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    Chemistry

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    Also known as: 149-64-4, N-butylscopolammonium bromide, Hyoscine butylbromide, Buscopan, Scopolan, Buscapine
    Molecular Formula
    C21H30BrNO4
    Molecular Weight
    440.4  g/mol
    InChI Key
    HOZOZZFCZRXYEK-HNHWXVNLSA-M
    FDA UNII
    0GH9JX37C8
    Hyoscine Butyl Bromide
    Antimuscarinic quaternary ammonium derivative of scopolamine used to treat cramps in gastrointestinal, urinary, uterine, and biliary tracts, and to facilitate radiologic visualization of the gastrointestinal tract.
    1 2D Structure

    Hyoscine Butyl Bromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(1S,2S,4R,5R)-9-butyl-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonan-7-yl] (2S)-3-hydroxy-2-phenylpropanoate;bromide
    2.1.2 InChI
    InChI=1S/C21H30NO4.BrH/c1-3-4-10-22(2)17-11-15(12-18(22)20-19(17)26-20)25-21(24)16(13-23)14-8-6-5-7-9-14;/h5-9,15-20,23H,3-4,10-13H2,1-2H3;1H/q+1;/p-1/t15?,16-,17-,18+,19-,20+,22?;/m1./s1
    2.1.3 InChI Key
    HOZOZZFCZRXYEK-HNHWXVNLSA-M
    2.1.4 Canonical SMILES
    CCCC[N+]1(C2CC(CC1C3C2O3)OC(=O)C(CO)C4=CC=CC=C4)C.[Br-]
    2.1.5 Isomeric SMILES
    CCCC[N+]1([C@@H]2CC(C[C@H]1[C@H]3[C@@H]2O3)OC(=O)[C@H](CO)C4=CC=CC=C4)C.[Br-]
    2.2 Other Identifiers
    2.2.1 UNII
    0GH9JX37C8
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Bromide, Butylscopolammonium

