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Chemistry

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Also known as: 522-51-0, Dequalinium dichloride, Dequafungan, Dekamin, Decamine, Phylletten
Molecular Formula
C30H40Cl2N4
Molecular Weight
527.6  g/mol
InChI Key
LTNZEXKYNRNOGT-UHFFFAOYSA-N
FDA UNII
XYS8INN1I6

Dequalinium Chloride
A topical bacteriostat that is available as various salts. It is used in wound dressings and mouth infections and may also have antifungal action, but may cause skin ulceration.
1 2D Structure

Dequalinium Chloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[10-(4-amino-2-methylquinolin-1-ium-1-yl)decyl]-2-methylquinolin-1-ium-4-amine;dichloride
2.1.2 InChI
InChI=1S/C30H38N4.2ClH/c1-23-21-27(31)25-15-9-11-17-29(25)33(23)19-13-7-5-3-4-6-8-14-20-34-24(2)22-28(32)26-16-10-12-18-30(26)34;;/h9-12,15-18,21-22,31-32H,3-8,13-14,19-20H2,1-2H3;2*1H
2.1.3 InChI Key
LTNZEXKYNRNOGT-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=[N+](C2=CC=CC=C2C(=C1)N)CCCCCCCCCC[N+]3=C(C=C(C4=CC=CC=C43)N)C.[Cl-].[Cl-]
2.2 Other Identifiers
2.2.1 UNII
XYS8INN1I6
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Acetate, Dequalinium

2. Chloride, Dequalinium

3. Decamine

4. Dequadin

5. Dequalinium

6. Dequalinium Acetate

7. Dequalinium Di-10-undecenoate

8. Dequalinium Diacetate

9. Dequalinium Dibromide

10. Dequalinium Dichloride

11. Dequalinium Diiodide

12. Dequalinium Diundecenoate

13. Di-10-undecenoate, Dequalinium

14. Diacetate, Dequalinium

15. Dibromide, Dequalinium

16. Dichloride, Dequalinium

17. Diiodide, Dequalinium

18. Diundecenoate, Dequalinium

19. Dynexan Mhp

20. Dynexan-mhp

21. Evazol

22. Fluomycin

23. Gargilon

24. Gurgellsung Ratiopharm

25. Gurgellsung-ratiopharm

26. Labosept

27. Maltyl

28. Solvidont

29. Sorot

2.3.2 Depositor-Supplied Synonyms

1. 522-51-0

2. Dequalinium Dichloride

3. Dequafungan

4. Dekamin

5. Decamine

6. Phylletten

7. Danical

8. Decabis

9. Dequalinium (chloride)

10. Dequadin

11. Labosept

12. Evazol

13. Sorot

14. Baqd 10

15. Dequalinii Chloridum

16. Dekadin

17. Dequavagyn

18. Dequavet

19. Erosept

20. Grocreme

21. Oralgol

22. Polycidine

23. Rumilet

24. Sanoral

25. Sentril

26. Cloruro De Decalinio

27. Efisol

28. Ivazil

29. 1,1'-decamethylenebis(4-aminoquinaldinium Chloride)

30. Dequalin Chloride

31. Chlorure De Dequalinium

32. Nordman

33. Dequalinum Chloride

34. Xys8inn1i6

35. 1,10-decamethylene-bis(4-aminoquinaldinium Chloride)

36. Baqd-10

37. Decamethylenebis(4-aminoquinaldinium Chloride)

38. Chebi:31466

39. Gnf-pf-5483

40. Nsc-166454

41. Decaminum

42. Decosan

43. Dekuarin

44. Eriosept

45. Gorgine

46. Optipect

47. Angils

48. Vaster

49. Dynexan-mhp

50. 1,1'-(1,10-decanediyl)bis(4-amino-2-methylquinolinium) Dichloride

51. 1,1'-(decane-1,10-diyl)bis(4-amino-2-methylquinolin-1-ium) Chloride

52. Quinolinium, 1,1'-(1,10-decanediyl)bis[4-amino-2-methyl-, Dichloride

53. 1-[10-(4-amino-2-methylquinolin-1-ium-1-yl)decyl]-2-methylquinolin-1-ium-4-amine;dichloride

