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    Also known as: 856676-23-8, Trilipix, Unii-4bmh7izt98, Abt-335, 2-hydroxy-n,n,n-trimethylethanaminium 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate, Fibricor
    Molecular Formula
    C22H28ClNO5
    Molecular Weight
    421.9  g/mol
    InChI Key
    JWAZHODZSADEHB-UHFFFAOYSA-M
    FDA UNII
    4BMH7IZT98
    Choline Fenofibrate
    Choline Fenofibrate is a choline formulation of fenofibrate, a synthetic phenoxy-isobutyric acid derivate and prodrug with antihyperlipidemic activity.
    1 2D Structure

    Choline Fenofibrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate;2-hydroxyethyl(trimethyl)azanium
    2.1.2 InChI
    InChI=1S/C17H15ClO4.C5H14NO/c1-17(2,16(20)21)22-14-9-5-12(6-10-14)15(19)11-3-7-13(18)8-4-11;1-6(2,3)4-5-7/h3-10H,1-2H3,(H,20,21);7H,4-5H2,1-3H3/q;+1/p-1
    2.1.3 InChI Key
    JWAZHODZSADEHB-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    CC(C)(C(=O)[O-])OC1=CC=C(C=C1)C(=O)C2=CC=C(C=C2)Cl.C[N+](C)(C)CCO
    2.2 Other Identifiers
    2.2.1 UNII
    4BMH7IZT98
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic Acid

    2. Abt 335

    3. Abt-335

    4. Abt335

    2.3.2 Depositor-Supplied Synonyms

    1. 856676-23-8

    2. Trilipix

    3. Unii-4bmh7izt98

    4. Abt-335

    5. 2-hydroxy-n,n,n-trimethylethanaminium 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate

    6. Fibricor

    7. Fenofibric Acid Choline Salt

    8. 4bmh7izt98

    9. Abt 335

    10. 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate;2-hydroxyethyl(trimethyl)azanium

    11. 2-hydroxy-n,n,n-trimethylethanaminium 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate

    12. Ethanaminium, 2-hydroxy-n,n,n-trimethyl-, Salt With 2-(4-(4- Chlorobenzoyl)phenoxy)-2-methylpropanoic Acid (1:1)

    13. Fenofibrate De Choline

    14. Choline Fenofibrate [usan]

    15. Choline Fenofibrate [usan:inn]

    16. Choline Fenofibrate (abt-335)

    17. Hip0901

    18. Trilipix (tn)

    19. Choline Fenofibrate;abt-335

    20. Chembl1201745

    21. Choline Fenofibrate (usan/inn)

    22. Choline Fenofibrate [inn]

    23. Dtxsid50234939

    24. Bcp28592

    25. Choline Fenofibrate [mart.]

    26. Choline Fenofibrate [usp-rs]

    27. Choline Fenofibrate [who-dd]

    28. Mfcd18382233

    29. Akos016010592

    30. Cs-0893

    31. 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate,2-hydroxyethyl(trimethyl)azanium

    32. 2-hydroxy-n,n,n-trimethylethanaminium2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate

    33. Choline Fenofibrate [orange Book]

    34. As-10210

    35. Fenofibric Acid Choline Salt [mi]

    36. Hy-14739

    37. Ft-0665026

    38. D08890

    39. D70702

    40. A863484

    41. Q27259379

    42. 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic Acid Choline Salt

    43. 2-hydroxy-n,n,n-trimethylethan-1-aminium 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate

    44. 2-hydroxy-n,n,n-trimethylethanaminium 2-(-(4-chlorobenzoyl)phenoxy)-2- Methylpropanoate

    45. 2-hydroxy-n,n,n-trimethylethanaminium 2-(4-(4-chlorobenzoyl)phenoxy)-2- Methylpropanoate

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 421.9 g/mol
    Molecular Formula C22H28ClNO5
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass421.1656007 g/mol
    Monoisotopic Mass421.1656007 g/mol
    Topological Polar Surface Area86.7 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity446
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 ATC Code

    C - Cardiovascular system

    C10 - Lipid modifying agents

    C10A - Lipid modifying agents, plain

    C10AB - Fibrates

    C10AB11 - Choline fenofibrate

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    24-Jan-2022
    17-Jun-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 1...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 135MG FENOFIBRIC ACID

    USFDA APPLICATION NUMBER - 22224

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 4...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 45MG FENOFIBRIC ACID

    USFDA APPLICATION NUMBER - 22224

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    ABOUT THIS PAGE

    Looking for 856676-23-8 / Choline Fenofibrate API manufacturers, exporters & distributors?

