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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
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, (+-)-
| Molecular Weight | 538.1 g/mol |
|---|---|
| Molecular Formula | C32H40ClNO4 |
| 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 Ų |
| 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 |
| 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 |
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.)
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DMF Review : Reviewed
Rev. Date : 2014-07-15
Pay. Date : 2014-06-27
DMF Number : 23070
Submission : 2009-08-10
Status : Active
Type : II
Certificate Number : CEP 2009-160 - Rev 04
Issue Date : 2024-07-17
Type : Chemical
Substance Number : 2280
Status : Valid
Registration Number : 229MF10083
Registrant's Address : B-4,IDA,Gandhinagar,Hyderabad-500037,Telangana,INDIA
Initial Date of Registration : 2017-04-11
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NDC Package Code : 51686-0001
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End Marketing Date : 2025-12-31
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Registration Date : 2023-09-06
Registration Number : 20220324-209-J-1154(A)
Manufacturer Name : M/S.Virupaksha Organics Limited UNIT-I
Manufacturer Address : Sy.No. 10, Gaddapothram Village, Jinnaram Mandal, Sangareddy District - 502 319, Telangana, India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 2009-297 - Rev 03
Issue Date : 2021-12-09
Type : Chemical
Substance Number : 2280
Status : Valid
Registration Number : 302MF10017
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Initial Date of Registration : 2020-01-31
Latest Date of Registration : --
NDC Package Code : 82348-104
Start Marketing Date : 1997-12-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-04-23
Registration Number : 20210423-209-J-951
Manufacturer Name : EUROAPI Germany GmbH
Manufacturer Address : Brüningstraße 50, D711, D712, D721, D725, D731, D743, D770, E610, E614, 65926, Frankfurt am Main, Germany
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Suanfarma, at the Core of a Better Life.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-12
Pay. Date : 2020-12-04
DMF Number : 15757
Submission : 2001-12-05
Status : Active
Type : II
Certificate Number : R0-CEP 2021-067 - Rev 00
Issue Date : 2023-07-06
Type : Chemical
Substance Number : 2280
Status : Valid
Registration Number : 302MF10124
Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA
Initial Date of Registration : 2020-10-05
Latest Date of Registration : --
Date of Issue : 2022-06-08
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043Amended
Address of the Firm :
Registrant Name : Sangjin Corporation
Registration Date : 2022-10-06
Registration Number : 20221006-209-J-1373
Manufacturer Name : Dr. Reddy's Laboratories Ltd.
Manufacturer Address : Peddadevulapalli Village, Tripuraram Mandal, Nalgonda District, Telangana State, India - 508207
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Jai Radhe Sales is your partner for all your sourcing needs.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
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Certificate Number : CEP 2009-160 - Rev 04
Status : Valid
Issue Date : 2024-07-17
Type : Chemical
Substance Number : 2280
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 2009-297 - Rev 03
Status : Valid
Issue Date : 2021-12-09
Type : Chemical
Substance Number : 2280
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Fexofenadine Hydrochloride, Form-I
Certificate Number : R0-CEP 2021-067 - Rev 00
Status : Valid
Issue Date : 2023-07-06
Type : Chemical
Substance Number : 2280
Certificate Number : CEP 2018-101 - Rev 01
Status : Valid
Issue Date : 2024-02-23
Type : Chemical
Substance Number : 2280
Certificate Number : R0-CEP 2010-218 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2014-07-03
Type : Chemical
Substance Number : 2280
Certificate Number : CEP 2012-278 - Rev 03
Status : Valid
Issue Date : 2024-03-12
Type : Chemical
Substance Number : 2280
Certificate Number : R1-CEP 2015-256 - Rev 00
Status : Valid
Issue Date : 2021-09-16
Type : Chemical
Substance Number : 2280
Certificate Number : R1-CEP 2008-247 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2015-06-09
Type : Chemical
Substance Number : 2280
Certificate Number : CEP 2008-226 - Rev 03
Status : Valid
Issue Date : 2024-08-05
Type : Chemical
Substance Number : 2280
Fexofenadine Hydrochloride, Process-II
Certificate Number : CEP 2022-420 - Rev 01
Status : Valid
Issue Date : 2024-08-01
Type : Chemical
Substance Number : 2280
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Average Price (USD/KGS) |
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Drugs in Development
Details:
LTL Pharma will take over the Japanese marketing authorization (MA) of Sanofi’s anti-allergic medicine Diregura (fexofenadine + pseudoephedrine).
