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Chemistry

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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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MALPENSA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"1262.2","totalValueFC":"319681.1","currency":"EURO","unitRateINR":"110760","date":"01-Mar-2025","totalValueINR":"27690000","totalValueInUsd":"319681.1","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 21042 CARONNO PERTUSELLA (VA) ITALY IT","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742149800,"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":"2418.95","actualQuantity":"2418.95","unit":"KGS","unitRateFc":"108.2","totalValueFC":"265304.4","currency":"USD","unitRateINR":"9500","date":"17-Mar-2025","totalValueINR":"22980025","totalValueInUsd":"265304.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8930963","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":1742841000,"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":"1060.01","actualQuantity":"1060.01","unit":"KGS","unitRateFc":"108.8","totalValueFC":"116259.2","currency":"USD","unitRateINR":"9500","date":"25-Mar-2025","totalValueINR":"10070095","totalValueInUsd":"116259.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"9097618","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":1742841000,"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":"1357.00","actualQuantity":"1357","unit":"KGS","unitRateFc":"108.8","totalValueFC":"148832.4","currency":"USD","unitRateINR":"9500","date":"25-Mar-2025","totalValueINR":"12891500","totalValueInUsd":"148832.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"9097618","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":"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":"1188.11","actualQuantity":"1188.11","unit":"KGS","unitRateFc":"110","totalValueFC":"131855.3","currency":"USD","unitRateINR":"9500","date":"19-Apr-2025","totalValueINR":"11287045","totalValueInUsd":"131855.3","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,"}]
01-Jan-2022
30-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

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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 Manufacturers

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

Fexofenadine Suppliers

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

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

Fexofenadine USDMF

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

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

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

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

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

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

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

Fexofenadine CEP

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

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

Fexofenadine WC

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

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

Fexofenadine 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fexofenadine GMP

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

Fexofenadine CoA

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

Fexofenadine CoA mostly includes findings from lab analyses of a specific batch. For each Fexofenadine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Fexofenadine EP), Fexofenadine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fexofenadine 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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