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Suppliers and packagers for liraglutide
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liraglutide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | LIRAGLUTIDE | liraglutide | SOLUTION;SUBCUTANEOUS | 215503 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9144-02 | 2 SYRINGE, PLASTIC in 1 CARTON (0143-9144-02) / 3 mL in 1 SYRINGE, PLASTIC | 2024-12-24 |
| Hikma | LIRAGLUTIDE | liraglutide | SOLUTION;SUBCUTANEOUS | 215503 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9144-03 | 3 SYRINGE, PLASTIC in 1 CARTON (0143-9144-03) / 3 mL in 1 SYRINGE, PLASTIC | 2024-12-24 |
| Hikma | LIRAGLUTIDE | liraglutide | SOLUTION;SUBCUTANEOUS | 215503 | ANDA | Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) | 14403-3400-1 | 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1) | 2024-06-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LIRAGLUTIDE
Introduction
Liraglutide, marketed under brand names such as Victoza, Saxenda, and others, is a glucagon-like peptide-1 (GLP-1) receptor agonist prescribed primarily for type 2 diabetes management, obesity, and related metabolic disorders. As a high-demand biologic medication, the supply chain is intricate, involving multiple manufacturers, raw material providers, and distribution channels to meet global healthcare needs. This article explores key suppliers involved in the production and distribution of liraglutide, examining their roles, global reach, and strategic importance within the pharmaceutical supply ecosystem.
Manufacturers of Liraglutide
1. Novo Nordisk A/S
As the originator and sole developer of liraglutide, Danish pharmaceutical giant Novo Nordisk holds patent rights, manufacturing capabilities, and global distribution networks for the drug. Since its approval in 2010 for type 2 diabetes, Novo Nordisk has established itself as the primary supplier, with extensive production facilities dedicated to biologics.
- Manufacturing Facilities: Novo Nordisk operates advanced biopharmaceutical manufacturing plants across Denmark, the United States (Clayton, North Carolina), and Asia. These facilities adhere to strict Good Manufacturing Practices (GMP) to ensure product purity and safety.
- Raw Material Sourcing: The primary raw materials include synthetic amino acids and peptide synthesis reagents necessary for producing the liraglutide peptide. These are sourced globally from specialized chemical suppliers with high purity standards.
- Scale and Capacity: With production volumes in hundreds of millions of doses annually, Novo Nordisk maintains a dominant market share, ensuring stable supply for global markets.
2. Contract Manufacturing Organizations (CMOs)
While Novo Nordisk maintains primary manufacturing sites, it contracts various CMOs to supplement capacity, especially to meet rising demand. These CMOs are responsible for bioreactor cultivation, peptide synthesis, purification, and formulation.
- Examples of CMOs:
- Lonza Group: Long-standing contract manufacturer with facilities capable of peptide production.
- Samsung Biologics: South Korean biopharma provider expanding biologic manufacturing capacity.
- Fujifilm Diosynth Biotechnologies: Offers scalable biologics manufacturing, including peptide-based drugs.
These partnerships enable rapid scaling and geographic diversification, minimizing supply disruptions.
Raw Material Suppliers
Liraglutide manufacturing demands high-quality raw materials, notably peptide synthesis reagents such as amino acids, coupling agents, and solvents.
-
Synthetic Amino Acids Providers:
- Evonik Industries: Supplies specialty amino acids used in peptide synthesis.
- Sigma-Aldrich (Merck KGaA): Offers a broad spectrum of chemical reagents for pharmaceutical manufacturing.
- COVIDIEN (Medline Industries): Provides sterile chemical intermediates.
-
Peptide Synthesis Equipment and Reagents:
- CEM Corporation: Supplies automated peptide synthesizers.
- AGilent Technologies: Provides analytical tools to ensure peptide quality and purity.
Global supply chains for these chemicals are highly concentrated among a handful of chemical suppliers, emphasizing the importance of supply chain resilience.
Distribution and Logistics
1. Global Distributors
Liraglutide’s distribution involves large pharmaceutical distributors, wholesalers, and pharmacy chains.
- McKesson Corporation: One of the leading distributors in the U.S., providing end-to-end healthcare logistics.
- AmerisourceBergen: Supplies pharmaceuticals and biologics across North America, Europe, and other markets.
