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    Chemistry

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    Also known as: 141625-93-6, Dronedarone hcl, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)methanesulfonamide hydrochloride, Dronedarone, hcl, Dronedarone (hydrochloride), Dronedarone hydrochloride [usan]
    Molecular Formula
    C31H45ClN2O5S
    Molecular Weight
    593.2  g/mol
    InChI Key
    DWKVCQXJYURSIQ-UHFFFAOYSA-N
    FDA UNII
    FA36DV299Q
    Dronedarone Hydrochloride
    1 2D Structure

    Dronedarone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C31H44N2O5S.ClH/c1-5-8-12-29-30(27-23-25(32-39(4,35)36)15-18-28(27)38-29)31(34)24-13-16-26(17-14-24)37-22-11-21-33(19-9-6-2)20-10-7-3;/h13-18,23,32H,5-12,19-22H2,1-4H3;1H
    2.1.3 InChI Key
    DWKVCQXJYURSIQ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCC1=C(C2=C(O1)C=CC(=C2)NS(=O)(=O)C)C(=O)C3=CC=C(C=C3)OCCCN(CCCC)CCCC.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    FA36DV299Q
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. 141625-93-6

    2. Dronedarone Hcl

    3. N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)methanesulfonamide Hydrochloride

    4. Dronedarone, Hcl

    5. Dronedarone (hydrochloride)

    6. Dronedarone Hydrochloride [usan]

    7. Sr33598b

    8. Sr33589 Hydrochloride

    9. Dronedarone Hcl (multaq)

    10. Fa36dv299q

    11. N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide;hydrochloride

    12. Sr-33598b

    13. 141625-93-6 (hcl); 141626-36-0 (free Base).

    14. Methanesulfonamide, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-, Monohydrochloride

    15. N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-benzofuran-5-yl)methanesulfonamide Hydrochloride

    16. N-(2-butyl-3-(4-(3-(dibutylamino)proproxy)benzoyl)benzofuran-5-yl) Methanesulfonamide-, Monohydrochloride

    17. N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide Hydrochloride

    18. Smr003500707

    19. Unii-fa36dv299q

    20. Dronedarone Hcl

    21. Mfcd00914940

    22. Multaq (tn)

    23. N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide Monohydrochloride

    24. Dronedarone Hydrocholoride

    25. 4ch-007232

    26. Mls004774028

    27. Mls006011986

    28. Schembl223035

    29. Chembl1201729

    30. Dronedarone Hydrochloride (usp)

    31. Dronedarone Hydrochloride- Bio-x

    32. Dtxsid30161779

    33. Bcp22474

    34. S2114

    35. Dronedarone Hydrochloride [mi]

    36. Akos005145691

    37. Ac-5011

    38. Ccg-270168

    39. Cs-0712

    40. Ks-1260

    41. Dronedarone Hydrochloride [mart.]

    42. Bd164395

    43. Dronedarone Hydrochloride [usp-rs]

    44. Dronedarone Hydrochloride [who-dd]

    45. Hy-75839

    46. N-(2-butyl-3-{4-[3-(dibutylamino)propoxy]benzoyl}-1-benzofuran-5-yl)methanesulfonamide Hydrochloride

    47. Dronedarone Hydrochloride, >=98% (hplc)

    48. D4689

    49. Ft-0667799

    50. Sw219413-1

    51. D03914

    52. Dronedarone Hydrochloride [ep Monograph]

    53. Dronedarone Hydrochloride [orange Book]

    54. Dronedarone Hydrochloride [usp Monograph]

    55. A807785

    56. J-007525

    57. J-520429

    58. Q27277877

    59. Z1550675452

    60. Dronedarone Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    61. Dronedarone Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    62. N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]benzofuran-5-yl]methanesulfonamide Hcl

    63. 2-n-butyl 3-[4-(3-di-n-butylamino-propoxy)benzoyl] 5-methylsulfonamido Benzofuran Hydrochloride

    64. Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-, Hydrochloride (1:1)

    2.4 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 593.2 g/mol
    Molecular Formula C31H45ClN2O5S
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count18
    Exact Mass592.2737714 g/mol
    Monoisotopic Mass592.2737714 g/mol
    Topological Polar Surface Area97.2 Ų
    Heavy Atom Count40
    Formal Charge0
    Complexity800
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2

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    28-Jan-2021
    30-Dec-2024
    KGS
    overview
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    ABOUT THIS PAGE

    Dronedarone Hydrochloride Manufacturers

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

    Dronedarone Hydrochloride Suppliers

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

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

    Dronedarone Hydrochloride USDMF

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

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

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

    Dronedarone Hydrochloride KDMF

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

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

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

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

    Dronedarone Hydrochloride CEP

    A Dronedarone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Dronedarone Hydrochloride Certificate of Suitability (COS). The purpose of a Dronedarone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dronedarone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dronedarone Hydrochloride to their clients by showing that a Dronedarone Hydrochloride CEP has been issued for it. The manufacturer submits a Dronedarone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dronedarone Hydrochloride CEP holder for the record. Additionally, the data presented in the Dronedarone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dronedarone Hydrochloride DMF.

    A Dronedarone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dronedarone Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Dronedarone Hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Dronedarone Hydrochloride WC

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

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

    Dronedarone Hydrochloride 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 Dronedarone Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dronedarone Hydrochloride GMP

    Dronedarone Hydrochloride 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 Dronedarone Hydrochloride 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 Dronedarone Hydrochloride GMP manufacturer or Dronedarone Hydrochloride GMP API supplier for your needs.

    Dronedarone Hydrochloride CoA

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

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

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