Suppliers and packagers for TRILIPIX

TRILIPIX

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	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1554-10	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1554-10)	2016-09-12
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1555-10	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1555-10)	2016-09-12

Suppliers for the Pharmaceutical Drug: TRILIPIX

Last updated: July 27, 2025

Introduction

TRILIPIX, the brand name for fenofibrate, is a widely prescribed lipid-lowering agent used predominantly to manage hypertriglyceridemia and hypercholesterolemia. As a critical component in cardiovascular risk management, the drug commands a significant market presence. Multiple manufacturers and suppliers globally produce and distribute TRILIPIX, operating under stringent regulatory standards to ensure efficacy, quality, and supply continuity. This article provides a comprehensive overview of the key suppliers for TRILIPIX, highlighting their market presence, manufacturing capabilities, regulatory status, and implications for stakeholders.

Understanding TRILIPIX and Its Market

TRILIPIX is a fenofibrate formulation designed to reduce triglycerides, LDL cholesterol, and increase HDL cholesterol, thereby reducing cardiovascular events. Originally developed and commercialized by Abbott Laboratories, the drug has undergone multiple patent and formulation changes, attracting other manufacturers to enter the market via generic and biosimilar pathways. Its active pharmaceutical ingredient (API), fenofibrate, is synthesized globally, with pharmaceutical companies producing both the API and finished dosage forms.

The drug's complex manufacturing process, regulatory requirements, and patent landscape influence supplier diversity. Primary suppliers are classified into two categories:

• API manufacturers: responsible for producing fenofibrate active ingredients.
• Finished dosage form producers: responsible for formulating the API into capsules, tablets, or other delivery forms like TRILIPIX.

Leading Suppliers of TRILIPIX and Fenofibrate API

1. Abbott Laboratories (AbbVie Inc.)

• Market Role: Original patent holder and primary supplier of TRILIPIX.
• Manufacturing Capabilities: Abbott has proprietary manufacturing facilities dedicated to fenofibrate and its formulations, ensuring high quality and supply stability.
• Regulatory Status: TRILIPIX, under Abbott, maintains full compliance with FDA, EMA, and other global regulatory agencies.
• Market Dynamics: Abbott’s patent exclusivity provided a monopoly for initial years. Post-expiry, other manufacturers entered the market, but Abbott continues to be a trusted supplier for the branded product.

2. Mylan (now part of Viatris)

• Market Role: One of the leading generic fenofibrate manufacturers after patent expiry.
• Manufacturing Capabilities: Mylan produces fenofibrate API and finished formulations at multiple sites globally.
• Regulatory Status: Mylan’s fenofibrate products are approved by major drug authorities, including FDA and EMA, and are widely distributed in North America, Europe, and Asia.
• Supply Contribution: Mylan supplies both generic fenofibrate tablets and formulations similar to TRILIPIX, often at lower price points.

3. Teva Pharmaceutical Industries

• Market Role: Major producer of fenofibrate generics.
• Manufacturing Capabilities: Teva operates manufacturing plants in Israel, North America, and Europe, producing fenofibrate API and formulations.
• Regulatory Status: Teva’s fenofibrate products meet strict regulatory standards and are key suppliers across different markets.
• Market share: Significant presence in Europe and North America for fenofibrate generics.

4. Lupin Limited

• Market Role: Leading Indian pharmaceutical company producing fenofibrate API.
• Manufacturing Capabilities: Lupin has robust API manufacturing facilities approved by global regulators.
• Regulatory Status: Its fenofibrate API is approved by US FDA, EMA, and other agencies, facilitating export to developed markets.
• Market Focus: Mainly supplies API to generic drug producers and formulations targeting Asian, African, and Latin American markets.

5. Zydus Cadila

• Market Role: Indian pharmaceutical innovator manufacturing fenofibrate API.
• Capabilities: The company has FDA-approved API facilities and supplies fenofibrate API for both generic and branded formulations.
• Regulatory Status: Approved by global authorities, Zydus supplies API for various formulations, including those analogous to TRILIPIX.

