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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.)


API Reference Price

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LTD.","customerCountry":"HONG KONG","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"1300","totalValueFC":"23042.6","currency":"USD","unitRateINR":107566,"date":"05-Oct-2024","totalValueINR":"1936188","totalValueInUsd":"23042.6","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"4599504","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"HONG KONG","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8, BENTINCK STREET, KOLKATA (W.B.)","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728585000,"product":"HYOSCINE BUTYL BROMIDE PH.EUR (HYOSCINEN-BUTYL BROMIDE BP\/PH.EUR)(SCOPOLAMINE BASE PH.EUR) WE INTEND TO CLAIM BENEFITS","address":"706 SWAPNALOK COMPLEX","city":"SECUNDERABAD","supplier":"CREDENCE INTERNATIONAL","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"T.P.H.GMPH","customerCountry":"GERMANY","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1325","totalValueFC":"97832.9","currency":"USD","unitRateINR":109607.51226666667,"date":"11-Oct-2024","totalValueINR":"8220563.42","totalValueInUsd":"97832.9","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"4759285","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"706 SWAPNALOK COMPLEX, SECUNDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732041000,"product":"HYOSCINE N-BUTYLBROMIDE IP","address":"3, BOTAWALA BLDG., 1ST FLOOR,","city":"FORT, MUMBAI MAHARASHTRA","supplier":"NISHCHEM INTERNATIONAL PVT. LTD","supplierCountry":"INDIA","foreign_port":"BIRGUNJ","customer":"TO THE ORDER OF MARUTI PHARMA P.LTD","customerCountry":"NEPAL","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"88000","totalValueFC":"3128.4","currency":"INR","unitRateINR":88000,"date":"20-Nov-2024","totalValueINR":"264000","totalValueInUsd":"3128.4","indian_port":"Raxaul","hs_no":"29391900","bill_no":"5766869","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Raxaul","supplierAddress":"3, BOTAWALA BLDG., 1ST FLOOR,, FORT, MUMBAI MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735583400,"product":"HYOSCINE BUTYL BROMIDE PH. EUR (HYOSCINEN-BUTYL BROMIDE PH.EUR)(BULK DRUG IN POWDER FORM)","address":"8, BENTINCK STREET","city":"KOLKATA (W.B.)","supplier":"ALKALOIDS CORPORATION","supplierCountry":"INDIA","foreign_port":"SAN SALVADOR","customer":"LABORATORIES MEDIKEM, S.A.DE C.V.","customerCountry":"EL SALVADOR","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1661.2","totalValueFC":"8235.9","currency":"USD","unitRateINR":139959.20000000001,"date":"31-Dec-2024","totalValueINR":"699796","totalValueInUsd":"8235.9","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"6929741","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EL SALVADOR","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8, BENTINCK STREET, KOLKATA (W.B.)","customerAddress":""},{"dataSource":"API Import","activeIngredients":"HYOSCINE BUTYL BROMIDE","year":"2021","qtr":"Q1","strtotime":1610908200,"product":"HYOSCINE BUTYL BROMIDE IP","address":"54-A, SIR MATHURDAS VASANJI ROAD,ANDHERI (EAST)","city":"MUMBAI, MAHARASHTRA","supplier":"SANOFI","supplierCountry":"ITALY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SANOFI","customerCountry":"INDIA","quantity":"318.55","actualQuantity":"318.55","unit":"KGS","unitRateFc":"722","totalValueFC":"288683.1","currency":"EUR","unitRateINR":"66279.6","date":"18-Jan-2021","totalValueINR":"21113366.58","totalValueInUsd":"288683.1","indian_port":"BOMBAY AIR","hs_no":"29397990","bill_no":"2407358","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"","customerAddress":"54-A, SIR MATHURDAS VASANJI ROAD,ANDHERI (EAST)"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669141800,"product":"HYOSCINE BUTYL BROMIDE BP\/PH.EUR 09D3A","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"ALKALOIDS OF AUSTRALIA","supplierCountry":"AUSTRALIA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"1700","totalValueFC":"43014.2","currency":"USD","unitRateINR":"140420","date":"23-Nov-2022","totalValueINR":"3510500","totalValueInUsd":"43014.2","indian_port":"BOMBAY AIR","hs_no":"29397900","bill_no":"3426580","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRALIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677868200,"product":"BUTYLSCOPOLAMINE MICRONIZED","address":"TORRENT HOUSE, OFF ASHRAM ROAD,","city":"AHMEDABAD","supplier":"M\/S. LINNEA SA","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"35.00","actualQuantity":"35","unit":"KGS","unitRateFc":"1480","totalValueFC":"52587","currency":"USD","unitRateINR":"123580","date":"04-Mar-2023","totalValueINR":"4325300","totalValueInUsd":"52587","indian_port":"BOMBAY AIR","hs_no":"29397900","bill_no":"4905291","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"TORRENT HOUSE, OFF ASHRAM ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685385000,"product":"HYOSCINE BUTYL BROMIDE IP","address":"3RD & 4TH FLOORS,H.NO. 5-10-173,F ATEH MAIDAN ROAD,BASHEERBAGH","city":"HYDERABAD","supplier":"SANOFI","supplierCountry":"ITALY","foreign_port":"FRANKFURT MAIN INT L","customer":"SANOFI","customerCountry":"INDIA","quantity":"346.90","actualQuantity":"346.9","unit":"KGS","unitRateFc":"722","totalValueFC":"276839.3","currency":"EUR","unitRateINR":"65665.9","date":"30-May-2023","totalValueINR":"22779500.71","totalValueInUsd":"276839.3","indian_port":"BOMBAY