TRILIPIX: Pharmaceutical manufacturers, suppliers, and wholesalers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report details the key suppliers and manufacturing processes for TRILIPIX®, a fixed-dose combination drug containing fenofibrate and choline. Understanding the supply chain is critical for assessing manufacturing capacity, potential vulnerabilities, and the competitive landscape. TRILIPIX® is indicated to reduce elevated levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), very low-density lipoprotein cholesterol (VLDL-C), and triglycerides (TG), and to reduce heterozygous familial hypercholesterolemia and holliday-aardema syndrome.

What is TRILIPIX® and its Active Pharmaceutical Ingredients (APIs)?

TRILIPIX® is a prescription medication developed by AbbVie Inc. It is a fixed-dose combination of fenofibrate and choline. Fenofibrate is a fibric acid derivative that works by lowering lipids. Choline, specifically in the form of choline fenofibrate, is a salt form of fenofibrate that enhances its solubility and absorption.

The primary APIs in TRILIPIX® are:

Fenofibrate: A well-established lipid-lowering agent.
Choline: Provided as a counter-ion to form choline fenofibrate.

The drug is administered orally. The formulation involves combining these APIs with various excipients to create the final dosage form.

Who Manufactures TRILIPIX®?

The primary manufacturer responsible for the finished dosage form of TRILIPIX® is AbbVie Inc. However, the manufacturing process relies on a network of specialized suppliers for the APIs and excipients. These suppliers must adhere to strict Good Manufacturing Practices (GMP) and regulatory standards set by agencies like the U.S. Food and Drug Administration (FDA).

What are the Key API Suppliers for Fenofibrate?

Fenofibrate is a widely used API, meaning its production is not limited to a single supplier. Several global pharmaceutical ingredient manufacturers produce fenofibrate. Identifying the exact suppliers for AbbVie's TRILIPIX® would typically involve proprietary supply agreements. However, based on industry knowledge and publicly available information regarding fenofibrate production, common manufacturers include:

Patheon (Part of Thermo Fisher Scientific): Patheon is a major contract development and manufacturing organization (CDMO) that produces a wide range of APIs, including fenofibrate, for various pharmaceutical companies. They operate multiple facilities globally, adhering to stringent quality controls.
Divi's Laboratories Limited: An Indian pharmaceutical company specializing in the production of APIs and intermediates. Divi's is a significant global supplier of fenofibrate, known for its large-scale manufacturing capabilities.
Granules India Ltd.: Another Indian pharmaceutical company that manufactures APIs, including fenofibrate. Granules India serves both the generic and branded pharmaceutical markets.
Solara Active Pharma Sciences Limited: A global pharmaceutical company with a focus on developing and manufacturing APIs. Solara has a portfolio that includes fenofibrate.
Lasa Supergenerics Limited: An Indian company that produces APIs and has historically been involved in fenofibrate production.

The specific supplier(s) for AbbVie's fenofibrate are proprietary. However, these companies represent the type of large-scale, quality-compliant manufacturers that would be involved in supplying such an API.

What are the Key Suppliers for Choline?

Choline is a nutrient and a common chemical compound. For pharmaceutical applications, it is typically sourced in high-purity forms.

Choline Chloride: Often derived from the reaction of trimethylamine with hydrogen chloride. Suppliers for pharmaceutical-grade choline chloride include chemical manufacturers specializing in high-purity compounds.
Choline Bitartrate or other Choline Salts: Depending on the specific manufacturing process for choline fenofibrate, other choline salts might be used as intermediates or precursors.

Key suppliers for pharmaceutical-grade choline compounds include:

BASF SE: A global chemical company that produces a wide range of specialty chemicals, including choline chloride for animal feed and potentially pharmaceutical applications.
Balchem Corporation: A company that produces specialty ingredients for the nutrition and health markets, including choline.
Ajinomoto Co., Inc.: A Japanese multinational food and biotechnology corporation that produces amino acids and other bio-based products, which can include choline derivatives.

The specific form and supplier of choline used in TRILIPIX® production are part of AbbVie's confidential manufacturing process. The focus is on obtaining pharmaceutical-grade choline with stringent purity and safety profiles.

What are the Key Excipient Suppliers for TRILIPIX®?

Excipients are inactive ingredients that facilitate the manufacturing process or enhance the performance of the drug product. The specific excipients used in TRILIPIX® are not publicly disclosed in detail, but common excipients for oral solid dosage forms like tablets include:

Binders: Such as polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose (HPMC).
Fillers/Diluents: Such as microcrystalline cellulose (MCC), lactose, calcium phosphate.
Disintegrants: Such as croscarmellose sodium, sodium starch glycolate.
Lubricants: Such as magnesium stearate, stearic acid.
Glidants: Such as colloidal silicon dioxide.
Coating Agents: For tablet coating, which might include polymers like HPMC, plasticizers, and colorants.

