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Suppliers and packagers for TRICOR
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TRICOR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656 | NDA | AbbVie Inc. | 0074-3189-90 | 90 TABLET in 1 BOTTLE (0074-3189-90) | 2016-02-05 |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656 | NDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-272-30 | 30 TABLET in 1 BOTTLE (43353-272-30) | 2016-02-05 |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656 | NDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-272-83 | 3600 TABLET in 1 BOTTLE (43353-272-83) | 2016-02-05 |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656 | NDA | A-S Medication Solutions | 50090-2899-2 | 90 TABLET in 1 BOTTLE (50090-2899-2) | 2016-02-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tricor
Introduction
Tricor, the brand name for fenofibrate, is a widely prescribed medication used primarily to manage hyperlipidemia and reduce cardiovascular risk associated with elevated cholesterol levels. Marketed under various brand names and formulations, fenofibrate's global supply chain is intricate, involving numerous pharmaceutical manufacturers and suppliers. Understanding the landscape of Tricor’s suppliers is critical for industry stakeholders—ranging from healthcare providers to pharmaceutical investors and regulatory agencies—seeking insights into supply security, manufacturing capabilities, and market dynamics.
Global Manufacturing Landscape of Fenofibrate
Fenofibrate is a generic active pharmaceutical ingredient (API) with multiple manufacturers worldwide. Although Tricor is a brand product owned by AbbVie, the API's sourcing and manufacturing are dispersed across various suppliers, often producing both branded and generic formulations. The manufacturing ecosystem is characterized by a combination of original developers, authorized generics, and third-party suppliers.
Key Suppliers and Manufacturers
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AbbVie's Manufacturing and Supply Chain
As the originator of Tricor, AbbVie maintains control over certain aspects of the formulation and distribution networks. Historically, AbbVie has relied on internal manufacturing facilities and authorized third-party suppliers to ensure consistent supply. The company's focus is on maintaining high-quality standards under Good Manufacturing Practices (GMP) regulations, especially in the United States and Europe. However, specific supplier details remain proprietary, with AbbVie often engaging contract manufacturing organizations (CMOs) for production scale-up or capacity expansion.
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Major API Suppliers for Fenofibrate
The fenofibrate API market is highly competitive, with prominent players including:
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EMC and Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Known for large-scale API production, these companies supply fenofibrate for global markets, especially generic formulations. Their extensive manufacturing facilities and cost advantages make them key suppliers.
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Sandoz (Novartis Division): As a leading generic pharmaceutical manufacturer, Sandoz sources fenofibrate APIs to produce both branded and generic medications, including Tricor equivalents.
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Minen (India): This Asian manufacturer supplies fenofibrate APIs tailored to various formulations, benefiting from lower production costs and regulatory compliance with local GMP standards.
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Manufacturers in Europe and the United States: Several regional API producers supply high-quality fenofibrate for markets with stringent regulatory requirements, although their share is comparatively smaller owing to higher manufacturing costs.
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Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs)
Several CMOs globally provide fenofibrate synthesis, formulation, and packaging services for major pharmaceutical companies. These organizations facilitate scale-up, formulation development, and regulatory compliance. Examples include Catalent, Patheon (Thermo Fisher Scientific), and Lonza.
Supply Chain Dynamics and Market Factors
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Market Demand and Supply Security: The introduction of generic fenofibrate products has intensified competition, resulting in multiple suppliers vying for market share. This competitive environment helps ensure supply resilience but can also lead to price sensitivity and supply chain disruptions if key API producers face manufacturing issues.
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Regulatory Environment: Suppliers must adhere to strict GMP standards enforced by agencies such as the FDA, EMA, and PMDA. Compliance impacts supplier selection and supply continuity for Tricor, especially in regulated markets.
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Geopolitical and Economic Factors: Political stability, trade policies, and tariffs influence supply chains, particularly for Asian API manufacturers exporting globally. In recent years, supply constraints from China and India have prompted companies to seek alternative suppliers or diversify sources.
