Find Fexofenadine Hydrochloride manufacturers, exporters & distributors on PharmaCompass

Fexofenadine

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

78 API Suppliers, 25 USDMF, 12 CEP/COS, 16 JDMF, 12 EU WC, 8 KDMF, 24 NDC API, 46 Listed Suppliers

DEVELOPMENTS

4 Drug(s) in Development

4 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

24 Suppliers

24 Suppliers

DOSSIERs // Finished Dosage Formulations

223 Dossiers, 96 FDA Orange Book, 37 Europe, 4 Canada, 5 Australia, 24 South Africa, 57 Listed Dossiers

DRUG PRODUCT COMPOSITION

SUSPENSION;ORAL - 30MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG, TABLET;ORAL - 180MG, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, TABLET, ORALLY DISINTEGRATING;ORAL - 30MG, SUSPENSION;ORAL - 30MG/5ML

SUSPENSION;ORAL - 30MG/5ML
TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
TABLET;ORAL - 180MG
TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 60MG
TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
SUSPENSION;ORAL - 30MG/5ML

RELATED EXCIPIENT COMPANIES

Suppliers, 37 Kerry, 36 BASF, 29 Roquette, 18 Microlex e.U, 18 SPI Pharma, 13 Seppic, 13 Gangwal Healthcare, 12 Actylis, 12 Sigachi Industries, 12 Gangwal Chemicals, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 Corel Pharma Chem, 8 Boai NKY Pharmaceuticals Ltd, 8 Nanjing Well Pharmaceutical, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 7 DFE Pharma, 6 Rochem International Inc, 6 Lonza Capsugel, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 5 Prachin Chemical, 5 Pharmatrans-Sanaq, 4 Vasa Pharmachem, 4 ACG Worldwide, 4 Kima Chemical, 3 Jai Radhe Sales, 3 DKSH, 3 Alcedo Pharmachem, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Pfanstiehl, 2 Pharm-RX Chemical, 2 Nanjing Bold Chemical, 2 Qualicaps, 2 Nomisma Healthcare, 2 Zhejiang Huakang Pharmaceutical, 2 Seqens, 2 Finar, 2 Vertellus, 1 Clariant, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Bioplus Life Sciences, 1 NEWEDGE Overseas, 1 Chynops Pharma, 1 Minakem, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Aeon Procare, 1 Huzhou Sunflower Pharmaceutical Co. Ltd

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 58 Coating Systems & Additives, 50 Direct Compression, 44 Disintegrants & Superdisintegrants, 36 Thickeners and Stabilizers, 36 Controlled & Modified Release, 35 Granulation, 32 Taste Masking, 31 Solubilizers, 27 Lubricants & Glidants, 26 Film Formers & Plasticizers, 23 Chewable & Orodispersible Aids, 19 Topical, 19 Parenteral, 17 Co-Processed Excipients, 9 Empty Capsules, 9 API Stability Enhancers, 6 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 2 Coloring Agents

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 35 Finished Drug Prices

MARKET PLACE

32 APIs, 2 DOSSIERS // FDF

PATENTS

2 US Patents, 14 Health Canada Patents

ANALYTICAL SOLUTION(s)

1 BioAnalytical Methods, 5 Analytical Solutions, 4 EDQM Standards, 3 USP Standards, 4 JP Standards, 6 Other Ref. Standards

DIGITAL CONTENT

4 Data Compilations & Company Tracker #PharmaFlow, 28 News

API SUPPLIERS

API Suppliers

US DMFs Filed

CEP/COS Certifications

JDMFs Filed

Other Certificates

Other Suppliers

API REF. PRICE (USD / KG)

132

API Market Place

INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

Europe

Canada

Australia

South Africa

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

587.00

FDF Market Place

EXCIPIENTS

339

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

Other Listed Suppliers

SERVICES

Also known as: 153439-40-8, Fexofenadine hcl, Allegra, Telfast, 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic acid hydrochloride, Mdl 16,455a

Molecular Formula

C₃₂H₄₀ClNO₄

Molecular Weight

538.1 g/mol

InChI Key

RRJFVPUCXDGFJB-UHFFFAOYSA-N

FDA UNII

2S068B75ZU

Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine, a carboxylated metabolic derivative of terfenadine and second generation, long-lasting selective histamine H1 receptor antagonist, with antihistaminic activity. Upon administration, fexofenadine competitively binds of peripheral H1-receptors in the gastrointestinal (GI) tract, blood vessels, and bronchial smooth muscle. This prevents binding of histamine to peripheral H1-receptors and prevents their activation. This prevents a histamine-mediated allergic reaction. Fexofenadine does not cross the blood-brain-barrier (BBB).