    Choline Fenofibrate manufacturers, exporters & distributors 1

    26

    PharmaCompass offers a list of Choline Fenofibrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Choline Fenofibrate manufacturer or Choline Fenofibrate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Choline Fenofibrate manufacturer or Choline Fenofibrate supplier.

    PharmaCompass also assists you with knowing the Choline Fenofibrate API Price utilized in the formulation of products. Choline Fenofibrate API Price is not always fixed or binding as the Choline Fenofibrate Price is obtained through a variety of data sources. The Choline Fenofibrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Choline Fenofibrate

    Synonyms

    856676-23-8, Trilipix, Unii-4bmh7izt98, Abt-335, 2-hydroxy-n,n,n-trimethylethanaminium 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate, Fibricor

    Cas Number

    856676-23-8

    Unique Ingredient Identifier (UNII)

    4BMH7IZT98

    About Choline Fenofibrate

    Choline Fenofibrate is a choline formulation of fenofibrate, a synthetic phenoxy-isobutyric acid derivate and prodrug with antihyperlipidemic activity.

    TRILIPIX Manufacturers

    A TRILIPIX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRILIPIX, including repackagers and relabelers. The FDA regulates TRILIPIX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRILIPIX API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of TRILIPIX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    TRILIPIX Suppliers

    A TRILIPIX supplier is an individual or a company that provides TRILIPIX active pharmaceutical ingredient (API) or TRILIPIX finished formulations upon request. The TRILIPIX suppliers may include TRILIPIX API manufacturers, exporters, distributors and traders.

    click here to find a list of TRILIPIX suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    TRILIPIX USDMF

    A TRILIPIX DMF (Drug Master File) is a document detailing the whole manufacturing process of TRILIPIX active pharmaceutical ingredient (API) in detail. Different forms of TRILIPIX DMFs exist exist since differing nations have different regulations, such as TRILIPIX USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A TRILIPIX DMF submitted to regulatory agencies in the US is known as a USDMF. TRILIPIX USDMF includes data on TRILIPIX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRILIPIX USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of TRILIPIX suppliers with USDMF on PharmaCompass.

    TRILIPIX KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a TRILIPIX Drug Master File in Korea (TRILIPIX KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TRILIPIX. The MFDS reviews the TRILIPIX KDMF as part of the drug registration process and uses the information provided in the TRILIPIX KDMF to evaluate the safety and efficacy of the drug.

    After submitting a TRILIPIX KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their TRILIPIX API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of TRILIPIX suppliers with KDMF on PharmaCompass.

    TRILIPIX WC

    A TRILIPIX written confirmation (TRILIPIX WC) is an official document issued by a regulatory agency to a TRILIPIX manufacturer, verifying that the manufacturing facility of a TRILIPIX active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TRILIPIX APIs or TRILIPIX finished pharmaceutical products to another nation, regulatory agencies frequently require a TRILIPIX WC (written confirmation) as part of the regulatory process.

    click here to find a list of TRILIPIX suppliers with Written Confirmation (WC) on PharmaCompass.

    TRILIPIX NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing TRILIPIX as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for TRILIPIX API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture TRILIPIX as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain TRILIPIX and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRILIPIX NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of TRILIPIX suppliers with NDC on PharmaCompass.

    TRILIPIX GMP

    TRILIPIX Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of TRILIPIX GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right TRILIPIX GMP manufacturer or TRILIPIX GMP API supplier for your needs.

    TRILIPIX CoA

    A TRILIPIX CoA (Certificate of Analysis) is a formal document that attests to TRILIPIX's compliance with TRILIPIX specifications and serves as a tool for batch-level quality control.

    TRILIPIX CoA mostly includes findings from lab analyses of a specific batch. For each TRILIPIX CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    TRILIPIX may be tested according to a variety of international standards, such as European Pharmacopoeia (TRILIPIX EP), TRILIPIX JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRILIPIX USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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