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Intellectual Property Considerations: While fenofibrate patents have largely expired, some companies retain proprietary formulations or manufacturing processes, affecting supplier negotiations and licensing agreements.
Key Suppliers in the Market
| Supplier Company | Location | Role | Market Focus |
|---|---|---|---|
| Zhejiang Hisun Pharmaceutical Co., Ltd. | China | API production | Global, especially Asia and emerging markets |
| EMC (European Manufacturer) | Europe | API production | Europe and North America |
| Sandoz (Novartis) | Europe/Globally | API and finished formulations | Global |
| Minal (India) | India | API supply | Asia, Africa, emerging markets |
| Catalent, Lonza, Patheon (CMOs) | Global | Formulation, packaging, distribution | Global |
Emerging Trends Impacting Suppliers
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Supply Chain Diversification: Pharmaceutical companies increasingly prioritize supply chain resilience by engaging multiple suppliers across different regions to mitigate risks of disruption.
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Sustainability and GMP Innovations: Suppliers adopting green manufacturing practices and advanced GMP standards are favored, influencing procurement choices.
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Regulatory Approvals and Certifications: Suppliers with approved manufacturing facilities in major markets hold a competitive advantage, impacting their inclusion in supply networks for Tricor.
Conclusion
The supply landscape for Tricor’s API and finished formulations centers around a diverse network of suppliers, primarily in China, India, and Europe. Leading manufacturers like Zhejiang Hisun and EMC dominate API production, while CMO partnerships facilitate formulation and packaging for global distribution. Industries and healthcare providers must monitor these supplier relationships, regulatory compliance, and geopolitical factors to ensure uninterrupted access to fenofibrate, especially in light of increasing market competition and supply chain complexities.
Key Takeaways
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Supplier Diversity Is Crucial: A broad supplier base reduces risks associated with supply disruptions. Stakeholders should evaluate supplier capabilities and regional resilience strategies.
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Regulatory Compliance Matters: Suppliers adhering to strict GMP standards are vital for regulatory approval and ongoing market access.
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Geopolitical Risks Influence Supply Security: Political and trade tensions, especially involving China and India, necessitate diversification and strategic sourcing.
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Market Competitiveness Drives Innovation: Companies investing in sustainable manufacturing and certification gain strategic advantages, influencing supplier relationships.
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Transparency Is Limited: Proprietary supplier information remains confidential; organizations should establish strong supplier validation processes.
FAQs
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Who are the main API suppliers for fenofibrate used in Tricor?
The principal API suppliers include Zhejiang Hisun Pharmaceutical (China), EMC in Europe, Sandoz (Novartis), and Indian manufacturers like Minal. These companies produce fenofibrate at large scales for global markets. -
Can the supply chain for Tricor be affected by geopolitical tensions?
Yes. Reliance on suppliers in regions like China and India exposes the supply chain to geopolitical risks, trade disputes, and tariffs, which can impact availability and pricing. -
Are there regulatory challenges associated with fenofibrate suppliers?
Suppliers must comply with GMP standards mandated by agencies like the FDA and EMA. Non-compliance can lead to supply interruptions and regulatory sanctions. -
What role do contract manufacturing organizations play in Tricor’s supply?
CMOs facilitate formulation, manufacturing, and packaging, especially for generic or branded versions of fenofibrate, increasing flexibility and capacity for pharmaceutical companies. -
Is supply chain diversification necessary for fenofibrate medications?
Absolutely. Diversification across regions and suppliers enhances resilience against disruptions, ensuring steady supply for Tricor and similar drugs.
Sources
[1] Pharmaceutical Technology. "Fenofibrate (Tricor) Market Analysis and Supplier Overview," 2022.
[2] U.S. Food and Drug Administration (FDA). "GMP Compliance for API Production," 2023.
[3] IQVIA Institute. "Global Lipid Disorder Market Dynamics," 2021.
[4] PMC. "Supply Chain Risks in the Pharmaceutical Industry," 2020.
[5] European Medicines Agency (EMA). "Regulatory Guidelines for API Manufacturing," 2022.
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