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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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    16-Jun-2021
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    ABOUT THIS PAGE

    Diclofenac Epolamine Manufacturers

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

    Diclofenac Epolamine Suppliers

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

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

    Diclofenac Epolamine USDMF

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

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

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

    Diclofenac Epolamine KDMF

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

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

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

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

    Diclofenac Epolamine WC

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

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

    Diclofenac Epolamine 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 Diclofenac Epolamine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Diclofenac Epolamine GMP

    Diclofenac Epolamine 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 Diclofenac Epolamine 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 Diclofenac Epolamine GMP manufacturer or Diclofenac Epolamine GMP API supplier for your needs.

    Diclofenac Epolamine CoA

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

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

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