    2. Bromide, N-butylscopolammonium

    3. Buscapine

    4. Buscolysin

    5. Buscopan

    6. Butylscopolamine

    7. Butylscopolammonium Bromide

    8. Hyoscinbutylbromide

    9. Hyoscine N Butylbromide

    10. Hyoscine N-butylbromide

    11. N Butylscopolammonium Bromide

    12. N-butylbromide, Hyoscine

    13. N-butylscopolammonium Bromide

    14. Scopolaminebutylbromide

    15. Scopolan

    2.3.2 Depositor-Supplied Synonyms

    1. 149-64-4

    2. N-butylscopolammonium Bromide

    3. Hyoscine Butylbromide

    4. Buscopan

    5. Scopolan

    6. Buscapine

    7. Buscolysin

    8. Scobutil

    9. Sporamin

    10. Amisepan

    11. Buscapina

    12. Butylmin

    13. Donopon

    14. Joscine

    15. Monospan

    16. Scobron

    17. Scobutyl

    18. Sparicon

    19. Tirantil

    20. Buscol

    21. Scobro

    22. Buscolamin

    23. Butylscopolammonium Bromide

    24. Butylscopolamine Bromide

    25. Scopolamine Bromobutylate

    26. Hyoscine-n-butyl Bromide

    27. Buscolysine

    28. Stilbron

    29. Hyoscine Butyl Bromide

    30. N-butylhyoscinium Bromide

    31. Butylhyoscine

    32. Scopolamine Butobromide

    33. N-butylhyoscine Bromide

    34. Scoburen

    35. Stibron

    36. Hyoscin-n-butyl Bromide

    37. Scopolamine Butyl Bromide

    38. Scopolamine N-butylbromide

    39. N-butylscopolamine Bromide

    40. Scopolamine N-butyl Bromide

    41. N-butylscopolaminium Bromide

    42. (-)-n-butylscopolamine Bromide

    43. (-)-scopolamine Butylbromide

    44. Mls000069755

    45. 0gh9jx37c8

    46. (-)-scopolamine N-butyl Bromide

    47. Smr000058795

    48. Dsstox_cid_2718

    49. Dsstox_rid_76697

    50. Dsstox_gsid_22718

    51. Cas-149-64-4

    52. Hyoscine Butobromide

    53. Hyoscin-n-butylbromid

    54. Butylscopolamin

    55. Unii-0gh9jx37c8

    56. Buskolamin

    57. Antipan

    58. Buscogast

    59. Hyocimax

    60. Scopinal

    61. Spasmin

    62. Hybrocare

    63. Butylscopolamine Bromide [jan]

    64. Sr-01000759230

    65. Hyoscin-n-butylbromid [german]

    66. Spasler-p

    67. Hyoscin Butobromide

    68. (1?,2?,4?,5?,7?)-9-butyl-7-[(2s)-3-hydroxy-1-oxo-2-phenylpropoxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide

    69. Einecs 205-744-1

    70. Mfcd00078561

    71. Opera_id_556

    72. Ncgc00163224-01

    73. Scopolamine (butylbromide)

    74. Scopolamine N-n-butylbromide

    75. Hyoscine-n-butyl Bromide Bp

    76. Schembl25291

    77. Mls002153372

    78. Mls006013629

    79. Chembl1256901

    80. Dtxsid1022718

    81. Chebi:32123

    82. Hms2235k20

    83. Hms3714i19

    84. Hms3884j15

    85. Hy-n0340

    86. Tox21_112031

    87. Hyoscine Butylbromide [mart.]

    88. Scopolamine Butylbromide [jan]

    89. Akos016009548

    90. Akos037515799

    91. Hyoscine Butylbromide [who-dd]

    92. Tox21_112031_1

    93. Ccg-208412

    94. Cs-3142

    95. Ncgc00186628-02

    96. 3-oxa-9-azoniatricyclo(3.3.1.02,4)nonane, 9-butyl-7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9-methyl-, Bromide, (7(s)-(1alpha,2beta,4beta,5alpha,7beta))-

    97. Ac-34139

    98. As-78017

    99. N-butylscopolammonium Bromide [mi]

    100. Smr004705104

    101. Hyoscine Butylbromide [ep Monograph]

    102. Butylscopolamine Bromide [green Book]

    103. F17660

    104. A884250

    105. J-008603

    106. Sr-01000759230-3

    107. N-butyl Scopolamine Bromide (n-butyl Hyoscine Bromide)

    108. (-)-scopolamine N-butyl Bromide, >=98% (tlc), Powder

    109. Hyoscine Butylbromide, British Pharmacopoeia (bp) Reference Standard

    110. Hyoscine Butylbromide, European Pharmacopoeia (ep) Reference Standard

    111. (1r,2r,4s,5s,7s)-9-butyl-7-{[(2s)-3-hydroxy-2-phenylpropanoyl]oxy}-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0~2,4~]nonane Bromide

    112. (2r,4s,5s,7s)-9-butyl-7-{[(2s)-3-hydroxy-2-phenylpropanoyl]oxy}-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane Bromide

    113. [(1s,2s,4r,5r)-9-butyl-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonan-7-yl] (2s)-3-hydroxy-2-phenylpropanoate;bromide

    114. 1-alpha-h,5-alpha-h-tropanium, 8-butyl-6-beta,7-beta-epoxy-3-alpha-hydroxy-, Bromide, (-)-tropate

    115. 3-oxa-9-azoniatricyclo(3.3.1.0 Sup(2,4))nonane, 9-butyl-7-((2s)-3-hydroxy-1-oxo-2-phenylpropoxy)-9-methyl-, Bromide (1:1),(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)-

    2.4 Create Date
    2006-06-15
    3 Chemical and Physical Properties
    Molecular Weight 440.4 g/mol
    Molecular Formula C21H30BrNO4
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count8
    Exact Mass439.13582 g/mol
    Monoisotopic Mass439.13582 g/mol
    Topological Polar Surface Area59.1 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity500
    Isotope Atom Count0
    Defined Atom Stereocenter Count5
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Muscarinic Antagonists

    Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

    Parasympatholytics

    Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)

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    06-Jan-2022
    13-Jan-2026
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    Drugs in Development

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    • Deals
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Cara Care Announces Collaboration With Consumer Healthcare Business Unit of Sanofi Germany for Digestive Health

    Details:

    Cara Care has teamed up with the Consumer Healthcare Business Unit of Sanofi Germany to provide Sanofi’s Buscomint® bei Reizdarm drug with Cara Care’s digital companion app for digestive conditions.


    Lead Product(s): Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Sanofi

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration April 22, 2020

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    Cara Care

    Germany
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    Lead Product(s) : Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Sanofi

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Cara Care Announces Collaboration With Consumer Healthcare Business Unit of Sanofi Germany for Dig...

    Details : Cara Care has teamed up with the Consumer Healthcare Business Unit of Sanofi Germany to provide Sanofi’s Buscomint® bei Reizdarm drug with Cara Care’s digital companion app for digestive conditions.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    April 22, 2020

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    Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

    Details:

    Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 05, 2015

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    02

    Boehringer Ingelheim GmbH

    Germany
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    Boehringer Ingelheim GmbH

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    Lead Product(s) : Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

    Details : Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 05, 2015

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    Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers

    Details:

    Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 10, 2014

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    03

    Boehringer Ingelheim GmbH

    Germany
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    Annual COG
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Lead Product(s) : Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Voluntee...

    Details : Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 10, 2014

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    Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestina...

    Details:

    Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Abdominal Pain.


    Lead Product(s): Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 17, 2014

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    04

    Boehringer Ingelheim GmbH

    Germany
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    Annual COG
    Not Confirmed

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    Germany
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    Not Confirmed
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    Lead Product(s) : Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Oc...

    Details : Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Abdominal Pain.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 17, 2014

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    Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort

    Details:

    Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colic.


    Lead Product(s): Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 17, 2014

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    05

    Boehringer Ingelheim GmbH

    Germany
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    Annual COG
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    Germany
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    Lead Product(s) : Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of ...

    Details : Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 17, 2014

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    Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms

    Details:

    Hyoscine N-Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Gastrointestinal Diseases.


    Lead Product(s): Hyoscine Butyl Bromide,Paracetamol

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 01, 2014

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    06

    Boehringer Ingelheim GmbH

    Germany
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    Annual COG
    Not Confirmed

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    Germany
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    Lead Product(s) : Hyoscine Butyl Bromide,Paracetamol

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms

    Details : Hyoscine N-Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Gastrointestinal Diseases.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 01, 2014

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    Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain

    Details:

    Buscopan (Hyoscine Butylbromide) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Intestinal Diseases.


    Lead Product(s): Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area: Gastroenterology Brand Name: Buscopan

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 27, 2013

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    07

    Boehringer Ingelheim GmbH

    Germany
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    Annual COG
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    Germany
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    Lead Product(s) : Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pa...

    Details : Buscopan (Hyoscine Butylbromide) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Intestinal Diseases.

    Product Name : Buscopan

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 27, 2013

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    Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers

    Details:

    Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 28, 2012

    blank

    08

    Boehringer Ingelheim GmbH

    Germany
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    Annual COG
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Lead Product(s) : Hyoscine Butyl Bromide,Inapplicable

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscin...

