Suppliers and packagers for generic pharmaceutical drug: FENOFIBRATE

FENOFIBRATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA	Lupin Pharmaceuticals, Inc.	27437-109-06	30 CAPSULE in 1 BOTTLE (27437-109-06)	2009-09-25
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA	Lupin Pharmaceuticals, Inc.	27437-110-06	30 CAPSULE in 1 BOTTLE (27437-110-06)	2009-09-25
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA AUTHORIZED GENERIC	Lupin Pharmaceuticals, Inc.	68180-130-06	30 CAPSULE in 1 BOTTLE (68180-130-06)	2013-02-22

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: FENOFIBRATE

Introduction

Fenofibrate is a lipid-modifying agent primarily prescribed for the management of hypercholesterolemia and hypertriglyceridemia. As a prodrug that activates peroxisome proliferator-activated receptor-alpha (PPAR-α), fenofibrate effectively reduces triglyceride levels and modulates cholesterol profiles. The global demand for fenofibrate has driven a complex supply chain comprising multiple manufacturers, generic suppliers, and contract manufacturing organizations (CMOs). This article explores the key suppliers, their manufacturing capacities, market share, and strategic positioning within the fenofibrate supply ecosystem.

Overview of Fenofibrate Manufacturing and Supply Chain

The manufacturing of fenofibrate involves intricate chemical synthesis processes requiring high-quality raw materials and stringent compliance with Good Manufacturing Practices (GMP). Major pharmaceutical companies hold patents or exclusive marketing rights, while the proliferation of generics has expanded the supply base. Global production is concentrated in regions with established pharmaceutical manufacturing infrastructure, notably India, China, and Europe.

Leading Suppliers in the Fenofibrate Market

1. Teva Pharmaceuticals

Teva Pharmaceuticals, headquartered in Israel, is one of the leading suppliers of generic fenofibrate formulations globally. The company's extensive portfolio encompasses various dosage forms—capsules, tablets, and sustained-release formulations. Teva's manufacturing facilities in India, Europe, and North America comply with international regulatory standards, allowing widespread distribution.

Market position: As a top generic supplier, Teva commands significant market share. Its robust distribution channels and investments in quality assurance bolster its position as a reliable fenofibrate source.

2. Mylan (Now part of Viatris)

Mylan, acquired by Viatris in 2020, has been a prominent fenofibrate producer with a broad generic portfolio. The company’s manufacturing facilities in the US, India, and the Philippines facilitate wide-reaching supply capabilities.

Market position: Viatris maintains a substantial share of the fenofibrate market, leveraging Mylan's existing manufacturing assets and global footprints to meet increasing demand, especially in emerging markets.

3. Sandoz (Novartis Division)

Sandoz, a division of Novartis, specializes in biosimilars and generics, including fenofibrate. Its focus on high-quality manufacturing in Switzerland, India, and Europe ensures compliance with global standards.

Market position: Sandoz’s reputation for quality and strategic regional presence make it a prominent exporter of fenofibrate formulations, especially in Europe and parts of Asia.

4. Dr. Reddy’s Laboratories

An Indian multinational, Dr. Reddy’s manufactures fenofibrate under various brand names and as generic formulations. Its facilities in India and the US enable cost-effective production and supply.

Market position: Dr. Reddy’s is a key player in the Asian and US markets, with a focus on affordability and reliable supply.

5. Zhejiang Huahai Pharmaceutical

A leading Chinese pharmaceutical manufacturer, Zhejiang Huahai produces fenofibrate APIs (Active Pharmaceutical Ingredients) and finished formulations. Its extensive API production capacity supports both domestic and export markets.

Market position: As a major API supplier, Zhejiang Huahai’s active API exports bolster global fenofibrate availability, especially in Asian and emerging markets.

API Suppliers and Contract Manufacturers

The supply of fenofibrate APIs is concentrated among a handful of regional chemical producers:

• Zhejiang Huahai Pharmaceutical (China)
• Aurobindo Pharma (India)
• Sun Pharmaceutical Industries (India)
• Capsugel (a Lonza business) — supplying finished dosage forms and encapsulation solutions

Contract manufacturing organizations (CMOs) also play a vital role by producing fenofibrate formulations for branded and generic markets, offering scalability and regulatory expertise.

Market Dynamics and Regulatory Influences

The supply landscape is influenced by patent expirations, regulatory approvals, and quality standards imposed by agencies such as the FDA, EMA, and PMDA. The expiry of patents in various jurisdictions has spurred a surge in generic fenofibrate manufacturers, diversifying the supply base but also intensifying competitive pressures.

