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

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Leqvio

Introduction
Leqvio (inclisiran) is an innovative lipid-lowering agent developed by Novartis, designed to reduce low-density lipoprotein cholesterol (LDL-C) levels. Approved for clinical use in various regions, including the US and Europe, Leqvio’s unique mechanism involves small interfering RNA (siRNA) technology that targets PCSK9 mRNA, leading to decreased LDL receptor degradation (1). As a relatively recent entrant in the cardiovascular therapeutics market, understanding the key suppliers involved in the production and distribution of Leqvio is crucial for stakeholders across the supply chain, including manufacturers, distributors, and healthcare providers.

Manufacturing of Active Pharmaceutical Ingredient (API)
The core component of Leqvio is inclisiran, a synthetic siRNA molecule. The production of inclisiran involves sophisticated manufacturing processes for nucleic acid synthesis, stabilization, and formulation. Given Novartis’s strategic approach, the company retains tight control over its manufacturing facilities, primarily sourcing raw materials and components from specialized suppliers domestically and internationally.

Raw Material Suppliers
Inclisiran’s manufacturing requires high-purity phosphoramidites, nucleoside triphosphates, and specialized lipids. Suppliers include firms specializing in API intermediates, such as:

• Chemical providers for nucleoside synthesis: Companies like Thermo Fisher Scientific and Merck KGaA supply high-quality phosphoramidites and nucleotide intermediates used in siRNA synthesis (2).
• Lipids and delivery excipients: Lipids used in the nanoparticle delivery system are provided by specialized suppliers such as Avanti Polar Lipids and Lipoid GmbH, which supply phospholipids and cholesterol essential for lipid nanoparticle formulation.

Contract Manufacturing Organizations (CMOs)
Novartis’s scale-up and manufacturing of inclisiran are supported by contract manufacturing organizations with expertise in nucleic acid synthesis and nanoparticle formulation. Known players potentially involved include:

• CordenPharma and BioSpring: Both have demonstrated capabilities in nucleic acid API production and may serve as strategic partners (3).
• Selexis or Samsung Biologics: While traditionally associated with protein-based drugs, such firms are increasingly branching into nucleic acid therapeutics.

Formulation and Packaging
Leqvio is supplied as a sterile, preservative-free subcutaneous injection. Formulation involves integrating the siRNA into nanoparticles, often utilizing lipid excipients supplied by firms like:

• Lipid suppliers: Lipoid GmbH, Avanti Polar Lipids, and other lipid manufacturers provide the necessary components for nanoparticle encapsulation.
• Vial and packaging suppliers: Companies like West Pharmaceuticals or Stevanato Group provide sterile vials and packaging services compliant with pharmaceutical standards.

Distribution and Supply Chain
Once manufactured, Leqvio’s distribution depends on Novartis’s global logistics network, which includes authorized distributors and wholesalers. The supply chain involves:

• Global wholesalers (e.g., McKesson, Cardinal Health, Alliance Healthcare): Ensuring broad access across healthcare facilities.
• Customs and regulatory clearance: Essential for international markets, handled by Novartis’s regulatory teams with support from logistics providers.
• On-site storage: Temperature-controlled logistics are critical, given the drug’s stability profile, necessitating specialized cold chain providers.

Regulatory and Quality Assurance Suppliers
Maintaining compliance involves collaboration with quality assurance providers, including third-party testing laboratories that verify the purity, stability, and potency of each batch according to pharmacopeial standards (4).

Key Players and Strategic Partnerships
Although Novartis maintains primary control over drug development and manufacturing, it collaborates with specialized suppliers and CMOs. These strategic partnerships ensure supply chain resilience and regulatory compliance, especially given the complexity of nucleic acid therapeutics manufacturing.

Conclusion
The supply chain for Leqvio encompasses various specialized suppliers across raw materials, formulation, manufacturing, and distribution. The core suppliers are predominantly integrated into Novartis’s global network, supported by strategic partnerships with nucleic acid synthesis firms, lipid providers, and logistics companies. This intricate ecosystem is vital to delivering consistent, high-quality therapeutics to patients worldwide.

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Key Takeaways

• Inclisiran’s supply chain involves sourcing highly specialized raw materials, including phosphoramidites and lipids, from global suppliers such as Thermo Fisher Scientific, Merck, Avanti Polar Lipids, and Lipoid GmbH.
• Contract manufacturing organizations like CordenPharma are crucial in scale-up and production, ensuring regulatory compliance and high-quality API manufacturing.
• The formulation and packaging components are supplied by firms specializing in sterile vials and nanoparticle excipients, ensuring drug stability and delivery efficacy.
• Efficient, temperature-controlled logistics are essential for global distribution, with major wholesalers and cold chain providers integral to supply chain success.
• Continuous collaboration between Novartis and critical suppliers supports the drug’s quality, availability, and compliance across diverse markets.

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FAQs

Q1: Who are the main suppliers of the raw materials used in inclisiran production?
A1: Thermo Fisher Scientific and Merck KGaA supply key nucleotide intermediates, while lipid components are sourced from Avanti Polar Lipids and Lipoid GmbH.

Q2: Does Novartis manufacture inclisiran in-house or rely on external partners?
A2: Novartis primarily collaborates with specialized contract manufacturing organizations like CordenPharma for large-scale API production, ensuring compliance with regulatory standards.

Q3: What logistics are involved in distributing Leqvio globally?
A3: Distribution relies on major pharmaceutical wholesalers, cold chain logistics providers, and regulatory support to ensure stability, timely delivery, and adherence to storage requirements.

Q4: Are there any plans to diversify suppliers for inclisiran raw materials?
A4: While Novartis maintains strategic relationships, industry trends favor diversification to mitigate risks, and alternative suppliers are likely under evaluation or already operational.

Q5: How do regulatory requirements affect the supply chain of Leqvio?
A5: Regulatory standards dictate the manufacturing, testing, and distribution processes, requiring suppliers to maintain strict quality assurance protocols and compliance documentation.

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Sources
[1] Novartis. "Leqvio (inclisiran) Highlights." Novartis Official Website, 2023.
[2] Thermo Fisher Scientific. "Nucleotide and Nucleoside Reagents." Product Catalog, 2022.
[3] CordenPharma. "Nucleic Acid API Manufacturing." Corporate Brochure, 2022.
[4] U.S. Pharmacopeia. "Quality Standards for Pharmaceutical Ingredients," 2023.