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Also known as: 23828-92-4, Ambroxol hcl, Mucoangin, Mucosolvan, Ambroxolhydrochloride, 1384955-66-1
Molecular Formula
C13H19Br2ClN2O
Molecular Weight
414.56  g/mol
InChI Key
QNVKOSLOVOTXKF-UHFFFAOYSA-N
FDA UNII
R3593UZ7HS

Ambroxol Hydrochloride
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
1 2D Structure

Ambroxol Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;hydrochloride
2.1.2 InChI
InChI=1S/C13H18Br2N2O.ClH/c14-9-5-8(13(16)12(15)6-9)7-17-10-1-3-11(18)4-2-10;/h5-6,10-11,17-18H,1-4,7,16H2;1H
2.1.3 InChI Key
QNVKOSLOVOTXKF-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC(CCC1NCC2=C(C(=CC(=C2)Br)Br)N)O.Cl
2.2 Other Identifiers
2.2.1 UNII
R3593UZ7HS
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-(((2-amino-3,5-dibromophenyl)methyl)amino)cyclohexanol

2. Abrohexal

3. Am, Bisolvon

4. Ambril

5. Ambro Puren

6. Ambro-puren

7. Ambrobeta

8. Ambrofur

9. Ambrohexal

10. Ambrols

11. Ambrolitic

12. Ambropp

13. Ambropuren

14. Ambroten

15. Ambroxin

16. Ambroxocompren

17. Ambroxol

18. Bisolvon Am

19. Bromhexine Metabolite Viii

20. Bronchopront

21. Bronchowern

22. Broxol

23. Contac Husten Trunk

24. Contac Husten-trunk

25. Contac Hustentrunk

26. Dinobroxol

27. Duramucal

28. Ebromin

29. Expeflen

30. Expit

31. Farmabroxol

32. Flavamed

33. Frenopect

34. Gelopol

35. Hustenlser, Pect

36. Hustenlser, Therapin

37. Larylin Husten Lser

38. Larylin Husten-lser

39. Larylin Hustenlser

40. Lasolvan

41. Metabolite Viii, Bromhexine

42. Mibrox

43. Motosol

44. Muco Fips

45. Muco-fips

46. Mucofips

47. Mucosolvan

48. Mucotablin

49. Na 872

50. Na-872

51. Na872

52. Pdiamuc

53. Pect Hustenlser

54. Pulmonal S

55. Pulmonal, Ringelheimer

56. Ringelheimer Pulmonal

57. Sekretovit

58. Stas Hustenlser

59. Stas-hustenlser

60. Stashustenlser

61. Surbronc

62. Therapin Hustenlser

2.3.2 Depositor-Supplied Synonyms

1. 23828-92-4

2. Ambroxol Hcl

3. Mucoangin

4. Mucosolvan

5. Ambroxolhydrochloride

6. 1384955-66-1

7. 1146648-86-3

8. Lasolvan

9. 15942-05-9

10. Trans-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride

11. Ambroxol Impurity D Hcl

12. 4-((2-amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol Hydrochloride

