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Chemistry

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Also known as: 132-69-4, Benzydamine hcl, Benzidamine hydrochloride, Benzindamine hydrochloride, Tantum, Benzydamine (hydrochloride)
Molecular Formula
C19H24ClN3O
Molecular Weight
345.9  g/mol
InChI Key
HNNIWKQLJSNAEQ-UHFFFAOYSA-N
FDA UNII
K2GI407R4Q

Benzydamine Hydrochloride
A benzyl-indazole having analgesic, antipyretic, and anti-inflammatory effects. It is used to reduce post-surgical and post-traumatic pain and edema and to promote healing. It is also used topically in treatment of RHEUMATIC DISEASES and INFLAMMATION of the mouth and throat.
1 2D Structure

Benzydamine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-(1-benzylindazol-3-yl)oxy-N,N-dimethylpropan-1-amine;hydrochloride
2.1.2 InChI
InChI=1S/C19H23N3O.ClH/c1-21(2)13-8-14-23-19-17-11-6-7-12-18(17)22(20-19)15-16-9-4-3-5-10-16;/h3-7,9-12H,8,13-15H2,1-2H3;1H
2.1.3 InChI Key
HNNIWKQLJSNAEQ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(C)CCCOC1=NN(C2=CC=CC=C21)CC3=CC=CC=C3.Cl
2.2 Other Identifiers
2.2.1 UNII
K2GI407R4Q
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Benzidamine

2. Benzindamine

3. Benzydamine

4. Benzydamine Monohydrochloride

5. Difflam

6. Hydrochloride, Benzydamine

7. Lonol

8. Monohydrochloride, Benzydamine

9. Novo Benzydamine

10. Novo-benzydamine

11. Opalgyne

12. Pms Benzydamine

13. Pms-benzydamine

14. Ratio Benzydamine

15. Ratio-benzydamine

16. Rosalgin

17. Sun Benz

18. Sun-benz

19. Tantum

20. Tantum Topico

2.3.2 Depositor-Supplied Synonyms

1. 132-69-4

2. Benzydamine Hcl

3. Benzidamine Hydrochloride

4. Benzindamine Hydrochloride

5. Tantum

6. Benzydamine (hydrochloride)

7. Af-864

8. Nsc-759276

9. 132-69-4 (hcl)

10. K2gi407r4q

11. Benalgin

12. {3-[(1-benzyl-1h-indazol-3-yl)oxy]propyl}dimethylamine Hydrochloride

13. 1-benzyl-3-(3-(dimethylamino)propoxy)-1h-indazole Monohydrochloride

14. 3-((1-benzyl-1h-indazol-3-yl)oxy)-n,n-dimethylpropan-1-amine Hydrochloride

15. 1-propanamine, N,n-dimethyl-3-((1-(phenylmethyl)-1h-indazol-3-yl)oxy)-, Monohydrochloride

16. Benzidan

17. Benzyrin

18. Difflam

19. Dorinamin

20. Enzamin

21. Epirotin

22. Flogaton

23. Imotryl

24. Oxinazin

25. Ririlim

26. Riripen

27. Salyzoron

28. Tamas

29. Verax

30. 1-benzyl-3-(3-(dimethylamino)propoxy)-1h-indazole Hydrochloride

31. 1-benzyl-3-(3-[dimethylamino]propoxy)-1h-indazole Hydrochloride

32. Dsstox_cid_25293

33. Dsstox_rid_80786

34. Dsstox_gsid_45293

35. 1-benzyl-3-[3-(dimethylamino)propoxy]-1h-indazole Hydrochloride

36. 3-(1-benzylindazol-3-yl)oxy-n,n-dimethylpropan-1-amine;hydrochloride

37. Smr000544402

38. Ncgc00016397-01

39. Cas-132-69-4

40. Einecs 205-076-0

41. Af 864

42. Af864

43. Benzydamine Hydrochloride [usan:jan]

44. Unii-k2gi407r4q

45. Sr-01000799149

46. Benzydamine, Hcl

47. Prestwick_403

48. Tantum (tn)

49. 1-benzyl-3-gamma-dimethylaminopropoxy-1h-indazole Hydrochloride

50. 1-propanamine, N,n-dimethyl-3-((1-(phenylmethyl)-1h-indazol-3-yl)oxy)-, Hydrochloride

