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    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
    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 Hydrochloride

    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 Weight 538.1 g/mol
    Molecular Formula C32H40ClNO4
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count10
    Exact Mass537.2645865 g/mol
    Monoisotopic Mass537.2645865 g/mol
    Topological Polar Surface Area81 Ų
    Heavy Atom Count38
    Formal Charge0
    Complexity678
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameAllegra
    PubMed HealthFexofenadine/Pseudoephedrine (By mouth)
    Drug ClassesAntihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination
    Drug LabelFexofenadine 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 IngredientFexofenadine hydrochloride
    Dosage FormSuspension
    RouteOral
    Strength30mg/5ml
    Market StatusPrescription
    CompanySanofi Aventis Us

    2 of 4  
    Drug NameFexofenadine hydrochloride
    Drug LabelFexofenadine 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 IngredientFexofenadine hydrochloride
    Dosage FormTablet; Suspension
    Routeoral; Oral
    Strength180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml
    Market StatusTentative Approval; Prescription
    CompanyRanbaxy; Aurolife Pharma; Actavis Mid Atlantic; Teva; Dr Reddys Labs; Sandoz; Mylan; Barr

    3 of 4  
    Drug NameAllegra
    PubMed HealthFexofenadine/Pseudoephedrine (By mouth)
    Drug ClassesAntihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination
    Drug LabelFexofenadine 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 IngredientFexofenadine hydrochloride
    Dosage FormSuspension
    RouteOral
    Strength30mg/5ml
    Market StatusPrescription
    CompanySanofi Aventis Us

    4 of 4  
    Drug NameFexofenadine hydrochloride
    Drug LabelFexofenadine 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 IngredientFexofenadine hydrochloride
    Dosage FormTablet; Suspension
    Routeoral; Oral
    Strength180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml
    Market StatusTentative Approval; Prescription
    CompanyRanbaxy; 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]

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Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707762600,"product":"FEXOFENADINE HYDROCHLORIDE (RE-IMPORT AFTER REJECTION)","address":"SCO.850, SHIVALIK ENCLAVE, NAC,","city":"CHANDIGARH.","supplier":"SUMMIT PHARMACEUTICALS INTERNATIONAL CORPORATION","supplierCountry":"INDIA","foreign_port":"OSAKA","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"269.17","actualQuantity":"269.17403","unit":"KGS","unitRateFc":"273","totalValueFC":"77167.5","currency":"USD","unitRateINR":"23787.1","date":"13-Feb-2024","totalValueINR":"6402875.84","totalValueInUsd":"77167.5","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"2121945","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"OSAKA","supplierAddress":"1-2-2,HITOTSUBASHI CHIYODA-KU TOKYO100-0003 Tokyo, , JAPANSDNF JAPAN","customerAddress":"SCO.850, SHIVALIK ENCLAVE, NAC,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738521000,"product":"FEXOFENADINE HYDROCHLORIDE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"225.00","actualQuantity":"225","unit":"KGS","unitRateFc":"109.1","totalValueFC":"24579.1","currency":"USD","unitRateINR":"9500","date":"03-Feb-2025","totalValueINR":"2137500","totalValueInUsd":"24579.1","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8152684","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738521000,"product":"FEXOFENADINE HYDROCHLORIDE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"109.1","totalValueFC":"32772.2","currency":"USD","unitRateINR":"9500","date":"03-Feb-2025","totalValueINR":"2850000","totalValueInUsd":"32772.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8152684","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738780200,"product":"FEXOFENADINE HYDROCHLORIDE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"2999.55","actualQuantity":"2999.55","unit":"KGS","unitRateFc":"109.1","totalValueFC":"327672.3","currency":"USD","unitRateINR":"9500","date":"06-Feb-2025","totalValueINR":"28495725","totalValueInUsd":"327672.3","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8198500","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"FEXOFENADINE HYDROCHLORIDE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"964.99","actualQuantity":"964.99","unit":"KGS","unitRateFc":"108.3","totalValueFC":"105416","currency":"USD","unitRateINR":"9500","date":"24-Feb-2025","totalValueINR":"9167405","totalValueInUsd":"105416","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8541216","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"FEXOFENADINE HYDROCHLORIDE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"1257.08","actualQuantity":"1257.08","unit":"KGS","unitRateFc":"108.3","totalValueFC":"137324","currency":"USD","unitRateINR":"9500","date":"24-Feb-2025","totalValueINR":"11942260","totalValueInUsd":"137324","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8541216","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740767400,"product":"FEXOFENADINE HYDROCHLORIDE USP FORM A FEXOFENADINE HYDROCHLORIDE USP FORM A","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"DIPHARMA FRANCIS SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"550.00","actualQuantity":"550","unit":"KGS","unitRateFc":"1262.2","totalValueFC":"703298.3","currency":"EURO","unitRateINR":"110760","date":"01-Mar-2025","totalValueINR":"60918000","totalValueInUsd":"703298.3","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"8640161","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA ORIGGIO, 23 21042 CARONNO PERTUSELLA (VA) ITALY IT","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API 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Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745001000,"product":"FEXOFENADINE HYDROCHLORIDE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"425.00","actualQuantity":"425","unit":"KGS","unitRateFc":"110","totalValueFC":"47166.1","currency":"USD","unitRateINR":"9500","date":"19-Apr-2025","totalValueINR":"4037500","totalValueInUsd":"47166.1","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"9580985","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API 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    01-Jan-2022
    29-Apr-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SUSPENSION;ORAL - 30MG/5ML

    USFDA APPLICATION NUMBER - 201373

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

    USFDA APPLICATION NUMBER - 20786

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    DOSAGE - TABLET;ORAL - 180MG

    USFDA APPLICATION NUMBER - 20872

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    DOSAGE - TABLET;ORAL - 30MG **Federal Registe...DOSAGE - TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20872

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    DOSAGE - TABLET;ORAL - 60MG

    USFDA APPLICATION NUMBER - 20872

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

    USFDA APPLICATION NUMBER - 21704

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 30MG

    USFDA APPLICATION NUMBER - 21909

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    DOSAGE - SUSPENSION;ORAL - 30MG/5ML

    USFDA APPLICATION NUMBER - 21963

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    ABOUT THIS PAGE

    Looking for 153439-40-8 / Fexofenadine Hydrochloride API manufacturers, exporters & distributors?

    Fexofenadine Hydrochloride manufacturers, exporters & distributors 1

    75

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

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

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

    API | Excipient name

    Fexofenadine Hydrochloride

    Synonyms

    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

    Cas Number

    153439-40-8

    Unique Ingredient Identifier (UNII)

    2S068B75ZU

    About Fexofenadine Hydrochloride

    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).

    Fexofenadine HCl Manufacturers

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

    Fexofenadine HCl Suppliers

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

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

    Fexofenadine HCl USDMF

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

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

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

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

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

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

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

    Fexofenadine HCl CEP

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

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

    Fexofenadine HCl WC

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

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

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

    Finished drug products

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

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

    Fexofenadine HCl GMP

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

    Fexofenadine HCl CoA

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

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

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