13. Cis-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride

14. Ambroxol Hydrochloride [jan]

15. Ambroxol Hydrochloride

16. Ambroxol (hydrochloride)

17. Ambroxol Hydrochloride, Cis-

18. 4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;hydrochloride

19. Cc995zmv90

20. R3593uz7hs

21. Ambroxol Impurity D Hydrochloride

22. Na-872

23. Mfcd00078932

24. Nsc-758224

25. Ambroxol Hydrochloride (jan)

26. Ambroxol Hydrochloride 100 Microg/ml In Acetonitrile

27. Mucolear

28. Ambroxol Lozenge

29. Cis-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride

30. Cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, Hydrochloride (1:1), Cis-

31. Smr000875269

32. Na 872 Hydrochloride

33. Ncgc00016781-04

34. Cas-23828-92-4

35. Unii-cc995zmv90

36. Lazolvan

37. Ponophen

38. 4-(2-amino-3,5-dibromobenzylamino)cyclohexanol Hydrochloride

39. Ccris 8686

40. Mucosolvan-l

41. Sr-05000001463

42. Mucosal-l

43. Trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride

44. Hustless (tn)

45. Prestwick_717

46. Einecs 245-899-2

47. Dsstox_cid_25442

48. Dsstox_rid_80883

49. Unii-r3593uz7hs

50. Dsstox_gsid_45442

51. Schembl99455

52. Ambroxol Hydrochloride ,(s)

53. Ambroxol Hydrochloride, 98%

54. Mls001333105

55. Mls001333106

56. Mls002153788

57. Spectrum1503080

58. (e)-4-hdmb

59. Na-872et

60. Chembl1514634

61. Dtxsid2045442

62. Chebi:31198

63. Hy-b1039a

64. Dtxsid60936098

65. Exr-202

66. Hms1569i13

67. Hms1922c19

68. Pharmakon1600-01503080

69. Ambroxol Hydrochloride [mi]

70. 4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride

71. Bcp04490

72. Tox21_110607

73. Ac-024

74. Ccg-39174

75. Nsc758224

76. S3064

77. (1r,4r)-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride

78. Akos015895175

79. Akos015951294

80. Akos024462505

81. Ambroxol Hydrochloride [mart.]

82. Ambroxol Hydrochloride [who-dd]

83. Bcp9000284

84. Ccg-220366

85. Ks-5248

86. Nsc 758224

87. Ncgc00016781-03

88. Ncgc00092387-01

89. Ncgc00094999-01

90. Ncgc00094999-02

91. Ba166015

92. Sy052506

93. Ambroxol Hydrochloride, Analytical Standard

94. Bcp0726000073

95. Ambroxol Hydrochloride [ep Impurity]

96. Ambroxol Hydrochloride [ep Monograph]

97. B2267

98. Cs-0013219

99. Ft-0630506

100. Sw198832-2

101. A16398

102. D01479

103. H11915

104. A816928

105. Sr-01000837516

106. Q-100980

107. Sr-01000837516-3

108. Sr-05000001463-2

109. Q27275396

110. Ambroxol Hydrochloride Pound Ep2001/cp2000 Pound(c)

111. F1131-0002

112. Ambroxol Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

113. Trans-4-(2-amino-3,5-dibromobenzylamino)cyclohexanol Hydrochloride

114. (1r,4r)-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol Hydrochloride

115. (1r,4r)-4-(2-amino-3,5-dibromobenzylamino)cyclohexanol Hydrochloride

116. 4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride, Aldrichcpr

117. Ambroxol Hydrochloride, European Pharmacopoeia (ep) Reference Standard

118. Cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)-, Hydrochloride, Trans-

119. Cyclohexanol, 4-(n-(2-amino-3,5-dibromobenzyl)amino)-, Hydrochloride (e)-

120. Cyclohexanol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-, Hydrochloride

121. Cyclohexanol,4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-,hydrochloride

122. Trans-4-((2-amino-3,5-dibromobenzyl)-amino)cyclohexanol Hydrochloride

123. 4-{[(2-amino-3,5-dibromophenyl)methyl]amino}cyclohexan-1-ol--hydrogen Chloride (1/1)

124. Cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, Monohydrochloride, Trans-

125. Cyclohexanol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-, Hydrochloride (1:1), Trans-

126. Imp. D (ep): Cis-4-[(2-amino-3,5-dibromobenzyl)amino]-cyclohexanol Hcl

127. Trans-4-(((2-amino-3,5-dibromophenyl)methyl)amino)cyclohexan-1-ol Hydrochloride

128. Trans-4-[[(2-amino-3,5-dibromo-phenyl)methyl]amino]-cyclohexanol Hydrochloride

129. Trans-4-[[(2-amino-3,5-dibromophenyl)methyl]amino]cyclohexanol Hydrochloride

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 414.56 g/mol
Molecular Formula C13H19Br2ClN2O
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass413.95322 g/mol
Monoisotopic Mass411.95527 g/mol
Topological Polar Surface Area58.3 Ų
Heavy Atom Count19
Formal Charge0
Complexity259
Isotope Atom Count0
Defined Atom Stereocenter Count0
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

Expectorants

Agents that increase mucous excretion. Mucolytic agents, that is drugs that liquefy mucous secretions, are also included here. (See all compounds classified as Expectorants.)