    Details : Hyoscine Butylbromide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    November 28, 2012

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    Sanofi

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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Hyoscine Butylbromide

    Brand Name : Buscopan Ampoules

    Dosage Form : Solution For Injection

    Dosage Strength : 20MG/ML

    Packaging :

    Approval Date : 2017-08-01

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    Sanofi

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Hyoscine Butylbromide

    Brand Name : Buscopan Ibs Relief

    Dosage Form : Tablet

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2017-08-01

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Hyoscine Butylbromide

    Brand Name : Buscopan Ampoules

    Dosage Form : Solution For Injection

    Dosage Strength : 20MG/ML

    Packaging :

    Approval Date : 2018-12-03

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Hyoscine Butylbromide

    Brand Name : Buscopan Ampoules

    Dosage Form : Solution For Injection

    Dosage Strength : 20mg/ml

    Packaging :

    Approval Date : 2019-08-21

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    Regulatory Info : Cancelled

    Registration Country : Spain

    Metamizol Sodium; Butylscopolamine Bromide

    Brand Name : Buscapina Compositum

    Dosage Form : Coated Tablet

    Dosage Strength : 250MG; 10 MG

    Packaging :

    Approval Date : 01-06-1959

    Application Number : 32174

    Regulatory Info : Cancelled

    Registration Country : Spain

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    Regulatory Info : Ethical

    Registration Country : Canada

    HYOSCINE BUTYLBROMIDE

    Brand Name : BUSCOPAN

    Dosage Form : TABLET

    Dosage Strength : 10MG

    Packaging : 100

    Approval Date :

    Application Number : 363812

    Regulatory Info : Ethical

    Registration Country : Canada

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    Regulatory Info : Prescription

    Registration Country : Canada

    HYOSCINE BUTYLBROMIDE

    Brand Name : BUSCOPAN

    Dosage Form : SOLUTION

    Dosage Strength : 20MG/ML

    Packaging : 10X1ML

    Approval Date :

    Application Number : 363839

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info :

    Registration Country : Australia

    hyoscine butylbromide

    Brand Name : Buscopan

    Dosage Form : injection

    Dosage Strength : 20 mg/mL

    Packaging : 5

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Registration Country : Australia

    hyoscine butylbromide

    Brand Name : Buscopan

    Dosage Form : injection

    Dosage Strength : 20 mg/mL

    Packaging : 5

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Registration Country : Australia

    hyoscine butylbromide

    Brand Name : Buscopan

    Dosage Form : injection

    Dosage Strength : 20 mg/mL

    Packaging : 5

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    ABOUT THIS PAGE

    Looking for 149-64-4 / Hyoscine Butyl Bromide API manufacturers, exporters & distributors?

    Hyoscine Butyl Bromide manufacturers, exporters & distributors 1

    48

    PharmaCompass offers a list of Hyoscine Butyl Bromide 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 Hyoscine Butyl Bromide manufacturer or Hyoscine Butyl Bromide supplier for your needs.

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

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

    API | Excipient name

    Hyoscine Butyl Bromide

    Synonyms

    149-64-4, N-butylscopolammonium bromide, Hyoscine butylbromide, Buscopan, Scopolan, Buscapine

    Cas Number

    149-64-4

    Unique Ingredient Identifier (UNII)

    0GH9JX37C8

    About Hyoscine Butyl Bromide

    Antimuscarinic quaternary ammonium derivative of scopolamine used to treat cramps in gastrointestinal, urinary, uterine, and biliary tracts, and to facilitate radiologic visualization of the gastrointestinal tract.

    Hyoscinbutylbromide Manufacturers

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

    Hyoscinbutylbromide Suppliers

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

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

    Hyoscinbutylbromide JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Hyoscinbutylbromide Drug Master File in Japan (Hyoscinbutylbromide JDMF) empowers Hyoscinbutylbromide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Hyoscinbutylbromide JDMF during the approval evaluation for pharmaceutical products. At the time of Hyoscinbutylbromide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Hyoscinbutylbromide suppliers with JDMF on PharmaCompass.

    Hyoscinbutylbromide KDMF

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

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

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

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

    Hyoscinbutylbromide CEP

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

    A Hyoscinbutylbromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyoscinbutylbromide 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 Hyoscinbutylbromide suppliers with CEP (COS) on PharmaCompass.

    Hyoscinbutylbromide WC

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

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

    Hyoscinbutylbromide 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 Hyoscinbutylbromide as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Hyoscinbutylbromide GMP

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

    Hyoscinbutylbromide CoA

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

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

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