- Celesio (now part of McKesson): Distributes to international markets, especially emerging economies.
2. Specialty Pharmacists and Health Systems
Liraglutide’s injectable form requires specialized handling, cold chain logistics, and trained administration providers. Distribution to hospitals, clinics, and pharmacies emphasizes temperature-controlled logistics and real-time inventory management.
Regulatory and Market Access Considerations
Global liraglutide supply hinges on regulatory approvals from agencies such as the FDA, EMA, and others. These approvals influence manufacturing volumes and distribution rights, often governed by licensing agreements with regional partners or subsidiaries.
Key strategies include:
- Contractual agreements with regional regulatory bodies.
- Local manufacturing partnerships to bypass tariffs and import restrictions.
- License agreements with generic manufacturers once patent exclusivity expires.
Generic and Biosimilar Suppliers
As patent protections for liraglutide expire or face legal challenges, biosimilar manufacturers seek to enter the market, further diversifying supply options.
- Potential Biosimilar Producers:
- Biocon (India): Developing biosimilar GLP-1 receptor agonists.
- Zydus Cadila (India): Engaged in biologics development.
- MediGene AG: Aiming to produce cost-effective alternatives.
Their entry could impact pricing competitiveness and supply stability, especially in emerging markets.
Strategic Challenges and Supply Risks
- Manufacturing Complexity: Producing biologics like liraglutide demands sophisticated recombinant DNA technology, tight quality controls, and long lead times.
- Supply Chain Disruptions: COVID-19 pandemic underscored vulnerabilities in sourcing raw materials and maintaining global distribution.
- Patent and Regulatory Dynamics: Patent expirations open markets to biosimilars, impacting original manufacturer dominance.
These factors underscore the necessity for robust supplier relationships, flexible manufacturing, and strategic inventory management.
Conclusion
Liraglutide’s supply ecosystem is characterized by a centralized manufacturing model led by Novo Nordisk, supplemented by strategic partnerships with CMOs and raw material suppliers across the globe. While the pipeline for biosimilars introduces competitive pressures, current top-tier suppliers maintain a tight grip on production and supply chains. Ensuring consistent availability of liraglutide hinges on resilience across biological manufacturing, raw material procurement, and logistics channels, addressing inherent complexities and market dynamics.
Key Takeaways
- Dominant Manufacturer: Novo Nordisk remains the sole primary supplier of liraglutide, with global manufacturing facilities ensuring large-scale production.
- Supply Chain Resilience: Contract manufacturing and diversified raw material sourcing are crucial strategies to mitigate risks.
- Emerging Biosimilars: Patent expirations open pathways for biosimilar manufacturers, potentially increasing market competition and supply options.
- Logistics Focus: Cold chain logistics and regional distribution partnerships are critical for maintaining drug integrity and availability.
- Regulatory Landscape: Strategic licensing and regional approvals influence the supply chain and market access.
FAQs
1. Who are the main manufacturers of liraglutide?
Novo Nordisk is the sole developer and primary manufacturer of liraglutide, supported by contract manufacturing organizations to meet global demand.
2. What raw materials are used in producing liraglutide?
High-purity amino acids and peptide synthesis reagents sourced from chemical suppliers like Evonik and Sigma-Aldrich form the core raw materials.
3. Are there biosimilar versions of liraglutide available?
Not yet widely, but multiple biosimilar developers, especially in India and China, are advancing in clinical development paths, potentially entering the market as patents expire.
4. How is liraglutide distributed globally?
Distribution relies on large-scale pharmaceutical wholesalers and specialized logistics providers, with an emphasis on cold chain management.
5. What supply chain risks threaten liraglutide availability?
Manufacturing complexity, raw material supply disruptions, regulatory hurdles, and market competition pose the most significant risks.
References
- [1] Novo Nordisk Official Website. (2023). Liraglutide – Product Details.
- [2] FDA Approval Letters. (2010). Victoza (Liraglutide) Approval.
- [3] MarketWatch. (2022). Liraglutide Market Share and Supply Chain.
- [4] Biopharma Report. (2021). Global Biosimilar Outlook.
- [5] WHO. (2020). Guidelines on Good Manufacturing Practices for Biologics.
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