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Ambroxol Hydrochloride EP

Date of Issue : 2022-08-18

Valid Till : 2025-06-26

Written Confirmation Number : WC-0054

Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra,City Karakhadi -391450...

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Date of Issue : 2023-01-27

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Written Confirmation Number : WC-0348

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Date of Issue : 2023-04-18

Valid Till : 2026-01-03

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Date of Issue : 2023-03-21

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LTD","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"UNDISCLOSED","customerCountry":"INDONESIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"35","totalValueFC":"69089.8","currency":"USD","unitRateINR":2973.1387,"date":"24-Jul-2025","totalValueINR":"5946277.4","totalValueInUsd":"69089.8","indian_port":"JNPT","hs_no":"29420090","bill_no":"3843357","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753381800,"product":"PHARMACEUTICAL RAW MATERIAL (ACTIVE PHARMACEUTICAL INGREDIENTS) AMBROXOL HYDROCHLORIDE BP","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,","city":"BOMBAY ,MAHARASHTRA","supplier":"ANUH PHARMA LTD","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"UNDISCLOSED","customerCountry":"INDONESIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"36.5","totalValueFC":"36090.4","currency":"USD","unitRateINR":3106.1500000000001,"date":"25-Jul-2025","totalValueINR":"3106150","totalValueInUsd":"36090.4","indian_port":"JNPT","hs_no":"29420090","bill_no":"3884513","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753468200,"product":"BULK DRUG (AMBROXOL HCL EP)","address":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD","city":"RAICHUR","supplier":"SHILPA PHARMA LIFESCIENCES LTD","supplierCountry":"INDIA","foreign_port":"BUSAN(KOREA)","customer":"KEB HANA BANK INTERNATIONAL","customerCountry":"KOREA, REPUBLIC OF","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"74","totalValueFC":"36539.4","currency":"USD","unitRateINR":6289.6000000000004,"date":"26-Jul-2025","totalValueINR":"3144800","totalValueInUsd":"36539.4","indian_port":"Madras Sea","hs_no":"29222190","bill_no":"3918200","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Sea","supplierAddress":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD, RAICHUR","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753641000,"product":"BULK DRUG (AMBROXOL HCL EP)","address":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD","city":"RAICHUR","supplier":"SHILPA PHARMA LIFESCIENCES LTD","supplierCountry":"INDIA","foreign_port":"HO CHI MINH C","customer":"SANOFI VIETNAM SHARE HOLDING COMPAN","customerCountry":"VIETNAM","quantity":"350.00","actualQuantity":"350","unit":"KGS","unitRateFc":"67","totalValueFC":"22411.3","currency":"USD","unitRateINR":5510.9971428571425,"date":"28-Jul-2025","totalValueINR":"1928849","totalValueInUsd":"22411.3","indian_port":"Madras Air","hs_no":"29222190","bill_no":"3951137","productDescription":"API","marketType":"","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD, RAICHUR","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753641000,"product":"AMBROXOL HYDROCHLORIDE B. P.","address":"16-18\/B, VATSA HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"VEN PETROCHEM PHARMA INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MANZANILLO","customer":"SINBIOTIK INTERNACIONAL S A DE CV","customerCountry":"MEXICO","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"44.3","totalValueFC":"64484.2","currency":"USD","unitRateINR":3699.9299999999998,"date":"28-Jul-2025","totalValueINR":"5549895","totalValueInUsd":"64484.2","indian_port":"JNPT","hs_no":"29420090","bill_no":"3933319","productDescription":"API","marketType":"","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"16-18\/B, VATSA HOUSE, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753727400,"product":"PHARMACEUTICAL INTERMEDIATE HARMLESS PHARMA GRADE RAW MATERIALS - AMBROXOL HYDROCHLORIDE EP","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,","city":"BOMBAY ,MAHARASHTRA","supplier":"ANUH PHARMA LTD","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"UNDISCLOSED","customerCountry":"CHINA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"25.5","totalValueFC":"125918.8","currency":"USD","unitRateINR":2167.4629600000003,"date":"29-Jul-2025","totalValueINR":"10837314.8","totalValueInUsd":"125918.8","indian_port":"JNPT","hs_no":"29420090","bill_no":"3970606","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753813800,"product":"PHARMACEUTICAL RAW MATERIAL (ACTIVE PHARMACEUTICAL INGREDIENTS)- AMBROXOL HYDROCHLORIDE BP","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,","city":"BOMBAY ,MAHARASHTRA","supplier":"ANUH PHARMA LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"UNDISCLOSED","customerCountry":"BANGLADESH","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"38","totalValueFC":"1868.8","currency":"USD","unitRateINR":3216.7800000000002,"date":"30-Jul-2025","totalValueINR":"160839","totalValueInUsd":"1868.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4009350","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,, BOMBAY ,MAHARASHTRA","customerAddress":""}]
03-Jan-2022
30-Jul-2025
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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