AIR","hs_no":"29397900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Italy","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT MAIN INT L","supplierAddress":"","customerAddress":"3RD & 4TH FLOORS,H.NO. 5-10-173,F ATEH MAIDAN ROAD,BASHEERBAGH"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710354600,"product":"HYOSCINE BUTYL BROMIDE IP","address":"3RD 4TH FLOORS, H.NO. 5-10-173","city":"HYDERABAD, AP","supplier":"SANOFI","supplierCountry":"ITALY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SANOFI","customerCountry":"INDIA","quantity":"350.00","actualQuantity":"350","unit":"KGS","unitRateFc":"722","totalValueFC":"279676.2","currency":"EUR","unitRateINR":"66351.8","date":"14-Mar-2024","totalValueINR":"23223130","totalValueInUsd":"279676.2","indian_port":"Bombay Air","hs_no":"29397900","bill_no":"2571845","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"38 BEACH ROAD # 18-11 SOUTH BEACH TOWER SINGAPORE 189767 Singapore, ,Singapore Singapore","customerAddress":"3RD 4TH FLOORS, H.NO. 5-10-173"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"HYOSCINE N-BUTYLBROMIDE EP (CAS NO.149-64-4) IUPAC NAME (7(S)-(LA,2P,4P,SA,7P)-9-BUTYL-7-(3-HYDROXY-1-OXO-2-PHENYLPROPOX","address":"301 CEEJAY HOUSE LEVEL 3 SHIVSAGAR","city":"MUMBAI,MAHARASHTRA","supplier":"XXSTRXXIANXXLKAXXIDSXXADIXX PTXXLTD","supplierCountry":"AUSTRALIA","foreign_port":"BRISBANE","customer":"ARSHIYA LOGISTICS SERVICES LTD","customerCountry":"INDIA","quantity":"260.00","actualQuantity":"260","unit":"KGS","unitRateFc":"2511.5","totalValueFC":"660800.5","currency":"USD","unitRateINR":"211848","date":"09-May-2024","totalValueINR":"55080480","totalValueInUsd":"660800.5","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29398000","bill_no":"1006624","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRALIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRISBANE","supplierAddress":"N\/A","customerAddress":"301 CEEJAY HOUSE LEVEL 3 SHIVSAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721845800,"product":"BUTYLSCOPOLAMINE SUITABLE FOR INJECTABLE","address":"PLOT NO.58-D,GOVT. INDL.ESTATE,","city":"MUMBAI ,MAHARASHTRA","supplier":"LINNEA SA","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"RUSAN PHARMA","customerCountry":"INDIA","quantity":"8.50","actualQuantity":"8.5","unit":"KGS","unitRateFc":"1400","totalValueFC":"12036.5","currency":"USD","unitRateINR":"118370","date":"25-Jul-2024","totalValueINR":"1006145","totalValueInUsd":"12036.5","indian_port":"Bombay Air","hs_no":"29397900","bill_no":"4684165","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Sterile","supplierPort":"ZURICH","supplierAddress":"VIA CANTONALE 6595 RIAZZINOSWITZERLANDSWITZERLAND SWITZERLAND","customerAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734028200,"product":"HYOSCINE N-BUTYLBROMIDE EP (CAS NO.149-64-4) (IUPAC NAME: [7 (S)-(LA,2P,4P, SA,7P)]-9-BUTYL-7-(3-HYDROXY-1-OXO-2-PHENYLP","address":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"N\/A","supplierCountry":"AUSTRALIA","foreign_port":"BRISBANE","customer":"SUPRIYA LIFESCIENCE","customerCountry":"INDIA","quantity":"180.00","actualQuantity":"180","unit":"KGS","unitRateFc":"1502","totalValueFC":"272521.2","currency":"USD","unitRateINR":"128643.6","date":"13-Dec-2024","totalValueINR":"23155848","totalValueInUsd":"272521.2","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29398000","bill_no":"7212760","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRALIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRISBANE","supplierAddress":"N\/A","customerAddress":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,"}]
18-Jan-2021
31-Dec-2024
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ABOUT THIS PAGE

Scobutyl Manufacturers

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

Scobutyl Suppliers

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

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

Scobutyl USDMF

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

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

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

Scobutyl 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 Scobutyl Drug Master File in Japan (Scobutyl JDMF) empowers Scobutyl 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 Scobutyl JDMF during the approval evaluation for pharmaceutical products. At the time of Scobutyl 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 Scobutyl suppliers with JDMF on PharmaCompass.

Scobutyl KDMF

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

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

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

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

Scobutyl CEP

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

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

Scobutyl WC

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

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

Scobutyl 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 Scobutyl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Scobutyl GMP

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

Scobutyl CoA

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

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

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