54. Decamine (pharmaceutical)

55. Quinolinium, 1,1'-(1,10-decanediyl)bis(4-amino-2-methyl-, Dichloride

56. Chembl121663

57. Dequalinio Cloruro

58. Dequalinio Cloruro [dcit]

59. Fluomizin

60. Dequalinii Chloridum [inn-latin]

61. Sr-01000075814

62. Ncgc00015339-02

63. Cas-522-51-0

64. Cloruro De Decalinio [inn-spanish]

65. Einecs 208-330-9

66. Unii-xys8inn1i6

67. Dequalinium Chloride [inn:ban:jan]

68. Chlorure De Dequalinium [inn-french]

69. Nsc 166454

70. Nordman (tn)

71. Quinaldinium, 1,1'-decamethylenebis(4-amino)-, Dichloride

72. Dsstox_cid_25144

73. Dsstox_rid_80700

74. Dsstox_gsid_45144

75. Schembl34043

76. Spectrum1503127

77. Dtxsid3045144

78. Dequalinium Chloride (jan/inn)

79. Hms502f14

80. Amy3365

81. Dequalinium Chloride [mi]

82. Quinaldinium, 1,1'-decamethylenebis(4-amino-, Dichloride

83. Dequalinium Chloride [inn]

84. Dequalinium Chloride [jan]

85. Hms1569m17

86. Hms1922g11

87. Hms2096m17

88. Hms3261c17

89. Hms3713m17

90. Dequalinium Chloride [inci]

91. Bcp21273

92. Hy-b0567

93. Tox21_110128

94. Tox21_500338

95. Dequalinium Chloride [mart.]

96. Mfcd00063502

97. S4066

98. Dequalinium Chloride [who-dd]

99. Akos015895242

100. Ccg-213734

101. Lp00338

102. Dequalinium Chloride For Performance Test

103. Ncgc00093777-01

104. Ncgc00093777-02

105. Ncgc00093777-03

106. Ncgc00261023-01

107. As-76177

108. Dequalinium Chloride [ep Monograph]

109. Db-052103

110. Eu-0100338

111. Ft-0603110

112. D 3768

113. D01575

114. F21484

115. A829001

116. Q5261117

117. Sr-01000075814-1

118. Sr-01000075814-3

119. Sr-01000075814-6

120. Sr-01000075814-7

121. W-105841

122. 1,1'-decamethylenebis(4-aminoquinaldinium) Dichloride

123. 1,1'-(decane-1,10-diyl)bis(4-amino-2-methylquinolinium) Chloride

124. 1,1'-decane-1,10-diylbis(4-amino-2-methylquinolinium) Dichloride

125. Deca; Dequavagyn; Nsc 166454; Nsc-166454; Nsc166454

126. Dequalinium Chloride, European Pharmacopoeia (ep) Reference Standard

127. 1,1'-(1,10-decanediyl)bis-(4-amino-2-methylquinolinium Chloride)

128. 1-[(2,4-diamino-5-pyrimidinyl)methyl]-pyridiniumbromidemonohydrobromide

129. Dequalinium Chloride For Performance Test, European Pharmacopoeia (ep) Reference Standard

130. Dequalinium Chloride, Pharmaceutical Secondary Standard; Certified Reference Material

131. Quinolinium, 1,1'-(1,10-decanediyl)bis[4-amino-2-methyl-, Chloride (1:2)

132. 1-[10-(4-amino-2-methyl-quinolin-1-ium-1-yl)decyl]-2-methyl-quinolin-1-ium-4-amine Dichloride Hydrate

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 527.6 g/mol
Molecular Formula C30H40Cl2N4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count11
Exact Mass526.2630027 g/mol
Monoisotopic Mass526.2630027 g/mol
Topological Polar Surface Area59.8 Ų
Heavy Atom Count36
Formal Charge0
Complexity532
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Infective Agents, Local

Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects. (See all compounds classified as Anti-Infective Agents, Local.)


