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    Also known as: Flector, Diclofenac hydroxyethylpyrrolidine, Diep, Dhep, Diclofenac epolaminum, Diclofenac-epolamine
    Molecular Formula
    C20H24Cl2N2O3
    Molecular Weight
    411.3  g/mol
    InChI Key
    DCERVXIINVUMKU-UHFFFAOYSA-N
    FDA UNII
    X5F8EKL9ZG
    Diclofenac Epolamine
    1 2D Structure

    Diclofenac Epolamine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[2-(2,6-dichloroanilino)phenyl]acetic acid;2-pyrrolidin-1-ylethanol
    2.1.2 InChI
    InChI=1S/C14H11Cl2NO2.C6H13NO/c15-10-5-3-6-11(16)14(10)17-12-7-2-1-4-9(12)8-13(18)19;8-6-5-7-3-1-2-4-7/h1-7,17H,8H2,(H,18,19);8H,1-6H2
    2.1.3 InChI Key
    DCERVXIINVUMKU-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CCN(C1)CCO.C1=CC=C(C(=C1)CC(=O)O)NC2=C(C=CC=C2Cl)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    X5F8EKL9ZG
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Dhep

    2. Diclofenac 1-(2-hydroxyethyl)pyrrolidinium Salt

    3. Diclofenac Hydroxyethylpyrrolidine

    4. Diclofenac-epolamine

    5. Diclofenac-n-(2-hydroxyethyl) Pyrrolidine

    6. Diep

    7. Flector

    8. N-(2-hydroxyethyl)pyrrolidinium (2-((2,6-dichlorophenyl)amino)phenyl)acetate

    2.3.2 Depositor-Supplied Synonyms

    1. Flector

    2. Diclofenac Hydroxyethylpyrrolidine

    3. Diep

    4. Dhep

    5. Diclofenac Epolaminum

    6. Diclofenac-epolamine

    7. X5f8ekl9zg

    8. 2-[2-(2,6-dichloroanilino)phenyl]acetic Acid;2-pyrrolidin-1-ylethanol

    9. N-(2-hydroxyethyl)pyrrolidinium (2-((2,6-dichlorophenyl)amino)phenyl)acetate

    10. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid, Compd. With 1-pyrrolidineethanol (1:1)

    11. Diclofenac 1-(2-hydroxyethyl)pyrrolidinium Salt

    12. Dhep Plaster

    13. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Compd. With 1-pyrrolidineethanol (1:1)

    14. Chebi:48296

    15. Unii-x5f8ekl9zg

    16. Flector (tn)

    17. Licart

    18. Diclofenac-n-(2-hydroxyethyl) Pyrrolidine

    19. Schembl1006944

    20. Chembl1201180

    21. Dtxsid80152531

    22. Diclofenac Epolamine [vandf]

    23. Diclofenac Epolamine [mart.]

    24. S5737

    25. Diclofenac Epolamine [who-dd]

    26. Diclofenac Hydroxyethylpirrolidine

    27. Diclofenac Epolamine [orange Book]

    28. D07818

    29. 528d502

    30. Diclofenac Acid N-(2-hydroxyetheyl) Pyrrolidine Salt

    31. Q27121125

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 411.3 g/mol
    Molecular Formula C20H24Cl2N2O3
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass410.1163980 g/mol
    Monoisotopic Mass410.1163980 g/mol
    Topological Polar Surface Area72.8 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity363
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameFlector
    PubMed HealthDiclofenac
    Drug ClassesAnalgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
    Drug LabelFlector Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and coveredwith a polypropylene film release liner. The release liner is emoved prior to...
    Active IngredientDiclofenac epolamine
    Dosage FormPatch
    RouteTopical
    Strength1.3%
    Market StatusPrescription
    CompanyInst Biochem

    2 of 2  
    Drug NameFlector
    PubMed HealthDiclofenac
    Drug ClassesAnalgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
    Drug LabelFlector Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and coveredwith a polypropylene film release liner. The release liner is emoved prior to...
    Active IngredientDiclofenac epolamine
    Dosage FormPatch
    RouteTopical
    Strength1.3%
    Market StatusPrescription
    CompanyInst Biochem

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Inflammatory Agents, Non-Steroidal

    Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cyclooxygenase Inhibitors [MoA]; Decreased Prostaglandin Production [PE]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

    API Reference Price

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    24-Feb-2021
    17-Mar-2025
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    ABOUT THIS PAGE

    Looking for 119623-66-4 / Diclofenac Epolamine API manufacturers, exporters & distributors?

    Diclofenac Epolamine manufacturers, exporters & distributors 1

    18

    PharmaCompass offers a list of Diclofenac Epolamine 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 Diclofenac Epolamine manufacturer or Diclofenac Epolamine supplier for your needs.

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

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

    API | Excipient name

    Diclofenac Epolamine

    Synonyms

    Flector, Diclofenac hydroxyethylpyrrolidine, Diep, Dhep, Diclofenac epolaminum, Diclofenac-epolamine

    Cas Number

    119623-66-4

    Unique Ingredient Identifier (UNII)

    X5F8EKL9ZG

    DHEP Manufacturers

    A DHEP manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DHEP, including repackagers and relabelers. The FDA regulates DHEP manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DHEP 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 DHEP manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    DHEP Suppliers

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

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

    DHEP USDMF

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

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

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

    DHEP KDMF

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

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

    After submitting a DHEP 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 DHEP API can apply through the Korea Drug Master File (KDMF).

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

    DHEP WC

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

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

    DHEP 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 DHEP as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for DHEP 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 DHEP 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 DHEP and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DHEP NDC to their finished compounded human drug products, they may choose to do so.

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

    DHEP GMP

    DHEP 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 DHEP 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 DHEP GMP manufacturer or DHEP GMP API supplier for your needs.

    DHEP CoA

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

    DHEP CoA mostly includes findings from lab analyses of a specific batch. For each DHEP 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.

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