51. Schembl42644

52. Benzydaminehydrochloride

53. Mls001216204

54. Mls001306431

55. Mls001333107

56. Mls001333108

57. Mls002222210

58. Not Available;benzydamine Hcl

59. Benzydamine-[d6] Hydrochloride

60. Chembl1528134

61. Dtxsid1045293

62. Chebi:31266

63. Hms1568l16

64. Pharmakon1600-01505975

65. Bcp12133

66. Tox21_110420

67. Hy-30235a

68. Mfcd00078957

69. Nsc759276

70. S4165

71. Benzydamine Hydrochloride (jan/usan)

72. Benzydamine Hydrochloride [mi]

73. 1h-indazole, 1-benzyl-3-(3-(dimethylamino)propoxy)-, Monohydrochloride

74. 3-((1-benzyl-1h-indazol-3-yl)oxy)-n,n-dimethylpropylamine Monohydrochloride

75. Akos015994635

76. Tox21_110420_1

77. Ac-6791

78. Benzydamine Hydrochloride [jan]

79. Ccg-213582

80. Cs-4463

81. Hs-1002

82. Nsc 759276

83. Benzydamine Hydrochloride [usan]

84. Benzydamine Hydrochloride [mart.]

85. Ncgc00016397-04

86. Benzydamine Hydrochloride [who-dd]

87. 1-benzyl-3-hydroxy-1h-indazolesodiumsalt

88. B3751

89. Ft-0662621

90. Sw196646-3

91. Benzydamine Hydrochloride, Analytical Standard

92. A14562

93. Benzydamine Hydrochloride [ep Monograph]

94. D01410

95. H10439

96. A854848

97. J-006209

98. Sr-01000799149-4

99. Q27281858

100. 1-benzyl-3-(3-(dimethylamino) Propoxy)-1h Indozale Hydrochloride

101. 3-(1-benzyl-1h-indazol-3-yloxy)-n,n-dimethylpropan-1-amine Hydrochloride

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 345.9 g/mol
Molecular Formula C19H24ClN3O
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count7
Exact Mass345.1607901 g/mol
Monoisotopic Mass345.1607901 g/mol
Topological Polar Surface Area30.3 Ų
Heavy Atom Count24
Formal Charge0
Complexity344
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