API SUPPLIERS

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LEBSA

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CR Double-Crane Pharmaceuticals Co...

China

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Olon S.p.A

Italy

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Olon S.p.A

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CEP/COS

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R0-CEP 2019-026 - Rev 02
Valid
Chemical
2023-02-17
1413
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Certificate Number : R0-CEP 2019-026 - Rev 02

Status : Valid

Issue Date : 2023-02-17

Type : Chemical

Substance Number : 1413

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Dequalinium chloride

Registration Number : 221MF10274

Registrant's Address : Ctra. de l'Hospitalet, 34 08940 Cornella (Barcelona) SPAIN

Initial Date of Registration : 2009-12-15

Latest Date of Registration : 2020-08-05

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Dequalinium chloride

Registration Number : 219MF10363

Registrant's Address : Strada Rivoltana, km 6/7, 20090 Rodano (MI), Italy

Initial Date of Registration : 2007-12-13

Latest Date of Registration : 2007-12-13

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LEBSA

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Dequalinium Chloride

About the Company : Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning...

Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning 70 years, Lebsa has established itself as a reputable player in the global pharmaceutical market, particularly in generic API manufacturing. Headquartered in Barcelona, Spain, Lebsa exports up to 90% of its production. Lebsa's state-of-the-art facilities, located near Barcelona, feature cutting-edge technology, equipment and automated processes. Lebsa has expertise in registering APIs in countries across Europe, Canada, Taiwan, China, Russia, Brazil and Japan.
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Dequalinium Chloride

About the Company : CR Double-Crane Pharmaceuticals Co., Ltd (hereinafter referred to as CR Double-Crane) is a pharmaceuticals company with 75 years of brilliant history. Formerly known as Beijing Pha...

CR Double-Crane Pharmaceuticals Co., Ltd (hereinafter referred to as CR Double-Crane) is a pharmaceuticals company with 75 years of brilliant history. Formerly known as Beijing Pharmaceuticals Factory, the company was listed on Shanghai Stock Exchange in 1997 with Stock Code as 600062. In 2010, it was merged into China Resources (Group) Co, Ltd. which is one of the Global 500 companies and became the main manufacturer of chemical medicines under the Group. In 2012, the company was officially renamed from Beijing Double-Crane Pharmaceuticals Co., Ltd. to CR Double-Crane Pharmaceuticals Co., Ltd.
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Dequalinium Chloride

About the Company : We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (...

We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for generic and contract development and the manufacturing market, in a full cGMPs environment, following ICH Q7 compliance.
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API Reference Price

