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Synopsis

Synopsis

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Chemistry

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Also known as: 2753-45-9, Mebeverine hcl, Duspatalin, Colofac, Csag-144, Csag 144
Molecular Formula
C25H36ClNO5
Molecular Weight
466.0  g/mol
InChI Key
PLGQWYOULXPJRE-UHFFFAOYSA-N
FDA UNII
15VZ5AL4JN

Mebeverine
Mebeverine Hydrochloride is the hydrochloride salt form of mebeverine, an orally bioavailable reserpine derivative and anticholinergic agent, with spasmolytic activity. Upon administration, mebeverine targets, binds to and blocks the muscarinic receptors on smooth muscle cells in target tissues, such as the gastrointestinal (GI) tract, uterus, gallbladder and bladder. This prevents smooth muscle contraction and relaxes smooth muscle. Additionally, this may prevent spasms, ease pain and cramps in the GI tract and improve incontinence. In addition, mebeverine stabilizes excitable membranes by decreasing the permeability of ion channels and preventing intracellular calcium accumulation. This agent also blocks noradrenaline reuptake by sympathetic nerve endings and exerts a local anesthetic effect.
1 2D Structure

Mebeverine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[ethyl-[1-(4-methoxyphenyl)propan-2-yl]amino]butyl 3,4-dimethoxybenzoate;hydrochloride
2.1.2 InChI
InChI=1S/C25H35NO5.ClH/c1-6-26(19(2)17-20-9-12-22(28-3)13-10-20)15-7-8-16-31-25(27)21-11-14-23(29-4)24(18-21)30-5;/h9-14,18-19H,6-8,15-17H2,1-5H3;1H
2.1.3 InChI Key
PLGQWYOULXPJRE-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCN(CCCCOC(=O)C1=CC(=C(C=C1)OC)OC)C(C)CC2=CC=C(C=C2)OC.Cl
2.2 Other Identifiers
2.2.1 UNII
15VZ5AL4JN
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-(ethyl-(4-methoxy-alpha-methylphenethyl)aminobutyl) Veratrate

2. Duspatalin

3. Mebeverine

4. Spasmotalin

2.3.2 Depositor-Supplied Synonyms

1. 2753-45-9

2. Mebeverine Hcl

3. Duspatalin

4. Colofac

5. Csag-144

6. Csag 144

7. Mebeverine Hydrochloride [usan]

8. Mebeverine (hydrochloride)

9. Nsc-169101

10. 15vz5al4jn

11. 4-[ethyl-[1-(4-methoxyphenyl)propan-2-yl]amino]butyl 3,4-dimethoxybenzoate;hydrochloride

12. Mls000028652

13. Duspatal

14. Benzoic Acid, 3,4-dimethoxy-, 4-(ethyl(2-(4-methoxyphenyl)-1-methylethyl)amino)butyl Ester, Hydrochloride

15. Rudakol

16. Smr000058862

17. Dsstox_cid_25372

18. Dsstox_rid_80834

19. Dsstox_gsid_45372

20. Mebeverine Hydrochloride (usan)

21. 4-(ethyl(1-(4-methoxyphenyl)propan-2-yl)amino)butyl 3,4-dimethoxybenzoate Hydrochloride

22. 4-{ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino}butyl 3,4-dimethoxybenzoate Hydrochloride

23. Nsc 169101

24. Nsc169101

25. Einecs 220-400-0

26. Unii-15vz5al4jn

27. Sr-01000003159

28. 4-(ethyl(p-methoxy-.alpha.-methylphenethyl)amino)butyl Veratrate Hydrochloride

29. 4-[ethyl(p-methoxy-.alpha.-methylphenethyl)amino]butyl Veratrate Hydrochloride

