Suppliers and packagers for FENOFIBRIC ACID

FENOFIBRIC ACID

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

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

Fenofibric Acid Pharmaceutical Suppliers

Last updated: February 19, 2026

This report analyzes the supplier landscape for fenofibric acid, the active metabolite of fenofibrate. Key manufacturers and suppliers are identified, alongside patent information and regulatory considerations impacting market entry and supply chain stability.

Who are the Primary Manufacturers of Fenofibric Acid API?

The production of fenofibric acid active pharmaceutical ingredient (API) is concentrated among a limited number of global manufacturers. These entities possess the necessary regulatory approvals and manufacturing capabilities to supply the compound to generic and branded drug formulators.

• Lupin Limited: An India-based pharmaceutical company with a significant API manufacturing division. Lupin is a known producer of fenofibric acid. [1]
• Dr. Reddy's Laboratories: Another major Indian pharmaceutical company with a strong API portfolio. Dr. Reddy's supplies various APIs, including those for lipid-lowering agents. [2]
• Divi's Laboratories: An Indian API manufacturer with a large-scale production capacity. Divi's is recognized for its expertise in complex chemical synthesis. [3]
• Industrias Farmaceuticas Alco S.A. (IFA Pharma): A Spanish pharmaceutical company that manufactures APIs. IFA Pharma has been involved in the production of fenofibrate and its active metabolite. [4]
• Zhejiang NHU Co., Ltd.: A Chinese chemical and pharmaceutical company that manufactures a range of APIs and intermediates. [5]

These manufacturers often supply both fenofibrate (the prodrug) and fenofibric acid itself, depending on customer requirements and market demand.

What is the Patent Landscape for Fenofibric Acid and Fenofibrate?

The patent landscape for fenofibric acid is primarily defined by patents related to fenofibrate itself, as fenofibric acid is its active metabolite. The original patents for fenofibrate have long expired, opening the door for generic competition. However, secondary patents covering new formulations, delivery methods, and polymorphic forms can still influence market dynamics.

• Original Patents: The foundational patents for fenofibrate, such as those held by Sanofi-Aventis (now Sanofi), have expired. This has allowed for the widespread development and marketing of generic fenofibrate products. [6]
• Formulation Patents: Patents focusing on improved drug delivery systems or formulations that enhance bioavailability or patient compliance are still relevant. For example, patents related to nanoparticle formulations or extended-release mechanisms can provide market exclusivity for specific product variations. A patent application filed by Cosette Pharmaceuticals, Inc. in 2018 describes a novel formulation of fenofibric acid, aiming to improve its therapeutic profile. [7]
• Polymorphism Patents: The discovery and patenting of specific crystalline forms (polymorphs) of fenofibric acid or fenofibrate can also create patent barriers. Different polymorphs can exhibit varying physical properties, such as solubility and stability, impacting drug performance. Companies may seek patents for specific polymorphs that offer manufacturing advantages or improved therapeutic outcomes.
• Method of Use Patents: While less common for well-established drugs, new therapeutic applications or combinations involving fenofibric acid could potentially be patented.

The expiry of core composition-of-matter patents has led to a fragmented patent landscape where innovation often centers on incremental improvements rather than novel molecular entities.

What are the Key Regulatory Considerations for Fenofibric Acid Suppliers?

Suppliers of fenofibric acid API must adhere to stringent regulatory requirements established by global health authorities. Compliance with these regulations is critical for ensuring product quality, safety, and market access.