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LTD","customerCountry":"INDIA","quantity":"1.65","actualQuantity":"1.65","unit":"KGS","unitRateFc":"5975","totalValueFC":"11038.7","currency":"EUR","unitRateINR":"546982.8","date":"30-Jan-2023","totalValueINR":"902521.54","totalValueInUsd":"11038.7","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4409703","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1108, EMBASSY CENTRE, J. B. MARG, NARIMAN POINT,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696530600,"product":"DEQUALINIUM CHLORIDE 000040 2610870","address":"NO.49D, BOMMASANDRA INDUSTRIAL","city":"BANGALORE","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ADCOCK INGRAM","customerCountry":"INDIA","quantity":"0.55","actualQuantity":"0.55","unit":"KGS","unitRateFc":"5800","totalValueFC":"3420.8","currency":"EUR","unitRateINR":"517650","date":"06-Oct-2023","totalValueINR":"284707.5","totalValueInUsd":"3420.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"8165965","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STRADA RIVOLTANA KM 6\/720053 RODANO MISDNF ITALY","customerAddress":"NO.49D, BOMMASANDRA INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700764200,"product":"DEQUALINIUM CHLORIDE 000010 2610870 BATCH NO 2310001014","address":"NO.49D, BOMMASANDRA INDUSTRIAL","city":"BANGALORE","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ADCOCK INGRAM","customerCountry":"INDIA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"5800","totalValueFC":"9585.9","currency":"EUR","unitRateINR":"532150","date":"24-Nov-2023","totalValueINR":"798225","totalValueInUsd":"9585.9","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"8910179","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STRADA RIVOLTANA KM 6\/720053 RODANO MISDNF ITALY","customerAddress":"NO.49D, BOMMASANDRA INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712514600,"product":"DEQUALINIUM CHLORIDE BP","address":"28, MAHENDRA MANSION, 2ND FLOOR,","city":"MUMBAI ,MAHARASHTRA","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"APEX DRUG HOUSE","customerCountry":"INDIA","quantity":"0.97","actualQuantity":"965","unit":"GMS","unitRateFc":"8.5","totalValueFC":"9143.3","currency":"EUR","unitRateINR":"791.2","date":"08-Apr-2024","totalValueINR":"763534.33","totalValueInUsd":"9143.3","indian_port":"Bombay Air","hs_no":"29334900","bill_no":"2935533","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"Ctra.de l\\'Hospitalet 34 08940 Cornell? de Llobregat Barcelona ., , SPAIN SPAIN","customerAddress":"28, MAHENDRA MANSION, 2ND FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"DEQUALINIUM CHLORIDE","address":"1108,EMBASSY CENTRE,","city":"MUMBAI MAHARASHTRA","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MERIDIAN ENTERPRISES PVT. LTD","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"204","unit":"GMS","unitRateFc":"16.5","totalValueFC":"3794.5","currency":"EUR","unitRateINR":"1552.8","date":"26-Jun-2024","totalValueINR":"316764.72","totalValueInUsd":"3794.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4195936","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CTRA. DE l HOSPITALET, 34, 08940 CORNELLA (BARCELONA) SPAIN Barcelona,, Spain Spain","customerAddress":"1108,EMBASSY CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"DEQUALINIUM CHLORIDE","address":"1108,EMBASSY CENTRE,","city":"MUMBAI MAHARASHTRA","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MERIDIAN ENTERPRISES PVT. LTD","customerCountry":"INDIA","quantity":"2.65","actualQuantity":"2.65","unit":"KGS","unitRateFc":"6610","totalValueFC":"19813.3","currency":"EUR","unitRateINR":"624987.9","date":"22-Jul-2024","totalValueINR":"1656217.97","totalValueInUsd":"19813.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4647264","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CTRA. DE l HOSPITALET, 34, 08940 CORNELLA (BARCELONA) SPAIN Barcelona,, Spain Spain","customerAddress":"1108,EMBASSY CENTRE,"}]
03-Aug-2021
22-Jul-2024
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Number of Transactions

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

API Imports and Exports

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Drugs in Development

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Details:

Vablys® (dequalinium chloride vaginal tablets), is the first prescription antiseptic and anti-infective treatment for bacterial vaginosis in women under 55 years of age.


Lead Product(s): Dequalinium Chloride

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vablys

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 21, 2022

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Duchesnay

Canada
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Duchesnay

Canada
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Details : Vablys® (dequalinium chloride vaginal tablets), is the first prescription antiseptic and anti-infective treatment for bacterial vaginosis in women under 55 years of age.

Brand Name : Vablys

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 21, 2022

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INTERMEDIATES SUPPLIERS

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CAS Number : 16355-92-3

End Use API : Dequalinium Chloride

About The Company : At Infinium Pharmachem Pvt. Ltd., we are well focused to Iodine chemistry & this is the only core area of ours. We are working as CRAMS, but our domain is very ...

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CAS Number : 16355-92-3

End Use API : Dequalinium Chloride

About The Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom sy...

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CAS Number : 02-04-6628

End Use API : Dequalinium Chloride

About The Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom sy...