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


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Bal Pharma

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PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"351.3","totalValueFC":"9839.7","currency":"EUR","unitRateINR":"32807.3","date":"09-May-2024","totalValueINR":"820183","totalValueInUsd":"9839.7","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"3401165","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTA MARIA","supplierAddress":"D.D NOVO MESTO SMARJESKA CESTA 6 8501 NOVO MESTOSDNF Slovenia","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725215400,"product":"BENZYDAMINE HYDROCHLORIDE (100114)","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"INOVA PHARMACEUTICALS","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"170","totalValueFC":"2304.5","currency":"AUD","unitRateINR":"9656","date":"02-Sep-2024","totalValueINR":"193120","totalValueInUsd":"2304.5","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"5375429","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"UNIT 04-01 MILLENIA TOWER SINGAPORE SDNF SDNF Singapore Singapore","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725215400,"product":"BENZYDAMINE HYDROCHLORIDE (100114)","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"INOVA PHARMACEUTICALS","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"35.00","actualQuantity":"35","unit":"KGS","unitRateFc":"170","totalValueFC":"4032.9","currency":"AUD","unitRateINR":"9656","date":"02-Sep-2024","totalValueINR":"337960","totalValueInUsd":"4032.9","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"5375429","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"UNIT 04-01 MILLENIA TOWER SINGAPORE SDNF SDNF Singapore Singapore","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725215400,"product":"BENZYDAMINE HYDROCHLORIDE (100114)","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"INOVA PHARMACEUTICALS","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"45.00","actualQuantity":"45","unit":"KGS","unitRateFc":"170","totalValueFC":"5185.1","currency":"AUD","unitRateINR":"9656","date":"02-Sep-2024","totalValueINR":"434520","totalValueInUsd":"5185.1","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"5375429","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"UNIT 04-01 MILLENIA TOWER SINGAPORE SDNF SDNF Singapore Singapore","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725215400,"product":"BENZYDAMINE HYDROCHLORIDE (100114)","address":"NEELAM CENTRE, B WING, 4TH FLOOR","city":"MUMBAI,MAHARASHTRA","supplier":"INOVA PHARMACEUTICALS","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"170","totalValueFC":"2304.5","currency":"AUD","unitRateINR":"9656","date":"02-Sep-2024","totalValueINR":"193120","totalValueInUsd":"2304.5","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"5375429","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"UNIT 04-01 MILLENIA TOWER SINGAPORE SDNF SDNF Singapore Singapore","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728239400,"product":"BENZYDAMINE HYDROCHLORIDE - (MATERIAL NO.10114)","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"INOVA PHARMACEUTICALS","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"170","totalValueFC":"5953.2","currency":"AUD","unitRateINR":"10004.5","date":"07-Oct-2024","totalValueINR":"500225","totalValueInUsd":"5953.2","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"5996215","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"TE LTD ONE TEMASEK AVENUE UNIT 04-0 1 MILENIA TOWER SINGAPORE 039192 SDNF SINGAPORE","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"}]
22-Jan-2021
06-Feb-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDF Dossiers

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01

Benzydamine Hydrochloride

Brand Name : THROFLAM-CO

Dosage Form : MOW

Dosage Strength : 22.5mg/15 ml

Packaging : 200X1mg/15 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Benzydamine Hydrochloride

Brand Name : Throflam-Co

Dosage Form : SPO

Dosage Strength : 22.5mg/15ml

Packaging : 30X1mg/15ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

03

Benzydamine Hydrochloride

Brand Name : Throflam

Dosage Form : MOW

Dosage Strength : 22.5mg/15ml

Packaging : 200X1mg/15ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

04

Benzydamine Hydrochloride

Brand Name : Throflam

Dosage Form : SPO

Dosage Strength : 22.5mg/15ml

Packaging : 30X1mg/15ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

05

Humanis

Turkey
Arvo
Not Confirmed
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Humanis

Turkey
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Arvo
Not Confirmed

Chlorhexidine; Benzydamine Hydrochloride

Brand Name : Andorex

Dosage Form : Gargle

Dosage Strength : 18MG; 22.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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06

Arvo
Not Confirmed
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Arvo
Not Confirmed

Benzydamine hydrochloride

Brand Name : Andolex Analgesic Lozenges

Dosage Form : LOZ

Dosage Strength : 3mg

Packaging : 24X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Arvo
Not Confirmed
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Arvo
Not Confirmed

Benzydamine hydrochloride

Brand Name : Norflex Gel

Dosage Form : GEL

Dosage Strength : 3g/100g

Packaging : 30X1g/100g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Arvo
Not Confirmed
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Arvo
Not Confirmed

Benzydamine Hydrochloride; Pholcodine; Cetylpyridinium

Brand Name :

Dosage Form : Lozenge

Dosage Strength : 1.5MG; 5.5MG; 1.33MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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09

Arvo
Not Confirmed
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Arvo
Not Confirmed

BENZYDAMINE HYDROCHLORIDE

Brand Name : ODAN-BENZYDAMINE

Dosage Form : MOUTHWASH/GARGLE

Dosage Strength : 0.15%/W/V

Packaging : 250ML

Approval Date :

Application Number : 2463105

Regulatory Info : Prescription

Registration Country : Canada

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10

Pharma Dynamics

South Africa
Arvo
Not Confirmed
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Pharma Dynamics