1 2D Structure

Fexofenadine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid;hydrochloride

2.1.2 InChI

InChI=1S/C32H39NO4.ClH/c1-31(2,30(35)36)25-17-15-24(16-18-25)29(34)14-9-21-33-22-19-28(20-23-33)32(37,26-10-5-3-6-11-26)27-12-7-4-8-13-27;/h3-8,10-13,15-18,28-29,34,37H,9,14,19-23H2,1-2H3,(H,35,36);1H

2.1.3 InChI Key

RRJFVPUCXDGFJB-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(C)(C1=CC=C(C=C1)C(CCCN2CCC(CC2)C(C3=CC=CC=C3)(C4=CC=CC=C4)O)O)C(=O)O.Cl

2.2 Other Identifiers

2.2.1 UNII

2S068B75ZU

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Allegra

2. Alpha-(4-(1-carboxy-1-methylethyl)phenyl)-4-hydroxydiphenylmethyl-1-piperidinebutanol

3. Fexofenadine

4. Mdl 16,455a

5. Mdl 16.455

6. Mdl 16455

7. Mdl-16455

8. Telfast

2.3.2 Depositor-Supplied Synonyms

1. 153439-40-8

2. Fexofenadine Hcl

3. Allegra

4. Telfast

5. 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic Acid Hydrochloride

6. Mdl 16,455a

7. 138452-21-8

8. Fexofenadine (hydrochloride)

9. Mdl 16455

10. Mdl-16455a

11. Terfenadine Carboxylate Hydrochloride

12. 2s068b75zu

13. Mdl 16455a

14. 2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanoic Acid Hydrochloride

15. 2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butyl]phenyl]-2-methylpropanoic Acid;hydrochloride

16. 153439-40-8 (hcl)

17. Dsstox_cid_28642

18. Dsstox_rid_82912

19. Dsstox_gsid_48716

20. Allegra Allergy

21. Allegra Hives

22. Smr000718798

23. Cas-153439-40-8

24. Ncgc00015453-05

25. Children's Allegra Hives

26. Fexofenidine Hydrochloride

27. Children's Allegra Allergy

28. Terfenidine

29. Altiva

30. Unii-2s068b75zu

31. Carboxyterfenadine Hydrochloride

32. Allegra Flash

33. Sr-01000075889

34. Allegra Od

35. Fexofenadine Hydrochloride [usan]

36. Fexofenadine, Hcl

37. Allegra (tn)

38. Terfenidine Carboxylate Hydrochloride

39. Mfcd00865710

40. Fexofenadine Hydrochloride [usan:usp]

41. Fexofenadina Cloridrato

42. Fexofenadine-d10 Hcl

43. Cloridrato De Fexofenadina

44. Clorhidrato De Fexofenadina

45. Chlorhydrate De Fexofenadine

46. Mdl-16455 Hydrochloride

47. Schembl40914

48. Mls001306422

49. Mls001332493

50. Mls001332494

51. Fexofenadine Impurity Standard

52. Spectrum1504179

53. Chebi:5051

54. Chembl1200618

55. Dtxsid5048716

56. Hy-b0801a

57. Fexofenadine Hydrochloride- Bio-x

58. Pharmakon1600-01504179

59. Tox21_113125

60. Nsc758678

61. S3208

62. Akos015907422

63. Tox21_113125_1

64. Ab07499

65. Ccg-213275

66. Cs-4483

67. Fexofenadine Hydrochloride (jp17/usp)

68. Fexofenadine Hydrochloride [mi]

69. Ks-1057

70. Nc00724

71. Nsc 758678

72. Nsc-758678

73. Fexofenadine Hydrochloride [jan]

74. Ncgc00015453-02

75. Ncgc00015453-08

76. Ncgc00092389-01

77. Ncgc00095906-01

78. Ncgc00095906-02

79. (+-)-p-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidino)butyl)-alpha-methylhydratropic Acid Hydrochloride