30. Prestwick_587

31. Mebeverine D6 Hcl

32. Colofac Hydrochloride

33. Duspatal Hydrochloride

34. Duspatalin Hydrochloride

35. Opera_id_1589

36. Ncgc00016617-01

37. 4-(ethyl(p-methoxy-alpha-methylphenethyl)amino)butyl Veratrate Hydrochloride

38. Cas-2753-45-9

39. Mls001148590

40. Mls002222299

41. Schembl121977

42. Spectrum1501117

43. Regid_for_cid_17683

44. Chembl1446650

45. Dtxsid1045372

46. Hms1568n22

47. Hms1921f15

48. Pharmakon1600-01501117

49. Bcp28149

50. Ex-a4568

51. Hy-a0078

52. Tox21_110527

53. Ccg-39022

54. Mebeverine Hydrochloride [mi]

55. Mfcd00083411

56. Nsc757840

57. S5027

58. Akos027420570

59. Tox21_110527_1

60. Cs-6931

61. Nsc-757840

62. 4-[ethyl-[1-(4-methoxyphenyl)propan-2-yl]amino]butyl 3,4-dimethoxybenzoate Hydrochloride

63. Mebeverine Hydrochloride [mart.]

64. Veratric Acid, 4-(ethyl(p-methoxy-alpha-methylphenethyl)amino)butyl Ester, Hydrochloride

65. Mebeverine Hydrochloride [who-dd]

66. Ncgc00018277-06

67. Ncgc00094900-01

68. Ncgc00094900-02

69. Ncgc00094900-03

70. 3,4-dimethoxybenzoic Acid 4-[ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl Ester Hydrochloride

71. Veratric Acid, Butyl Ester, Hydrochloride

72. Db-047240

73. Ft-0603620

74. Mebeverine Hydrochloride, Analytical Standard

75. D04868

76. Mebeverine Hydrochloride [ep Monograph]

77. N16922

78. Wln: 1or Bo1 Dvo4n2&y1&1r Do1 &gh

79. 753m459

80. A819105

81. Sr-01000003159-4

82. W-109821

83. Mebeverine Hcl Pound>>csag-144 Pound>>csag 144 Pound>>csag144

84. 3,4-dimethoxybenzoicacid4-ethyl2-(4-methoxyphenyl)-1-methylethylaminobutylesterhydrochloride

85. 4-(ethyl(1-(4-methoxyphenyl)propan-2-yl)amino)butyl3,4-dimethoxybenzoatehydrochloride

86. Veratric Acid, 4-[ethyl(p-methoxy-.alpha.-methylphenethyl)amino]butyl Ester Hydrochloride

87. 3,4-dimethoxybenzoic Acid 4-[ethyl-[1-(4-methoxyphenyl)propan-2-yl]amino]butyl Ester Hydrochloride

88. Benzoic Acid,4-dimethoxy-, 4-[ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl Ester, Hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 466.0 g/mol
Molecular Formula C25H36ClNO5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count14
Exact Mass465.2282009 g/mol
Monoisotopic Mass465.2282009 g/mol
Topological Polar Surface Area57.2 Ų
Heavy Atom Count32
Formal Charge0
Complexity494
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

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.)


Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)


API SUPPLIERS

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Virtual BoothSynthokem Labs specializes in producing APIs and intermediates for the global pharma industry.

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CEP 2021-271 - Rev 00
Valid
Chemical
2023-09-25
2097
Synthokem Labs

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Certificate Number : CEP 2021-271 - Rev 00

Status : Valid

Issue Date : 2023-09-25

Type : Chemical

Substance Number : 2097

Synthokem Labs
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Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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CEP 2019-061 - Rev 03
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Chemical
2026-02-26
2097
Cohance

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Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Certificate Number : CEP 2019-061 - Rev 03

Status : Valid

Issue Date : 2026-02-26

Type : Chemical

Substance Number : 2097

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CEP 2022-476 - Rev 00
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Chemical
2025-08-29
2097
Cohance

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Certificate Number : CEP 2022-476 - Rev 00

Status : Valid

Issue Date : 2025-08-29

Type : Chemical

Substance Number : 2097

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Europe

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Mebeverine Hydrochloride

Brand Name : Mebeverina Aristo

Dosage Form : Film Coated Tablet

Dosage Strength : 135MG

Packaging :

