Suppliers and packagers for LEQVIO

LEQVIO

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 Leqvio (Inclisiran)

Last updated: February 19, 2026

Leqvio (inclisiran) is a lipid-lowering agent developed by Novartis, used primarily to reduce LDL cholesterol levels in adults. Its manufacturing and supply chain involve multiple contract manufacturing organizations (CMOs), raw material providers, and distribution partners.

Key Suppliers and Manufacturing Components

Active Pharmaceutical Ingredient (API) Production

• Novartis: Owns the rights to inclisiran and oversees API development.

• CMOs: Several manufacturing facilities globally produce inclisiran API.

  • Thermo Fisher Scientific: Reports indicate involvement in oligonucleotide manufacturing, including inclisiran APIs.
  • SIMAY: Likely provides custom oligonucleotide synthesis services.
  • WuXi Biologics: Has capacity for oligonucleotide synthesis, potentially supplying raw materials or manufacturing APIs.

Formulation and Final Dosage Production

• Novartis: Manufactures the finished drug at its plants, including the sterile injectable formulation.
• Contract Developers: Some production components may be outsourced to specialized pharmaceutical manufacturers.

Raw Material Suppliers

• Phosphoramidites and Oligonucleotide Precursors: Multiple chemical suppliers supply raw materials, such as:
  • ChemGenes Corporation
  • SINTEF (Norway)
  • Corning and Merck: Supply reagents for oligonucleotide synthesis.
• Modified Nucleotides: Suppliers like TriLink BioTechnologies provide modified nucleotides integral to inclisiran.

Distribution Partners

• Novartis Distribution: Handles global distribution logistics directly or via authorized partners.
• Third-party Logistics (3PL): Involves specialized pharma logistics firms, such as DHL or McKesson, depending on regional markets.

Supply Chain Characteristics

• Vertical Integration: Novartis maintains control over core manufacturing, including API synthesis, formulation, and final packaging.
• Global Sourcing: Raw materials sourced from multiple vendors across North America, Asia, and Europe to mitigate risks.
• Regulatory Oversight: Suppliers must comply with Good Manufacturing Practices (GMP) approved by agencies like the FDA, EMA, or local authorities.

Supply Chain Risks and Constraints

• API Manufacturing Bottlenecks: Oligonucleotide synthesis complexity can cause delays.
• Raw Material Availability: Scarcity or regulatory restrictions on specialized nucleotides can impact production.
• Regulatory Changes: Stringent compliance affects supplier operations and quality standards.
• Global Events: Supply disruptions from geopolitical or pandemic-related factors impact delivery schedules.

Market Entry and Competition

• Novartis maintains tight control over API and formulation production, restricting supply chain transparency.
• Alternative suppliers for raw materials operate primarily in Asia; competition exists for oligonucleotide synthesis capacity.
• No known third-party manufacturers currently produce commercial quantities of inclisiran for global distribution outside Novartis's integrated supply chain.

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Key Takeaways

• Novartis directly manages API, formulation, and distribution processes for Leqvio.
• Major raw material suppliers include specialized oligonucleotide and nucleotide providers.
• The supply chain involves multiple regional vendors, with mitigation strategies for supply risks.
• Production bottlenecks revolve around complex oligonucleotide manufacturing needs.

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FAQs

1. Who manufactures the active pharmaceutical ingredient (API) for Leqvio?
Novartis oversees API production, sourcing from CMOs like Thermo Fisher Scientific and WuXi Biologics.

2. Are there alternative suppliers for inclisiran API?
Currently, Novartis controls API manufacturing. While raw materials are sourced from multiple vendors, no alternative API manufacturers are publicly known.

3. What raw materials are critical for inclisiran manufacturing?
Modified nucleotides and phosphoramidites are essential, supplied mainly by specialized vendors such as TriLink and ChemGenes.

4. How does supply chain risk affect Leqvio availability?
Complex oligonucleotide synthesis, raw material scarcity, and geopolitical issues can cause delays or shortages.

5. Are there regional differences in supply chain partners?
Yes; raw materials and manufacturing vary regionally, with Asia supplying key oligonucleotide precursors and North American/EU-based facilities providing final formulation and packaging.

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References

[1] Novartis. (2023). Leqvio (Inclisiran) Summary of Product Characteristics.
[2] FDA. (2023). Good Manufacturing Practice Regulations.
[3] WuXi Biologics. (2022). Capabilities in Oligonucleotide Synthesis.
[4] TriLink BioTechnologies. (2023). Modified Nucleotides for Pharmaceuticals.
[5] ChemGenes Corporation. (2022). Oligonucleotide Reagents Supply.