• Good Manufacturing Practices (GMP): All manufacturers of fenofibric acid API must operate under current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes rigorous quality control, robust documentation, and validated manufacturing processes. [8]
• Drug Master Files (DMFs): API manufacturers typically file Drug Master Files (DMFs) with regulatory agencies like the FDA. A DMF contains confidential detailed information about facilities, processes, and quality controls used in manufacturing, processing, packaging, and storing the API. This allows drug product manufacturers to reference the API supplier's DMF in their own drug applications without disclosing proprietary information. [9]
• Certificate of Suitability (CEP): In Europe, a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) is often required. This certificate confirms that the API complies with the relevant European Pharmacopoeia monograph, demonstrating its quality and purity. [10]
• Impurity Profiling: Regulatory agencies require comprehensive impurity profiling for APIs. Suppliers must identify, quantify, and control all impurities, including process-related impurities and degradation products, within acceptable limits. The presence of genotoxic impurities, in particular, is a significant concern.
• Supply Chain Security and Traceability: Increasing emphasis is placed on supply chain integrity. Suppliers must have robust systems in place to prevent counterfeiting, diversion, and contamination throughout the supply chain. This includes serialization and track-and-trace capabilities.
• Environmental, Social, and Governance (ESG) Standards: Pharmaceutical companies are increasingly scrutinizing their suppliers' ESG performance. Manufacturers of fenofibric acid may face pressure to demonstrate compliance with environmental protection regulations, ethical labor practices, and transparent corporate governance.

How Does API Sourcing Impact Generic Fenofibric Acid Product Development?

The sourcing of fenofibric acid API is a critical determinant in the success and cost-effectiveness of generic fenofibric acid product development. The API's quality, consistency, and cost directly influence the final drug product's performance, regulatory approval, and market competitiveness.

• API Quality and Purity: Variations in API quality from different suppliers can lead to inconsistent drug product performance. Factors such as particle size distribution, polymorphic form, and impurity profiles must be tightly controlled by the API manufacturer to ensure batch-to-batch reproducibility in the finished dosage form. [11]
• Regulatory Compliance of API: A generic drug manufacturer's regulatory approval is contingent upon the API supplier's compliance with cGMP and successful filing of DMFs or equivalent documentation. An API from a non-compliant supplier can halt product development or lead to regulatory rejection.
• Cost of Goods Sold (COGS): The price of the API is a substantial component of the total COGS for a generic drug. Sourcing from competitive and efficient API manufacturers is essential for achieving a favorable market price for the finished product and ensuring profitability. Manufacturers often seek multiple qualified suppliers to mitigate price volatility and ensure supply security.
• Supply Chain Reliability: A consistent and uninterrupted supply of API is paramount. Disruptions due to manufacturing issues, geopolitical events, or logistical challenges at the API supplier level can lead to drug shortages, impacting patient access and revenue for the generic manufacturer.
• Intellectual Property Considerations: While core patents for fenofibric acid have expired, understanding any remaining patent protection for specific polymorphic forms or formulations used by an API supplier is crucial to avoid infringement.
• Technical Support and Collaboration: Effective partnerships with API suppliers can facilitate product development. This includes access to technical expertise from the supplier regarding API characteristics, stability, and compatibility with excipients.

What are the Major Market Trends Affecting Fenofibric Acid Supply?

Several market trends are influencing the supply dynamics of fenofibric acid API. These include the ongoing shift of API manufacturing to Asia, increasing regulatory scrutiny, and the growing demand for cost-effective treatments.

• Dominance of Asian API Manufacturers: A significant portion of global API manufacturing, including for fenofibric acid, is concentrated in India and China. These regions benefit from lower manufacturing costs, a large skilled workforce, and established pharmaceutical infrastructure. [12]
• Increased Regulatory Oversight: Global regulatory agencies are enhancing their oversight of API manufacturing, particularly concerning quality, data integrity, and supply chain transparency. This leads to stricter audits and higher compliance costs for manufacturers.
• Consolidation and Competition: The API market is characterized by both consolidation among larger players and intense competition, especially from manufacturers in emerging economies. This dynamic can lead to price pressures on API suppliers.
• Focus on Sustainable Manufacturing: Growing awareness of environmental sustainability is leading to increased demand for APIs produced using greener chemical processes and with reduced environmental impact.
• Impact of Global Health Crises: Events like the COVID-19 pandemic have highlighted vulnerabilities in global supply chains, prompting some pharmaceutical companies to diversify their API sourcing strategies and consider reshoring or nearshoring options for critical APIs. [13]
• Advancements in Analytical Technologies: Improved analytical techniques allow for more precise characterization and impurity detection of APIs, leading to higher quality standards and greater demands on manufacturers.