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Europe

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Farmak JSC

Ukraine
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Farmak JSC

Ukraine
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Lysozyme; Dequalinium Chloride

Brand Name : Lizak with mint and anise or with orange, or with chocolate, or with raspberry

Dosage Form : Sucking Tablet

Dosage Strength : 10MG; 0.25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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Medinova AG

Switzerland
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Medinova AG

Switzerland
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Dequalinii chloride

Brand Name : Fluomizin

Dosage Form : Vag Tabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Spirig HealthCare AG

Switzerland
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Spirig HealthCare AG

Switzerland
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Dequalinii chloridum; Tyrothricinum; Lidocaini hydrochloridum monohydricum

Brand Name : Tyroqualin

Dosage Form : Lutschtabl

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Dequalinium Chloride; Lidocaine

Brand Name :

Dosage Form : LOZENGE

Dosage Strength : 0.25MG; 1MG

Packaging : 20 Lozenges

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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Dequalinium Chloride; Lidocaine

Brand Name :

Dosage Form : SPRAY

Dosage Strength : 1.25MG; 1MG

Packaging : 30 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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Ebb Medical AB

Country
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Ebb Medical AB

Country
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dequalinium

Brand Name : Donaxyl

Dosage Form : VAGINAL TABLET

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Campus Pharma AB

Country
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Campus Pharma AB

Country
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dequalinium

Brand Name : Donaxyl

Dosage Form : VAGINAL TABLET

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Campus pharma AB

Country
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Campus pharma AB

Country
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Dequalinium Chloride

Brand Name : Donaxyl

Dosage Form : Vaginal Tablet

Dosage Strength : 10 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Canada

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DUCHESNAY INC

Canada
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DUCHESNAY INC

Canada
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DEQUALINIUM CHLORIDE

Brand Name : VABLYS

Dosage Form : VAGINAL TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2518252

Regulatory Info :

Registration Country : Canada

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DEQUALINIUM CHLORIDE

Brand Name : DEQUADIN

Dosage Form : LOZENGE

Dosage Strength : 0.25MG

Packaging :

Approval Date :

Application Number : 2100207

Regulatory Info :

Registration Country : Canada

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DEQUALINIUM CHLORIDE

Brand Name : DEQUADIN ORAL PAINT

Dosage Form : SOLUTION

Dosage Strength : 0.5%/W/V

Packaging : 25ML

Approval Date :

Application Number : 2091453

Regulatory Info :

Registration Country : Canada

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DEQUALINIUM CHLORIDE

Brand Name : DEQUADIN ORAL SPRAY

Dosage Form : SOLUTION

Dosage Strength : 0.5%/W/V

Packaging :

Approval Date :

Application Number : 2522616

Regulatory Info :

Registration Country : Canada

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South Africa

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Dequalinium Chloride

Brand Name : Dequadin Mouth Paint

Dosage Form : PAI

Dosage Strength : 0.4g

Packaging : 10X1g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

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Dequalinium Chloride; Lidocaine

Brand Name : DEBARA

Dosage Form : LOZENGE (LIMON OR PEPE...

Dosage Strength : 0.25MG; 0.03MG

Packaging : 20 LOZENGES

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Dequalinium Chloride; Lidocaine

Dosage : LOZENGE (LIMON OR PEPE...

Dosage Strength : 0.25MG; 0.03MG

Brand Name : DEBARA

Approval Date :

Application Number :

Registration Country : Turkey

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Dequalinium Chloride; Lidocaine

Brand Name : DEBARA-S

Dosage Form : SPRAY (LIMON OR PEPERM...

Dosage Strength : 1.25MG; 1MG

Packaging : 30 ML/BOTTLE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Dequalinium Chloride; Lidocaine

Dosage : SPRAY (LIMON OR PEPERM...

Dosage Strength : 1.25MG; 1MG

Brand Name : DEBARA-S

Approval Date :

Application Number :

Registration Country : Turkey

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NEWS #PharmaBuzz

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APIs

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REF. STANDARDS & IMPURITIES

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ABOUT THIS PAGE

Dequalinium Chloride Manufacturers

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

Dequalinium Chloride Suppliers

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

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

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

Dequalinium Chloride CEP

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

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

Dequalinium Chloride GMP

Dequalinium Chloride 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 Dequalinium Chloride 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 Dequalinium Chloride GMP manufacturer or Dequalinium Chloride GMP API supplier for your needs.

Dequalinium Chloride CoA

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

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

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