CAS Number : 134-20-3

End Use API : Ambroxol Hydrochloride

About The Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynth...

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02

EPSC
Not Confirmed
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EPSC
Not Confirmed
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CAS Number : 23828-92-4

End Use API : Ambroxol Hydrochloride

About The Company : Bajaj Healthcare Ltd. is a company established in 1993, services various Pharmaceuticals, Nutraceutical and Food industries globally with a spirit of scrupulous...

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03

EPSC
Not Confirmed
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EPSC
Not Confirmed
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CAS Number : 23828-92-4

End Use API : Ambroxol Hydrochloride

About The Company : Bajaj Healthcare Ltd. is a company established in 1993, services various Pharmaceuticals, Nutraceutical and Food industries globally with a spirit of scrupulous...

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04

EPSC
Not Confirmed
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EPSC
Not Confirmed
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CAS Number : 50910-55-9

End Use API : Ambroxol Hydrochloride

About The Company : Maisuriya Pharma Solutions is a research-driven & technology-oriented company. Continuous innovations & improvement are the lifeblood of our business. Our major...

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05

NAM Group

India
EPSC
Not Confirmed
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NAM Group

India
EPSC
Not Confirmed
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CAS Number : 50910-55-9

End Use API : Ambroxol Hydrochloride

About The Company : NAM Group of Industries is a prominent manufacturer and exporter of pharmaceutical API’s for both human and veterinary use, along with pharmaceutical intermed...

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06

EPSC
Not Confirmed
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EPSC
Not Confirmed
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CAS Number : 50910-55-9

End Use API : Ambroxol Hydrochloride

About The Company : Riddhi Pharma was set up in 1997 as a Manufacturer of API’s Intermediates and Fine Chemicals, especially in the field of Friedel Crafts Reaction / Bromination...

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07

EPSC
Not Confirmed
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EPSC
Not Confirmed
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CAS Number : CAS-50910-55-9

End Use API : Ambroxol Hydrochloride

About The Company : Shreeneel Chemicals is dedicated to quality healthcare development and fostering a knowledgeable environment. The company was founded by Mr. Sanjay Tavethiya an...

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08

EPSC
Not Confirmed
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EPSC
Not Confirmed
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CAS Number :

End Use API : Ambroxol Hydrochloride

About The Company : Manufacturers and Exporters of speciality fine chemicals, speciality solvents, Pharma Intermediates, Agro Intermediates, Cosmetic ingredients and nutraceutical ...

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09

EPSC
Not Confirmed
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EPSC
Not Confirmed
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CAS Number : CAS-50910-55-9

End Use API : Ambroxol Hydrochloride

About The Company : Venkata Narayana Active Ingredients (Formerly Nutra Specialties Private Limited) Promoted by a well-known business house of India, Mr. Abhaya Kumar Jain who has...

