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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	208705	ANDA	Alembic Pharmaceuticals Limited	46708-244-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-30)	2017-05-15
Alembic	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	208705	ANDA	Alembic Pharmaceuticals Limited	46708-244-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-90)	2017-05-15
Alembic	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	208705	ANDA	Alembic Pharmaceuticals Limited	46708-244-91	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-91)	2017-05-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Fenofibric acid is a widely prescribed lipid-lowering agent primarily used to reduce elevated triglycerides and to increase high-density lipoprotein (HDL) cholesterol levels. It is a metabolite of fenofibrate, and its formulation enhances bioavailability while reducing certain gastrointestinal side effects associated with the prodrug. The global demand for fenofibric acid has surged, driven by rising prevalence of dyslipidemia and cardiovascular diseases. This heightened demand has expanded the pharmaceutical supply chain, involving various manufacturers, intermediaries, and raw material suppliers.

This article provides an in-depth overview of the key suppliers involved in the fenofibric acid supply chain, highlighting manufacturer profiles, raw material sources, and the strategic landscape shaping the fenofibric acid market.

Major Pharmaceutical Manufacturers of Fenofibric Acid

1. Zhejiang Omnipharma (Zhejiang, China)

Zhejiang Omnipharma stands as one of the leading manufacturers producing fenofibric acid formulations and active pharmaceutical ingredients (APIs). Their production facilities are compliant with international quality standards, including Good Manufacturing Practices (GMP), enabling them to serve global markets.

Product Range: They produce both fenofibric acid and its formulations for cardiovascular indications.
Market Reach: Export to North America, Europe, and Asia-Pacific regions.
Certifications: GMP, ISO 9001, and clients' regulatory clearances.

2. Zhejiang Jiuzhoutang Pharmaceutical Co., Ltd. (Zhejiang, China)

Specialized in cardiovascular APIs, Zhejiang Jiuzhoutang produces fenofibric acid with a focus on high purity. Their manufacturing processes incorporate advanced synthesis and purification techniques to ensure consistent product quality.

Supply Volume: Significant capacity to meet large-scale demands.
Quality Assurance: Extensive QC protocols aligned with international standards.

3. Medchem Express (United States/China)

As part of the broader synthetic APIs industry, Medchem Express supplies fenofibric acid to pharmaceutical companies for formulation and research purposes.

Focus: High-purity APIs for R&D and commercial use.
Certifications: cGMP and ISO compliant.

4. Other Notable Manufacturers

Jiangsu Hengrui Medicine Co., Ltd. (China): Produces fenofibric acid as part of their portfolio of cardiovascular drugs.
Luye Pharma Group (China): Supplies both APIs and finished formulations targeting global markets.

Raw Material and Intermediate Suppliers

Fenofibric acid synthesis involves multiple chemical precursors and intermediates, with raw material sourcing being critical to maintaining quality and cost-effectiveness.

1. Benzene Derivatives Suppliers

Benzene derivatives, such as 4-chlorobenzophenone, are primary raw materials.

Suppliers: Companies like TCI Chemicals and Sigma-Aldrich supply high-purity benzene derivatives used in fenofibric acid synthesis.

2. Chlorination and Acylation Reagents

Reagents such as thionyl chloride and acyl chlorides are sourced from chemical giants like Merck and Spectrum Chemicals, ensuring high purity and stability.

3. Specialty Intermediates

Certain intermediates require custom synthesis, often supplied by contract manufacturing organizations (CMOs) with expertise in complex organic syntheses.

4. Raw Material Quality and Regulatory Compliance

Suppliers adhering to pharmacopoeia standards (USP, EP, JP) ensure raw materials meet stringent quality controls, crucial for pharmaceutical manufacturing consistency and regulatory approvals.

Key Market Dynamics and Strategic Considerations

Global Manufacturing Trends

China and India dominate the manufacturing landscape owing to cost advantages and expanding API production capacities.
Regulatory compliance (e.g., EMA, FDA) remains a significant barrier and motivation for suppliers to enhance quality standards.

