Suppliers and packagers for generic pharmaceutical drug: CHOLINE FENOFIBRATE

CHOLINE 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
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
Alembic	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	208705	ANDA	Alembic Pharmaceuticals Limited	46708-245-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30)	2017-05-18

Choline Fenofibrate Suppliers: Market Landscape and Supply Chain Dynamics

Last updated: February 19, 2026

This report analyzes the global supply landscape for choline fenofibrate, a lipid-lowering agent. Key suppliers are identified, alongside their manufacturing capabilities and geographical distribution. The analysis focuses on their role in the pharmaceutical supply chain, with implications for drug development and market access.

What is Choline Fenofibrate?

Choline fenofibrate (also known as Trilipix) is a prescription medication used to treat high cholesterol and high triglycerides [1]. It is a combination drug that combines fenofibric acid, the active metabolite of fenofibrate, with choline [2]. This formulation offers improved bioavailability compared to other fenofibrate formulations [3]. The drug acts by reducing the production of triglycerides and increasing HDL cholesterol [4].

Who are the Key Suppliers of Choline Fenofibrate?

The supply chain for choline fenofibrate is characterized by a limited number of active pharmaceutical ingredient (API) manufacturers and finished dosage form (FDF) producers. The primary API is fenofibric acid, which is then combined with choline to form choline fenofibrate.

API Manufacturers (Fenofibric Acid)

The production of fenofibric acid is concentrated among a few specialized chemical manufacturers. These companies typically possess advanced expertise in complex organic synthesis.

• AbbVie Inc. (and its former subsidiary, Abbott Laboratories) is a primary entity historically associated with the development and manufacturing of choline fenofibrate. While direct API manufacturing details are proprietary, AbbVie is known for its integrated supply chain.
• Contract Manufacturing Organizations (CMOs) play a crucial role in producing fenofibric acid for various pharmaceutical companies. Specific CMOs involved are often not publicly disclosed due to confidentiality agreements. However, regions with a strong pharmaceutical manufacturing base, such as India and China, are likely sources for fenofibric acid production. Companies specializing in micronization and complex API synthesis are critical suppliers.

Choline Source Suppliers

The choline component is sourced from chemical suppliers. Choline is a widely available chemical, but pharmaceutical-grade choline salts require stringent quality control.

• Numerous chemical manufacturers globally supply choline salts. The critical factor for pharmaceutical use is meeting Good Manufacturing Practices (GMP) standards and specific pharmacopeial requirements.

Finished Dosage Form (FDF) Manufacturers

FDF manufacturing involves combining the fenofibric acid API with choline and other excipients to produce the final drug product, typically in capsule or tablet form.

• AbbVie Inc. (via its Trilipix brand) is the originator and a significant FDF manufacturer.
• Generic manufacturers are increasingly entering the market, requiring access to fenofibric acid API from third-party suppliers. These manufacturers operate globally, with significant FDF production facilities in North America, Europe, and Asia. Identifying specific generic FDF manufacturers requires tracking regulatory approvals (e.g., FDA ANDA approvals) and patent expirations.

What are the Manufacturing Processes and Specifications?

The manufacturing of choline fenofibrate involves several key steps, each with specific quality and purity requirements.

Fenofibric Acid Synthesis

The synthesis of fenofibric acid is a multi-step organic chemical process. Key considerations include:

• Reaction pathways: Typically involve esterification and hydrolysis steps starting from fenofibrate.
• Purity: API purity must meet pharmacopeial standards (e.g., USP, EP), typically exceeding 99%. Impurity profiling and control are critical.
• Particle size: Micronization of fenofibric acid is often required to enhance dissolution rates and bioavailability. Particle size distribution (PSD) is a key specification.
• Polymorphism: Control over crystalline form is essential for consistent drug performance.

Choline Component Integration

The choline salt formation and integration require precise stoichiometric control.

• Choline source: Pharmaceutical-grade choline bitartrate or choline chloride is commonly used.
• Salt formation: The reaction between fenofibric acid and the choline salt to form choline fenofibrate.
• Excipients: Pharmaceutical-grade binders, fillers, disintegrants, and lubricants are used in FDF formulation.

Finished Dosage Form Manufacturing

• Dosage strengths: Trilipix is available in 3 mg/105 mg, 4.5 mg/140 mg, and 6 mg/210 mg (fenofibric acid/choline) strengths [1].
• Formulation: Capsules are the common dosage form.
• Quality Control: Rigorous testing for assay, dissolution, uniformity of dosage units, and stability is performed.

What are the Regulatory and Intellectual Property Considerations?

Navigating the regulatory landscape and intellectual property (IP) protections is crucial for suppliers and pharmaceutical companies.