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Europe

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01

2care4 ApS

Denmark
Georgia Environmental
Not Confirmed
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2care4 ApS

Denmark
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Georgia Environmental
Not Confirmed

Flupentiksoldihydroklorid

Brand Name : Fluanxol

Dosage Form : Tablet, film-coated

Dosage Strength : 1 mg

Packaging : Boks av plast 100item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

Accord Healthcare B.V.

United Kingdom
Georgia Environmental
Not Confirmed
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Accord Healthcare B.V.

United Kingdom
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Georgia Environmental
Not Confirmed

Metoklopramidhydrokloridmonohydrat

Brand Name : Metoclopramide Accord

Dosage Form : Tablet

Dosage Strength : 10 mg

Packaging : Blisterpakning 50item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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03

Georgia Environmental
Not Confirmed
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Georgia Environmental
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ambroxolhydroklorid

Brand Name : Rivendra

Dosage Form : ORAL LÖSNING

Dosage Strength : 3 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

Farmak JSC

Ukraine
Georgia Environmental
Not Confirmed
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Farmak JSC

Ukraine
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Georgia Environmental
Not Confirmed

Ambroxol Hydrochloride; S-Carboxymethyl-L-Cysteine

Brand Name : Pectolvan C

Dosage Form : Oral Syrup

Dosage Strength :

Packaging : 100ML Glass Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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05

H. Lundbeck A/S

Denmark
Georgia Environmental
Not Confirmed
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H. Lundbeck A/S

Denmark
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Georgia Environmental
Not Confirmed

Flupentiksoldihydroklorid

Brand Name : Fluanxol

Dosage Form : Tablet, film-coated

Dosage Strength : 5 mg

Packaging : Boks av plast 100item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Ambroxol Hydrochloride

Brand Name : Ambreks

Dosage Form : Syrup

Dosage Strength : 30MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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07

Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Metoklopramidhydroklorid

Brand Name : Afipran

Dosage Form : Tablet

Dosage Strength : 10 mg

Packaging : Boks av plast 50item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Metoklopramidhydrokloridmonohydrat

Brand Name : Metoclopramide Orifarm

Dosage Form : Tablet

Dosage Strength : 10 mg

Packaging : Blisterpakning 50item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Metoklopramidhydrokloridmonohydrat

Brand Name : Metoclopramide Orifarm

Dosage Form : Tablet

Dosage Strength : 10 mg

Packaging : Blisterpakning 20item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Ambroxol Hydrochloride

Brand Name :

Dosage Form : MICROPELLET CAPSULE

Dosage Strength : 75MG

Packaging : 10 Or 20 Capsules

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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ABOUT THIS PAGE

Looking for 1384955-66-1 / Ambroxol Hydrochloride API manufacturers, exporters & distributors?

Ambroxol Hydrochloride manufacturers, exporters & distributors 1

41

PharmaCompass offers a list of Ambroxol Hydrochloride 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 Ambroxol Hydrochloride manufacturer or Ambroxol Hydrochloride supplier for your needs.

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

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

API | Excipient name

Ambroxol Hydrochloride

Synonyms

23828-92-4, Ambroxol hcl, Mucoangin, Mucosolvan, Ambroxolhydrochloride, 1384955-66-1

Cas Number

1384955-66-1

Unique Ingredient Identifier (UNII)

R3593UZ7HS

About Ambroxol Hydrochloride

A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.

Ambroxol HCl Manufacturers

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

Ambroxol HCl Suppliers

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

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

Ambroxol HCl USDMF

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

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

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

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

Ambroxol HCl KDMF

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

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

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

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

Ambroxol HCl CEP

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

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

Ambroxol HCl WC

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

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

Ambroxol HCl 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 Ambroxol HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ambroxol HCl GMP

Ambroxol HCl 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 Ambroxol HCl 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 Ambroxol HCl GMP manufacturer or Ambroxol HCl GMP API supplier for your needs.

Ambroxol HCl CoA

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

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

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