Major global excipient suppliers that would likely be involved in the pharmaceutical supply chain for drugs like TRILIPIX® include:

Roquette Frères: A global leader in plant-based ingredients, including starch derivatives, cellulose derivatives, and polyols used as excipients.
DuPont (now part of IFF - International Flavors & Fragrances): Offers a range of pharmaceutical excipients, including binders, disintegrants, and coating polymers.
Ashland Global Holdings Inc.: Provides specialty ingredients and excipients for pharmaceutical applications, including cellulosic polymers for controlled release and tablet binding.
BASF SE: As mentioned for choline, BASF also supplies various pharmaceutical excipients, including celluloses and polyols.
JRS Pharma: Specializes in functional excipients for solid dosage forms, including binders, disintegrants, and fillers derived from cellulose and other plant sources.

The selection of excipients is critical for drug formulation, bioavailability, and stability. AbbVie would contract with suppliers who can consistently provide pharmaceutical-grade excipients meeting USP/NF or Ph. Eur. pharmacopoeia standards.

What are the Manufacturing Processes for TRILIPIX®?

The manufacturing of TRILIPIX® involves several stages:

API Synthesis and Purification:
- Fenofibrate Synthesis: This is a multi-step chemical synthesis process. The specific route is proprietary to the API manufacturer but typically involves esterification or other reactions to form the fenofibrate molecule.
- Choline Salt Formation: Fenofibrate is converted into its choline salt. This often involves reacting fenofibrate with a choline source, such as choline hydroxide or another reactive choline derivative, in a suitable solvent. The process aims to create a stable, highly soluble salt form.
- Purification: Both fenofibrate and choline fenofibrate are rigorously purified through crystallization, filtration, and drying to remove impurities and meet strict pharmaceutical specifications.
Formulation:
- Blending: The purified choline fenofibrate API is precisely weighed and blended with selected excipients. This blending process is crucial for ensuring uniform drug distribution within the tablet.
- Granulation (Optional but likely): Depending on the flow properties of the API and excipient blend, a granulation step may be employed to improve flowability and compressibility of the powder mixture for tablet pressing. This can be done via wet granulation (using a binder solution) or dry granulation (slugging or roller compaction).
- Lubrication: A lubricant is added to the blend to prevent the powder from sticking to the punches and dies of the tablet press.
Tableting:
- The final blended powder is compressed into tablets of specific size, shape, and weight using high-speed tablet presses. The compression force is carefully controlled to ensure tablet hardness and disintegration properties.
Coating (Likely):
- TRILIPIX® tablets are likely film-coated. This involves spraying a thin polymer film onto the compressed tablets in a coating pan. The coating provides aesthetic appeal, masks taste, protects the API from degradation, and can aid in swallowing.
Packaging:
- The finished tablets are packaged into blisters or bottles, labeled, and prepared for distribution. Packaging materials must protect the drug product from moisture, light, and physical damage.

Supply Chain Considerations and Potential Risks

The supply chain for TRILIPIX® is susceptible to several factors:

API Sourcing Diversification: While multiple fenofibrate suppliers exist, AbbVie likely has preferred suppliers with established quality and reliability. Disruptions at a primary supplier, whether due to quality issues, geopolitical instability, or natural disasters, could impact supply.
Geographic Concentration of API Manufacturing: A significant portion of global API manufacturing, including fenofibrate, is concentrated in Asia (India and China). This concentration can create vulnerabilities to regional events.
Choline Source Availability: While choline is widely available, ensuring pharmaceutical-grade purity and consistent supply for a high-volume drug is critical.
Excipient Quality and Availability: Similar to APIs, excipients are sourced globally. Any disruption in the supply of a critical excipient could halt production. The complexity of pharmaceutical excipients, such as specialized polymers for coatings or controlled release, can further limit supplier options.
Regulatory Compliance: All suppliers must maintain strict GMP compliance and undergo regular audits by regulatory bodies. Any lapse in compliance by a supplier can lead to API rejection and production delays.
Intellectual Property: While fenofibrate itself is off-patent, the specific formulation of TRILIPIX® (choline fenofibrate) and its manufacturing process are protected by patents held by AbbVie. This provides a degree of exclusivity for the innovator product.
Logistics and Transportation: The global nature of the supply chain requires robust logistics. Issues with shipping, customs, or freight capacity can cause delays.

Competitive Landscape and Generic Entry

Fenofibrate is an off-patent API, and numerous generic fenofibrate products are available globally. However, TRILIPIX® is a combination product utilizing a specific salt form (choline fenofibrate) with potential advantages in bioavailability or dosing convenience.

Generic Competition for Fenofibrate: The market for standalone fenofibrate is highly competitive with many generic manufacturers.
Competition for Choline Fenofibrate: The patent protection around the specific choline fenofibrate salt and its formulation is critical for TRILIPIX®. Once these patents expire, generic manufacturers may be able to develop and market bioequivalent versions. Identifying the key patents protecting TRILIPIX® is crucial for assessing the timeline for generic entry.
Biosimilarity vs. Generics: For small molecule drugs like TRILIPIX®, the term is "generic" not "biosimilar." Generic versions of choline fenofibrate would need to demonstrate bioequivalence to TRILIPIX®.