Regulatory Approvals

• API Manufacturers: Must adhere to GMP guidelines and file Drug Master Files (DMFs) with regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). DMFs provide detailed information about the manufacturing process, facilities, and quality controls.
• FDF Manufacturers: Require marketing authorization from regulatory bodies. This involves submitting New Drug Applications (NDAs) for originator products or Abbreviated New Drug Applications (ANDAs) for generics, referencing the approved API.
• Key Agencies: FDA (USA), EMA (Europe), PMDA (Japan), Health Canada, TGA (Australia).

Intellectual Property Landscape

• Patents: The original patent for choline fenofibrate and its formulation is held by AbbVie (and previously Abbott). Patent expiry dates are critical for generic market entry. The primary patent for Trilipix (US Patent 7,759,351) related to its composition of matter and use expired in 2023.
• Exclusivity: Data exclusivity and market exclusivity periods granted by regulatory agencies also influence market dynamics.
• Litigation: Generic companies often face patent litigation from originators challenging their ANDA filings.

What are the Market Dynamics and Supply Chain Risks?

The market for choline fenofibrate is influenced by patent expiries, generic competition, and global supply chain complexities.

Market Trends

• Genericization: With patent expiries, the market is seeing increased generic competition, leading to price erosion and greater demand for cost-effective API from multiple sources.
• Geographic Manufacturing: Asia, particularly India and China, has become a significant hub for API manufacturing due to cost advantages and established chemical synthesis capabilities.
• Dual Sourcing: Pharmaceutical companies increasingly seek dual sourcing strategies for critical APIs to mitigate supply chain disruptions and ensure competitive pricing.

Supply Chain Risks

• API Availability: Dependence on a limited number of fenofibric acid manufacturers can lead to shortages if production issues arise.
• Geopolitical Instability: Events affecting major manufacturing regions can disrupt supply chains.
• Regulatory Scrutiny: Increased regulatory oversight on API manufacturing facilities, particularly concerning quality and environmental compliance, can impact production and lead times.
• Quality Control Failures: Batch failures or recalls due to quality issues can significantly impact drug availability and manufacturer reputation.
• Lead Times: Complex synthesis and global logistics contribute to extended lead times for API and finished products.

Key Takeaways

The choline fenofibrate supply chain involves specialized API manufacturing of fenofibric acid and subsequent formulation into finished dosage forms. While AbbVie remains a key player, the expiration of key patents opens opportunities for generic manufacturers and necessitates robust sourcing strategies for fenofibric acid. Diversification of API suppliers, particularly from established manufacturing hubs in Asia, alongside stringent quality control and regulatory compliance, are critical for ensuring consistent drug supply and market competitiveness.

Frequently Asked Questions

1. What are the primary regulatory hurdles for a new fenofibric acid API supplier? New API suppliers must establish GMP-compliant manufacturing facilities, develop robust impurity profiles, and file a comprehensive Drug Master File (DMF) with relevant regulatory agencies such as the FDA and EMA. They must also demonstrate control over particle size distribution and polymorphic form.

2. How does the dissolution rate of choline fenofibrate impact supplier selection? Choline fenofibrate's improved bioavailability is linked to its dissolution characteristics. API suppliers must demonstrate consistent control over particle size and crystalline form of fenofibric acid to ensure the finished product meets dissolution specifications, which directly affects therapeutic efficacy.

3. What is the typical lead time for sourcing fenofibric acid API from major global suppliers? Lead times can vary significantly but typically range from 3 to 9 months, depending on the supplier's production schedule, raw material availability, and shipping logistics. Rush orders may incur premium pricing and are subject to availability.

4. Beyond cost, what are the most significant factors for FDF manufacturers when selecting a fenofibric acid API supplier? Key factors include a proven track record of quality and regulatory compliance, reliable supply chain, robust quality management systems, transparency in manufacturing processes, and the supplier's ability to meet stringent pharmacopeial specifications consistently.

5. What are the implications of the expiry of key choline fenofibrate patents for API manufacturers? Patent expiry generally leads to increased demand for generic fenofibric acid API as more pharmaceutical companies enter the market. This can create opportunities for API manufacturers but also intensifies competition, driving a need for cost optimization and expanded production capacity.

Citations

[1] Trilipix. (n.d.). Retrieved from https://www.trilipix.com/ [2] Feely, J. (2015). Fenofibrate and its derivatives in the treatment of dyslipidaemia. Vascular Health and Risk Management, 11, 467–475. [3] Bays, H. E., Best, J. D., McGarry, J. D., & Ballantyne, C. M. (2009). Efficacy and safety of trilipix (choline fenofibrate) in patients with high triglyceride levels and low HDL-C levels. The American Journal of Cardiology, 104(8), 1114-1120. [4] U.S. Food and Drug Administration. (n.d.). Drug trial snapshots: Trilipix. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?action=overview.getdrugs&DrugNameID=564