South Africa
arrow
Arvo
Not Confirmed

Benzydamine hydrochloride

Brand Name : Gesoral Oral Spray

Dosage Form : SPO

Dosage Strength : 22.5mg/15ml

Packaging : 30X1mg/15ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Europe

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01

ANGELINI SpA

Italy
Arvo
Not Confirmed
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ANGELINI SpA

Italy
arrow
Arvo
Not Confirmed

Benzydamine Hydrochloride

Brand Name : Off

Dosage Form :

Dosage Strength : Gtt Os 30 Ml 3%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

ANGELINI SpA

Italy
Arvo
Not Confirmed
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ANGELINI SpA

Italy
arrow
Arvo
Not Confirmed

Benzydamine Hydrochloride

Brand Name : Off

Dosage Form :

Dosage Strength : 30 Conf 50 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

ANGELINI SpA

Italy
Arvo
Not Confirmed
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ANGELINI SpA

Italy
arrow
Arvo
Not Confirmed

Benzydamine Hydrochloride

Brand Name : Pink-Off

Dosage Form :

Dosage Strength : Cream Vag 30 G + 6 Applic  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

Farmak JSC

Ukraine

Benzydamine Hydrochloride

Brand Name : Zipelor Forte

Dosage Form : Oromucosal Spray

Dosage Strength : 3MG/ML

Packaging : 15ML, 30ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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05

Farmak JSC

Ukraine

Benzydamine Hydrochloride

Brand Name : Zipelor

Dosage Form : Oromucosal Spray

Dosage Strength : 1.5MG/ML

Packaging : 15ML, 30ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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06

Arvo
Not Confirmed
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Arvo
Not Confirmed

Cetylpyridinium; Benzydamine Hydrochloride; Lidocaine

Brand Name :

Dosage Form : Lozenges

Dosage Strength : 2MG; 0.5MG; 3MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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07

Meda AB

Country
Arvo
Not Confirmed
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Meda AB

Country
arrow
Arvo
Not Confirmed

bensydaminhydroklorid

Brand Name : Andolex

Dosage Form : MOUTHWASH

Dosage Strength : 1.5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Meda OTC AB

Country
Arvo
Not Confirmed
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Meda OTC AB

Country
arrow
Arvo
Not Confirmed

bensydaminhydroklorid

Brand Name : Zyx orange & honey

Dosage Form : LOZENGE

Dosage Strength : 3 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

Meda OTC AB

Country
Arvo
Not Confirmed
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Meda OTC AB

Country
arrow
Arvo
Not Confirmed

bensydaminhydroklorid

Brand Name : Zyx lemon

Dosage Form : LOZENGE

Dosage Strength : 3 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

Meda OTC AB

Country
Arvo
Not Confirmed
arrow

Meda OTC AB

Country
arrow
Arvo
Not Confirmed

bensydaminhydroklorid

Brand Name : Zyx eucalyptus

Dosage Form : LOZENGE

Dosage Strength : 3 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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ABOUT THIS PAGE

Looking for 132-69-4 / Benzydamine API manufacturers, exporters & distributors?

Benzydamine manufacturers, exporters & distributors 1

59

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

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

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

API | Excipient name

Benzydamine

Synonyms

132-69-4, Benzydamine hcl, Benzidamine hydrochloride, Benzindamine hydrochloride, Tantum, Benzydamine (hydrochloride)

Cas Number

132-69-4

Unique Ingredient Identifier (UNII)

K2GI407R4Q

About Benzydamine

A benzyl-indazole having analgesic, antipyretic, and anti-inflammatory effects. It is used to reduce post-surgical and post-traumatic pain and edema and to promote healing. It is also used topically in treatment of RHEUMATIC DISEASES and INFLAMMATION of the mouth and throat.

Indolin Manufacturers

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

Indolin Suppliers

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

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

Indolin CEP

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

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

Indolin WC

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

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

Indolin GMP

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

Indolin CoA

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

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

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