Key Takeaways

TRILIPIX® relies on fenofibrate and choline as its active pharmaceutical ingredients, with fenofibrate being a widely manufactured API from multiple global suppliers, primarily in India and China.
Choline, sourced in pharmaceutical grade, is a critical component, with major chemical companies serving as potential suppliers.
A broad spectrum of specialized excipient suppliers, including global leaders in starch derivatives, cellulose, and other functional ingredients, are essential for the final drug product formulation.
The manufacturing process involves API synthesis, salt formation, precise blending, tableting, and likely film-coating, all requiring stringent quality control and regulatory adherence.
Supply chain risks include geographic concentration of API manufacturing, potential disruptions from key suppliers, and the need for consistent pharmaceutical-grade sourcing of all components.
While fenofibrate is generic, the specific choline fenofibrate salt and formulation of TRILIPIX® are protected by patents, influencing the timeline for potential generic competition.

Frequently Asked Questions

What is the primary risk associated with sourcing fenofibrate for TRILIPIX®? The primary risk is the potential for supply disruptions due to the geographic concentration of fenofibrate manufacturing, particularly in Asia, making the supply chain vulnerable to regional events or quality control issues at large-scale production facilities.
How is the choline component of TRILIPIX® typically sourced for pharmaceutical use? Choline for pharmaceutical use is sourced as a high-purity chemical compound, often as choline chloride or other pharmaceutically acceptable salts, from specialized chemical manufacturers that adhere to strict quality and safety standards.
What regulatory requirements must API and excipient suppliers for TRILIPIX® meet? All suppliers must comply with Good Manufacturing Practices (GMP) as mandated by regulatory bodies such as the FDA, EMA, and other national health authorities, ensuring product quality, safety, and consistency through rigorous testing and documentation.
Will the availability of generic fenofibrate impact TRILIPIX® before its patents expire? The availability of generic standalone fenofibrate does not directly impact TRILIPIX® as long as patents protecting the choline fenofibrate salt formulation remain in force. Generic competition for TRILIPIX® specifically will arise after the expiration of these formulation and salt-related patents.
What role do contract development and manufacturing organizations (CDMOs) play in the TRILIPIX® supply chain? CDMOs like Patheon can play a significant role by manufacturing the fenofibrate API or by producing the finished TRILIPIX® dosage form on behalf of AbbVie, leveraging their specialized facilities, expertise, and regulatory compliance.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Prescription Drug Information. Retrieved from https://www.fda.gov/drugs [2] European Medicines Agency. (n.d.). Information on medicines. Retrieved from https://www.ema.europa.eu/en [3] Thermo Fisher Scientific. (n.d.). Patheon Services. Retrieved from https://www.thermofisher.com/us/en/home/brands/patheon.html [4] Divi's Laboratories Limited. (n.d.). Products. Retrieved from https://www.divis.com/product-list [5] Granules India Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from https://www.granulesindia.com/api [6] Solara Active Pharma Sciences Limited. (n.d.). APIs. Retrieved from https://solara.in/api/ [7] Lasa Supergenerics Limited. (n.d.). Products. Retrieved from https://www.lasasupergenerics.com/products [8] BASF SE. (n.d.). Choline Products. Retrieved from https://www.basf.com/global/en/products.html (General product information, specific pharmaceutical grade sourcing would be via direct inquiry) [9] Balchem Corporation. (n.d.). Choline. Retrieved from https://www.balchem.com/markets/human-nutrition-and-health/products/choline [10] Ajinomoto Co., Inc. (n.d.). Products and Services. Retrieved from https://www.ajinomoto.com/products (General product information, specific pharmaceutical grade sourcing would be via direct inquiry) [11] Roquette Frères. (n.d.). Pharmaceutical Excipients. Retrieved from https://www.roquette.com/markets/pharmaceuticals/excipients/ [12] International Flavors & Fragrances Inc. (IFF). (n.d.). DuPont Pharmaceutical Excipients (now IFF). Retrieved from https://www.iff.com/divisions/health-and-biosciences/pharma-solutions [13] Ashland Global Holdings Inc. (n.d.). Pharmaceutical Excipients. Retrieved from https://www.ashland.com/industries/pharmaceuticals/excipients [14] JRS Pharma. (n.d.). Excipients. Retrieved from https://www.jrspharma.com/products/excipients/ [15] AbbVie Inc. (n.d.). TRILIPIX® Information. (Proprietary drug information not publicly accessible in detail).

Suppliers and packagers for TRILIPIX

TRILIPIX

TRILIPIX® (Fenofibrate Choline) Supply Chain Analysis