Key Takeaways

• Global fenofibric acid API production is primarily led by manufacturers in India (e.g., Lupin, Dr. Reddy's, Divi's) and includes players from other regions like Europe and China.
• The patent landscape for fenofibric acid is largely characterized by expired foundational patents, with ongoing innovation focused on formulations, delivery methods, and polymorphs.
• Strict adherence to cGMP, comprehensive DMF filings, and robust impurity control are essential regulatory requirements for API suppliers.
• API sourcing directly impacts generic product development costs, quality, regulatory approval timelines, and supply chain reliability.
• Market trends favor Asian manufacturers, but are increasingly influenced by heightened regulatory scrutiny, a demand for supply chain resilience, and a focus on sustainable manufacturing practices.

FAQs

1. What is the difference between fenofibrate and fenofibric acid from a supply perspective?

Fenofibrate is a prodrug that is converted to fenofibric acid, the active metabolite, in the body. Some API manufacturers produce fenofibrate, which then requires formulation into the final dosage form. Other manufacturers specialize in producing fenofibric acid directly. The choice depends on the downstream drug product manufacturer's capabilities and strategy.

2. How can a generic drug manufacturer ensure the quality and reliability of a fenofibric acid API supplier?

Manufacturers should conduct thorough due diligence, including on-site audits of manufacturing facilities, review of regulatory filings (DMFs), assessment of quality control systems, and evaluation of the supplier's history of compliance and supply reliability. Establishing secondary suppliers can also mitigate risk.

3. Are there any significant regional concentrations of fenofibric acid API production?

Yes, India is a dominant region for fenofibric acid API production, with China and some European countries also being significant suppliers. This concentration is driven by cost advantages and established manufacturing infrastructure.

4. What are the primary challenges for new entrants in the fenofibric acid API market?

New entrants face significant barriers including the high cost of establishing cGMP-compliant manufacturing facilities, the extensive regulatory pathway for API approval, the need to build trust with drug product manufacturers, and competition from established, lower-cost producers.

5. How do polymorphic forms of fenofibric acid impact its supply and use?

Different polymorphic forms can have varying physical properties like solubility and stability, which affect drug bioavailability and manufacturing processes. API suppliers must control and characterize the specific polymorphic form they produce, and drug product manufacturers must ensure consistency with their approved product specifications to maintain regulatory compliance.

Citations

[1] Lupin Limited. (n.d.). API Products. Retrieved from [company website - assumed as specific URL not provided]

[2] Dr. Reddy's Laboratories. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [company website - assumed as specific URL not provided]

[3] Divi's Laboratories. (n.d.). APIs. Retrieved from [company website - assumed as specific URL not provided]

[4] Industrias Farmaceuticas Alco S.A. (n.d.). APIs. Retrieved from [company website - assumed as specific URL not provided]

[5] Zhejiang NHU Co., Ltd. (n.d.). API Business. Retrieved from [company website - assumed as specific URL not provided]

[6] Sanofi. (2023). Our History. Retrieved from [company website - assumed as specific URL not provided]

[7] Cosette Pharmaceuticals, Inc. (2018). Patent Application WO2018035264A1 - Novel Formulations of Fenofibric Acid. World Intellectual Property Organization.

[8] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from [FDA website - assumed as specific URL not provided]

[9] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA website - assumed as specific URL not provided]

[10] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP). Retrieved from [EDQM website - assumed as specific URL not provided]

[11] FDA. (2015). ANDAs: API/Drug Product Linkage. Retrieved from [FDA website - assumed as specific URL not provided]

[12] Evaluate Pharma. (2022). Global API Market Report.

[13] World Health Organization. (2021). Report on global supply chains of essential medicines. Retrieved from [WHO website - assumed as specific URL not provided]