Additional Suppliers and Market Dynamics

Beyond the key players, several emerging manufacturers and regional suppliers contribute to the fenofibrate supply chain. The global fenofibrate API market is characterized by intense competition, with Chinese pharmaceutical companies playing a significant role owing to their large-scale manufacturing capacity and cost advantages.

Some notable regional suppliers include:

• Hetero Labs (India): Produces fenofibrate API and formulations with an expanding export footprint.
• Shenzhen Longwei Technology (China): A growing API producer offering competitive fenofibrate ingredients.

The market has shifted from monopoly-based to highly competitive, with various generic manufacturers securing supply agreements with pharmaceutical companies intending to commercialize TRILIPIX-like formulations.

Regulatory and Quality Considerations

Suppliers must comply with Good Manufacturing Practices (GMP) mandated by agencies such as the FDA, EMA, and others. The quality of API impacts the safety, efficacy, and regulatory approval process for finished products. Notably:

• API Approval: Suppliers like Lupin, Zydus, and Hetero have received approvals for fenofibrate API used in formulations marketed globally.
• Supply Chain Risks: Dependency on regional suppliers, geopolitical factors, and regulatory compliance pose risks to uninterrupted supply.
• Quality Standards: Adherence to pharmacopoeial standards (USP, EP, IP) is critical for global acceptance.

Implications for Pharmaceutical Stakeholders

Pharmaceutical companies seeking to produce TRILIPIX or generic fenofibrate formulations must vet suppliers for:

• Regulatory approval status in target markets.
• Manufacturing capacity and ability to meet demand.
• Quality compliance with GMP standards.
• Supply stability amid geopolitical and economic uncertainties.

End-users and healthcare providers benefit from a diversified supplier landscape, which enhances supply security and potential price competition.

Conclusion

The supply landscape for TRILIPIX involves a mix of original patent holders and a robust network of generic API and formulation manufacturers. Key suppliers such as Abbott, Mylan, Teva, Lupin, and Zydus dominate the global fenofibrate market, supported by emerging regional players. Maintaining stringent regulatory compliance and supply chain agility remains vital for stakeholders to ensure consistent drug availability. As patent expirations continue to proliferate the generic market landscape, partnerships and procurement strategies must adapt accordingly.

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Key Takeaways

• Abbott remains a primary supplier of the original branded TRILIPIX, with regulatory compliance and proprietary manufacturing advantages.
• Generic fenofibrate manufacturers like Mylan and Teva have significantly expanded the supply chain post-patent expiry.
• Indian companies such as Lupin and Zydus are prominent API suppliers, serving international markets with cost-effective production.
• Ensuring regulatory approval and GMP compliance is critical when selecting suppliers for high-quality fenofibrate API.
• Diversification of suppliers mitigates supply risks, especially amid regional geopolitical and supply chain uncertainties.

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FAQs

1. Who are the main suppliers of TRILIPIX?
The main suppliers include Abbott Laboratories (original manufacturer), and generic producers like Mylan, Teva, Lupin, and Zydus, among others, across the globe.

2. How has patent expiry impacted TRILIPIX supply?
Post-patent expiration, market entry by generic manufacturers like Mylan and Teva has led to increased competition, lower prices, and a diversified supply chain.

3. Are there regional differences in fenofibrate suppliers?
Yes. Indian and Chinese manufacturers predominantly supply fenofibrate API for emerging markets, while North American and European markets rely heavily on European and US-approved suppliers.

4. What regulatory considerations are essential for fenofibrate suppliers?
Suppliers must comply with GMP standards and obtain approvals from agencies like the FDA and EMA, ensuring API quality and regulatory acceptance of finished drugs.

5. How can stakeholders ensure supply chain stability for TRILIPIX?
By diversifying suppliers, establishing long-term supply agreements, and prioritizing API manufacturers with proven regulatory compliance and manufacturing capacity.

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References

1. [1] US Food and Drug Administration (FDA). Approved Drug Products.
2. [2] European Medicines Agency (EMA). List of approved products.
3. [3] Market research reports on fenofibrate API and formulations.
4. [4] Company disclosures and annual reports of Abbott, Mylan, Teva, Lupin, and Zydus.
5. [5] Industry analyses on the global fenofibrate market.

Note: This overview reflects the most current publicly available and industry-specific data as of 2023.