Moreover, recent regulatory scrutinies in China and India—regarding manufacturing quality and API safety—have prompted investments in plant upgrades, affecting supply continuity. For example, Zhejiang Huahai faced recalls due to contamination issues, prompting shifts in supplier reliance (as seen with reformulation and quality assurance measures).

Emerging Suppliers and Future Trends

Emerging suppliers in Southeast Asia seek to expand their market shares through strategic partnerships and capacity enhancements. Additionally, innovation in fenofibrate delivery forms—such as nanoparticle formulations and combination therapies—may influence sourcing strategies for pharmaceutical companies.

The trend toward greater API vertical integration encourages pharmaceutical firms to establish in-house manufacturing or direct procurement agreements, thereby affecting traditional supplier dominance.

Supply Chain Challenges and Considerations

• Regulatory compliance: Ensuring suppliers meet GMP and bioequivalence standards is critical to avoid supply disruptions.
• Raw material sourcing: Dependence on chemical raw materials can introduce variability and geopolitical risks.
• Quality assurance: Continuous monitoring and quality audits are essential to mitigate contamination and substandard products.
• Supply chain resilience: Diversification of suppliers minimizes risks associated with geopolitical tensions, pandemics, and logistical disruptions.

Summary of Key Suppliers

Supplier	Focus Area	Market Share	Geographic Presence	Notable Attributes
Teva Pharmaceuticals	Generics/formulations	Leading	Global	Extensive product portfolio, compliance
Mylan (Viatris)	Generics, APIs	Major	North America, Asia	Wide distribution network
Sandoz	Generics, biosimilars	Significant	Europe, Asia	Focus on quality and regulatory standards
Dr. Reddy’s	Generics, APIs	Substantial	India, US	Cost-effective manufacturing
Zhejiang Huahai	APIs, formulations	Major	China	API production capacity

Conclusion

The fenofibrate supply chain comprises a diversified mix of global pharmaceutical giants, regional manufacturers, and API producers. While leading companies like Teva, Viatris (formerly Mylan), and Sandoz maintain dominant market positions, regional API manufacturers such as Zhejiang Huahai substantially contribute to API supply. The expanding landscape, driven by patent expirations and regulatory shifts, fosters increased competition but also necessitates vigilant quality oversight to prevent supply disruptions. Strategic sourcing, supplier qualification, and regulatory compliance remain pivotal for pharmaceutical companies relying on fenofibrate.

Key Takeaways

• The fenofibrate market is highly fragmented, with several key suppliers driving global availability.
• API manufacturers in China and India dominate API production, supporting both regional and international supply chains.
• Regulatory compliance and quality assurance are central to supplier selection and retention.
• Emerging regional suppliers and innovations could reshape the competitive landscape.
• Diversification of supply sources mitigates risks associated with geopolitical issues and regulatory changes.

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Frequently Asked Questions

1. Who are the primary global suppliers of fenofibrate API?
Zhejiang Huahai Pharmaceuticals (China), Aurobindo Pharma, and Sun Pharmaceutical Industries (India) are prominent API suppliers. They provide raw materials to both branded and generic manufacturers worldwide.

2. How has patent expiry affected the fenofibrate supply chain?
Patent expirations have led to a surge in generic manufacturing, increasing supply diversity but also intensifying competition among suppliers, which can influence pricing and availability.

3. What regulatory standards are critical for fenofibrate suppliers?
Suppliers must comply with GMP, submit bioequivalence data for formulations, and adhere to safety and quality standards mandated by agencies such as the FDA, EMA, and PMDA.

4. Are there risks associated with reliance on Asian API manufacturers?
Yes, potential risks include geopolitical tensions, regulatory scrutiny, supply chain disruptions, and quality concerns. Diversification and rigorous vendor qualification are essential mitigation strategies.

5. What future trends could influence fenofibrate supply?
Innovations in drug delivery, increased API capacity, regional manufacturing growth, and potential supply chain digitalization are expected to shape future fenofibrate sourcing strategies.

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Sources

1. [1] GlobalData Pharma Intelligence Center, "Fenofibrate Market Analysis," 2023.
2. [2] U.S. Food and Drug Administration, "Manufacturing Standards for APIs," 2022.
3. [3] ICIS Chemical Business, "API Production Capacity in China," 2022.
4. [4] IQVIA Institute, "Global Generics Market Trends," 2023.
5. [5] Company websites and annual reports from Teva, Mylan, Sandoz, Dr. Reddy’s, and Zhejiang Huahai.