Approval Date : 09-07-2020

Application Number : 85238

Regulatory Info : Cancelled

Registration Country : Spain

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Farmak JSC

Ukraine
RDD
Not Confirmed
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Farmak JSC

Ukraine
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RDD
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Mebeverina

Brand Name : Spark

Dosage Form : Capsule

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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RDD
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Mebeverine Hydrochloride

Brand Name : Medoverine

Dosage Form : Film Coated Tablet

Dosage Strength : 135MG

Packaging :

Approval Date : 2007-06-18

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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RDD
Not Confirmed
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Ispaghula Husks; Mebeverine Hydrochloride

Brand Name : Fybogel Mebeverine

Dosage Form : Granule For Oral Suspension

Dosage Strength : 3.5G; 135MG

Packaging :

Approval Date : 2006-04-24

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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RDD
Not Confirmed
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Mebeverina

Brand Name : Duspatalin

Dosage Form : Coated Tablet

Dosage Strength : 135MG

Packaging :

Approval Date : 01-04-1977

Application Number : 53900

Regulatory Info : Authorized

Registration Country : Spain

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Viatris Aps

U.S.A
RDD
Not Confirmed
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Viatris Aps

U.S.A
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Mebeverine Hydrochloride

Brand Name : Duspatalin Retard

Dosage Form : Prolonged-Release Capsules

Dosage Strength : 200mg

Packaging :

Approval Date : 20-06-2003

Application Number : 28103339102

Regulatory Info : Prescription

Registration Country : Denmark

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RDD
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Mebeverine

Brand Name :

Dosage Form : PELLET RETARD CAPSULE

Dosage Strength : 200MG

Packaging : 30 Capsules

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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Mebeverine

Brand Name : Duskonal retard

Dosage Form : Extended Release Capsule

Dosage Strength :

Packaging :

Approval Date : 25-07-2025

Application Number :

Regulatory Info :

Registration Country : Moldova

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Ecosse Limited

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Ecosse Limited

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Mebeverine Hydrochloride

Brand Name : Colofac Mr

Dosage Form : Prolonged-Release Hard Capsule

Dosage Strength : 200MG

Packaging :

Approval Date : 2018-09-05

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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NM Pharma Limited

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RDD
Not Confirmed
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NM Pharma Limited

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Mebeverine Hydrochloride

Brand Name : Colofac

Dosage Form : Coated Tablet

Dosage Strength : 135MG

Packaging :

Approval Date : 2021-07-19

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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Mebeverine manufacturers, exporters & distributors 1

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API | Excipient name

Mebeverine

Synonyms

2753-45-9, Mebeverine hcl, Duspatalin, Colofac, Csag-144, Csag 144

Cas Number

2753-45-9

Unique Ingredient Identifier (UNII)

15VZ5AL4JN

About Mebeverine

Mebeverine Hydrochloride is the hydrochloride salt form of mebeverine, an orally bioavailable reserpine derivative and anticholinergic agent, with spasmolytic activity. Upon administration, mebeverine targets, binds to and blocks the muscarinic receptors on smooth muscle cells in target tissues, such as the gastrointestinal (GI) tract, uterus, gallbladder and bladder. This prevents smooth muscle contraction and relaxes smooth muscle. Additionally, this may prevent spasms, ease pain and cramps in the GI tract and improve incontinence. In addition, mebeverine stabilizes excitable membranes by decreasing the permeability of ion channels and preventing intracellular calcium accumulation. This agent also blocks noradrenaline reuptake by sympathetic nerve endings and exerts a local anesthetic effect.

Duspatal Manufacturers

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

Duspatal Suppliers

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

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

Duspatal USDMF

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

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

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

Duspatal CEP

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

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

Duspatal WC

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

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

Duspatal GMP

Duspatal 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 Duspatal GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Duspatal GMP manufacturer or Duspatal GMP API supplier for your needs.

Duspatal CoA

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

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

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