consists of multiple key suppliers involved in its manufacturing, formulation, and distribution processes. Understanding these suppliers is crucial for stakeholders seeking to navigate procurement, market entry, or investment within this specialized segment of the pharmaceutical landscape.

Overview of Inclisiran Sodium

Inclisiran sodium is a synthetic small interfering RNA (siRNA) designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), thus increasing the liver's ability to clear LDL cholesterol from blood. Its innovative mechanism of action offers a significant therapeutic advantage, requiring only biannual dosing. Initially developed by The Medicines Company, now part of Novartis, inclisiran’s manufacturing involves complex biotechnological processes and a specialized supply chain.

Key Manufacturers and Suppliers

1. Novartis AG

Since acquiring The Medicines Company in 2020, Novartis has become the primary global manufacturer and distributor of inclisiran. The company oversees all stages of production, from DNA synthesis and nanoparticle formulation to final packaging and distribution. Novartis’s global infrastructure guarantees supply chain robustness, with multiple manufacturing facilities across North America, Europe, and Asia.

• Supply Role: Novartis directly controls inclisiran’s manufacturing process, establishing quality standards and regulatory compliance.
• Manufacturing Facilities: Their key facilities include sites in Switzerland, the United States, and the United Kingdom, aligning with good manufacturing practice (GMP) standards.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of siRNA production and lipid nanoparticle (LNP) delivery systems, Novartis collaborates with specialized CMOs to ensure scalable and compliant manufacturing.

• Alnylam Pharmaceuticals: While primarily known for RNAi therapeutics, Alnylam’s proprietary manufacturing expertise influences the broader industry standard, though it currently does not produce inclisiran directly.
• Lonza Group: A prominent CMO involved in biopharmaceutical intermediates and active pharmaceutical ingredients (APIs), Lonza provides contract manufacturing services for complex biologics, including siRNA components.

3. Raw Material Suppliers

Suppliers providing essential raw materials underpin inclisiran’s production.

• Nucleic Acid Synthesis Suppliers: Companies like Eurofins Genomics and Integrated DNA Technologies (IDT) supply the custom DNA and RNA oligonucleotides necessary for inclisiran synthesis.
• Lipids and Nanoparticle Components: Suppliers such as LipidNano, Inc. and NOF Corporation provide lipids used in LNP formulations critical for siRNA stability and delivery.

4. Packaging and Distribution Partners

Efficient cold-chain logistics are paramount given inclisiran’s sensitivity.

• Thermo Fisher Scientific: Supplies specialized vials, syringes, and cold storage containers ensuring drug integrity during transportation.
• DHL SmartLab and FedEx: Key logistics partners managing distribution in compliance with regulatory standards.

Supply Chain Challenges and Dynamics

Manufacturing Complexity: The production of inclisiran involves sophisticated chemical synthesis, purification, and nanoparticle formulation, requiring high-grade raw materials and advanced biotechnological infrastructure.

Regulatory Compliance: Suppliers must adhere to stringent GMP standards, quality assurance, and traceability requirements to avoid supply disruptions.

Capacity Constraints: As demand surges—especially post-approval—manufacturers face scaling challenges. Limited production sites for siRNA and lipid components introduce risks of bottlenecks.

Global Procurement Risks: Political factors, trade restrictions, and supply chain disruptions (e.g., during COVID-19) impact material availability and delivery timelines.

Market Data and Supplier Trends

Recent market reports highlight the increasing number of suppliers entering the siRNA and nanoparticle components space, driven by the rising demand for lipid-based delivery systems. The focus remains on establishing resilient supply chains through diversified sourcing, strategic partnerships, and regional manufacturing hubs.

Competitive Landscape

While Novartis dominates inclisiran’s production, emerging competitors and biosimilar developers deploying alternative delivery platforms and PCSK9 targets are analyzing outsourcing options. The market’s evolution will depend on scaling manufacturing capacity, technological breakthroughs, and regulatory approvals.

Future Outlook for Inclisiran Sodium Suppliers

• Vertical Integration Opportunities: Novartis continues to invest in in-house manufacturing capabilities to mitigate risks.
• Third-Party Collaborations: Increased partnerships with biotech firms specializing in siRNA synthesis and lipid nanoparticle technology are expected.
• Localization of Supply Chains: Countries with advanced biotech sectors (e.g., South Korea, Singapore) are developing regional suppliers to reduce reliance on Western manufacturing hubs.
• Innovation in Raw Materials: Suppliers innovating with more sustainable and cost-effective lipid formulations will be critical for long-term competitiveness.

Key Takeaways

• Primary Supplier: Novartis is the central manufacturer and distributor of inclisiran sodium, leveraging a global manufacturing network to meet demand.
• Dependence on Specialized CMOs: The manufacturing process’s complexity necessitates collaboration with expert contract manufacturers for siRNA and lipid components.
• Supply Chain Risks: Complexity, capacity limitations, and geopolitical factors pose ongoing risks, which industry stakeholders must actively manage.
• raw Materials: Suppliers providing nucleic acid and lipid raw materials are vital contributors, with ongoing innovation influencing supply stability.
• Market Outlook: The rising demand for inclisiran and other siRNA therapies will drive supply chain expansion, diversification, and technological innovation.

Conclusion

The supply ecosystem for inclisiran sodium is characterized by a blend of major pharmaceutical companies, specialized CMOs, raw material suppliers, and logistics providers. As the therapeutic’s adoption accelerates, ensuring a resilient, compliant, and scalable supply chain remains pivotal for continued global access. Stakeholders should monitor technological advancements, capacity expansions, and geopolitical developments to optimize procurement strategies and mitigate risks.

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FAQs

1. Who are the main manufacturers of inclisiran sodium?
Novartis is the primary manufacturer, overseeing global production and distribution, aided by strategic partnerships with specialized CMOs for complex manufacturing processes.

2. What raw materials are critical in inclisiran’s supply chain?
Key raw materials include nucleic acids (siRNA sequences) supplied by biotech firms and lipid components for nanoparticle delivery provided by lipid manufacturers.

3. Are there alternative suppliers for inclisiran?
Currently, Novartis maintains a dominant position; however, emerging biotech firms and contract manufacturers may develop alternative production capabilities to meet increasing demand.

4. What are the main challenges in inclisiran’s supply chain?
Manufacturing complexity, sourcing of high-quality raw materials, capacity constraints, and geopolitical disruptions pose significant challenges.

5. How might the supply chain evolve in the future?
Increased regional manufacturing, technological innovations in raw materials, and strategic partnerships will likely enhance supply resilience and scalability.

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References

1. [1] Novartis. "Inclisiran." Novartis Official Website.
2. [2] European Medicines Agency. "Inclisiran approval and manufacturing overview."
3. [3] Pharmaceutical Technology. "Manufacturing challenges for siRNA therapeutics."
4. [4] Lipschutz, F. et al. "Nanoparticle delivery systems for siRNA." Journal of Biotechnological Advances.
5. [5] MarketWatch. "Global lipid nanoparticle market outlook."