80. Ac-24745

81. Bf164454

82. Fexofenadine Hydrochloride [mart.]

83. Fexofenadine Hydrochloride [vandf]

84. Fexofenadine Hydrochloride [usp-rs]

85. Fexofenadine Hydrochloride [who-dd]

86. Fexofenadine Hydrochloride, >98% (hplc)

87. Db-043190

88. A3371

89. F0698

90. Ft-0631183

91. M-016455-o

92. Sw199568-2

93. Bim-0050472.0001

94. D00671

95. Fexofenadine Hydrochloride [orange Book]

96. Fexofenadine Hydrochloride [ep Monograph]

97. Fexofenadine Hydrochloride [usp Impurity]

98. 452f218

99. Fexofenadine Hydrochloride [usp Monograph]

100. J-505843

101. Sr-01000075889-6

102. Allegra-d Component Fexofenadine Hydrochloride

103. Q27255526

104. Fexofenadine Hydrochloride 100 Microg/ml In Acetonitrile

105. Fexofenadine Hydrochloride Component Of Allegra-d

106. Z2210694607

107. Fexofenadine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

108. Fexofenadine Hcl, Pharmaceutical Secondary Standard; Certified Reference Material

109. Fexofenadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

110. (+/-)-p-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidino)butyl)-.alpha.-methylhydratropic Acid, Hydrochloride

111. 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic Acid Hcl

112. 2-(4-{1-hydroxy-4-[4-(hydroxy-diphenyl-methyl)-piperidin-1-yl]-butyl}-phenyl)-2-methyl-propionic Acid

113. 2-(4-{1-hydroxy-4-[4-(hydroxy-diphenyl-methyl)-piperidin-1-yl]-butyl}-phenyl)-2-methyl-propionic Acid; Hydrochloride;fexofenadine Hcl

114. 4-[(4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride

115. 4-[4-[4-(hydroxydiphenylmethyl)-1-pieridinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride

116. 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride

117. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-.alpha.,.alpha.-dimethyl-, Hydrochloride, (+/-)-

118. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-alpha,alpha-dimethyl-, Hydrochloride

119. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-alpha,alpha-dimethyl-, Hydrochloride, (+-)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₃₂H₄₀ClNO₄
Molecular Weight	538.1 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	10
Exact Mass	537.2645865 g/mol
Monoisotopic Mass	537.2645865 g/mol
Topological Polar Surface Area	81 Å²
Heavy Atom Count	38
Formal Charge	0
Complexity	678
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Allegra
PubMed Health	Fexofenadine/Pseudoephedrine (By mouth)
Drug Classes	Antihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination
Drug Label	Fexofenadine hydrochloride, the active ingredient of ALLEGRA Tablets, ALLEGRA ODT and ALLEGRA Oral Suspension, is a histamine H1-receptor antagonist with the chemical name ()-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-,-dim...
Active Ingredient	Fexofenadine hydrochloride
Dosage Form	Suspension
Route	Oral
Strength	30mg/5ml
Market Status	Prescription
Company	Sanofi Aventis Us

2 of 4
Drug Name	Fexofenadine hydrochloride
Drug Label	Fexofenadine hydrochloride is a histamine H1-receptor antagonist with the chemical name (benzeneacetic acid hydrochloride. It has the following chemical structure:C32H39NO4Molecular Weight: 538.13Fexofenadine hydrochloride is a white to off-white cry...
Active Ingredient	Fexofenadine hydrochloride
Dosage Form	Tablet; Suspension
Route	oral; Oral
Strength	180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml
Market Status	Tentative Approval; Prescription
Company	Ranbaxy; Aurolife Pharma; Actavis Mid Atlantic; Teva; Dr Reddys Labs; Sandoz; Mylan; Barr

3 of 4
Drug Name	Allegra
PubMed Health	Fexofenadine/Pseudoephedrine (By mouth)
Drug Classes	Antihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination
Drug Label	Fexofenadine hydrochloride, the active ingredient of ALLEGRA Tablets, ALLEGRA ODT and ALLEGRA Oral Suspension, is a histamine H1-receptor antagonist with the chemical name ()-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-,-dim...
Active Ingredient	Fexofenadine hydrochloride
Dosage Form	Suspension
Route	Oral
Strength	30mg/5ml
Market Status	Prescription
Company	Sanofi Aventis Us

4 of 4
Drug Name	Fexofenadine hydrochloride
Drug Label	Fexofenadine hydrochloride is a histamine H1-receptor antagonist with the chemical name (benzeneacetic acid hydrochloride. It has the following chemical structure:C32H39NO4Molecular Weight: 538.13Fexofenadine hydrochloride is a white to off-white cry...
Active Ingredient	Fexofenadine hydrochloride
Dosage Form	Tablet; Suspension
Route	oral; Oral
Strength	180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml
Market Status	Tentative Approval; Prescription
Company	Ranbaxy; Aurolife Pharma; Actavis Mid Atlantic; Teva; Dr Reddys Labs; Sandoz; Mylan; Barr

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Allergic Agents

Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)

Histamine H1 Antagonists, Non-Sedating

A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]