Supply Chain Risks

Raw material shortages: Fluctuations in benzene derivative supply can impact production timelines.
Regulatory scrutiny: Increasing regulations, especially in the US and Europe, necessitate continuous quality upgrades from suppliers.
Tariff and trade policies: Political factors may influence sourcing and pricing dynamics, particularly if geopolitical tensions affect China-based suppliers.

Innovation and Differentiation

Leading suppliers invest in process improvements and standardization to offer high-purity APIs while achieving cost competitiveness. Some are exploring biosynthesis pathways to enhance sustainability and reduce reliance on petrochemical precursors.

Market Outlook and Trends

The fenofibric acid market is projected to grow at a CAGR of approximately 4-6% over the next five years, driven by rising cardiovascular disease prevalence.
Increasingly, manufacturers are securing diversified supplier bases to mitigate geopolitical and supply chain risks.
The shift towards complex, high-purity APIs emphasizes the importance of reliable raw material sourcing and stringent quality control.

Regulatory and Certification Standards

Suppliers aiming to serve global markets must comply with multiple regulatory standards:

Good Manufacturing Practices (GMP)
ISO 9001 Certification
Pharmacopoeial standards (USP, EP, JP)
Environmental and safety regulations

These standards either enable straight-to-market product distribution or facilitate registration with regulatory agencies.

Conclusion

The fenofibric acid supply chain is characterized by a network of specialized manufacturers based predominantly in China and India, supported by high-quality raw material suppliers from global chemical companies. As the demand grows, supply chain resilience, quality assurance, and regulatory compliance become increasingly critical for manufacturers and end-users alike.

Building robust supplier relationships and ensuring adherence to international standards will be pivotal in maintaining market stability and securing competitive advantages in the fenofibric acid pharmaceutical landscape.

Key Takeaways

The primary suppliers of fenofibric acid are predominantly based in China, with expanding contributions from Indian firms.
Raw material sourcing, especially benzene derivatives and reagents, is critical to product quality and regulatory compliance.
Supply chain resilience depends on diversification of suppliers, strict quality control, and adherence to international standards.
Technological innovations in synthesis and purification can enhance product quality and reduce costs.
Cultural shifts towards sustainability and biosynthesis may influence future supplier offerings.

Frequently Asked Questions

1. Who are the leading global manufacturers of fenofibric acid?
Major manufacturers include Zhejiang Omnipharma and Zhejiang Jiuzhoutang Pharmaceutical Co., Ltd. in China, along with Medchem Express and others serving the global market.

2. What are the primary raw materials used in fenofibric acid production?
Key raw materials include benzene derivatives like 4-chlorobenzophenone, acyl chlorides, and chlorination reagents such as thionyl chloride, supplied by major chemical companies.

3. How does regulatory compliance affect fenofibric acid suppliers?
Regulatory standards like GMP, ISO 9001, and pharmacopoeia requirements ensure product consistency, safety, and market access, making compliance vital for global suppliers.

4. Are there risks associated with the supply chain for fenofibric acid?
Yes; risks include raw material shortages, geopolitical tensions, regulations, and quality compliance issues, which can impact production continuity.

5. What trends are shaping the future of fenofibric acid suppliers?
Emphasis on high-purity product offerings, supply chain diversification, adoption of sustainable synthesis methods, and regulatory advancements are shaping the market.

Sources

[1] MarketResearch.com, "Fenofibrate and Fenofibric Acid Market Analysis," 2022.
[2] Global Chemical Suppliers Database, 2023.
[3] U.S. Food and Drug Administration (FDA) – Pharmaceutical Quality Standards, 2022.
[4] Chinese Chemical Industry Reports, 2022.
[5] International Pharmacopoeia, 2023.

Suppliers and packagers for FENOFIBRIC ACID

FENOFIBRIC ACID

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