Lead Product(s): Fexofenadine Hydrochloride,Pseudoephedrine
Therapeutic Area: Immunology Brand Name: Diregura
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: LTL Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 04, 2020
Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : LTL Pharma
Deal Size : Undisclosed
Deal Type : Collaboration
LTL Pharma to Take Over Sanofi’s Diregura in Japan
Details : LTL Pharma will take over the Japanese marketing authorization (MA) of Sanofi’s anti-allergic medicine Diregura (fexofenadine + pseudoephedrine).
Brand Name : Diregura
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 04, 2020
Details:
Allegra-D (fexofenadine) is an over-the-counter oral antihistamine and nasal decongestant for the temporary relief of nasal and sinus congestion due to colds or allergies.
Lead Product(s): Fexofenadine Hydrochloride,Pseudoephedrine
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Allegra-D
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2022
Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dr. Reddy’s Announces the First-to-Market Launch of Over-the-Counter, Store-Brand Equivalent of ...
Details : Allegra-D (fexofenadine) is an over-the-counter oral antihistamine and nasal decongestant for the temporary relief of nasal and sinus congestion due to colds or allergies.
Brand Name : Allegra-D
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 22, 2022
Details:
Results from a recent pilot study showed that SJP-001, comprising a combination of naproxen and fexofenadine was significantly more effective in reducing alcohol hangover severity than placebo.
Lead Product(s): Naproxen,Fexofenadine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: SJP-001
Study Phase: IND EnablingProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2022
Lead Product(s) : Naproxen,Fexofenadine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Alcohol Hangover Treatments and the Classification for Treating Hangovers as a Disease
Details : Results from a recent pilot study showed that SJP-001, comprising a combination of naproxen and fexofenadine was significantly more effective in reducing alcohol hangover severity than placebo.
Brand Name : SJP-001
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 17, 2022
Details:
Newly acquired novel psychedelic molecules diversify Cybin’s development portfolio, providing access to multiple future indications. -Adelia leadership bring extensive clinical and commercialization experience of major drugs, including Allegra, Sabril, Anzemet , and Vaniqa.
Lead Product(s): Fexofenadine Hydrochloride
Therapeutic Area: Immunology Brand Name: Allegra
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: CYBIN
Deal Size: $15.75 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 14, 2020
Lead Product(s) : Fexofenadine Hydrochloride
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : CYBIN
Deal Size : $15.75 million
Deal Type : Acquisition
Details : Newly acquired novel psychedelic molecules diversify Cybin’s development portfolio, providing access to multiple future indications. -Adelia leadership bring extensive clinical and commercialization experience of major drugs, including Allegra, Sabril,...
Brand Name : Allegra
Molecule Type : Small molecule
Upfront Cash : Undisclosed
December 14, 2020
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
CAS Number : 115-46-8
End Use API : Fexofenadine Hydrochloride
About The Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermedia...
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
CAS Number : 38861-78-8
End Use API : Fexofenadine Hydrochloride
About The Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermedia...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Alpha,alpha-Diphenyl-4-piperidinomethanol
CAS Number : 115-46-8
End Use API : Fexofenadine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Methyl 2-(4-(4-chlorobutanoyl)phenyl)-2-methylprop...
CAS Number : 154477-54-0
End Use API : Fexofenadine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Methyl 4-[4-[4-hydroxydiphenylmethyl)-1-piperidin...
CAS Number : 154477-55-1
End Use API : Fexofenadine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-(4-(Cyclopropanecarboyl)Phenyl)-2-Methylpropanoi...
CAS Number : 162096-54-0
End Use API : Fexofenadine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
METHYL 2-(4-(4-CHLOROBUTANOYL)PHENYL)-2- METHYLPRO...
CAS Number : 154477-54-0
End Use API : Fexofenadine Hydrochloride
About The Company : Amara Labs Pvt Ltd is a WHO-GMP certified manufacturing company wholly owned by a team of technocrats with working experience of more than 20 years in Multi-Nat...
METHYL 2-(4-(4-4-(HYDROXYDIPHENYLMETHYL)-1- PIPERI...
CAS Number : 154477-55-1
End Use API : Fexofenadine Hydrochloride
About The Company : Amara Labs Pvt Ltd is a WHO-GMP certified manufacturing company wholly owned by a team of technocrats with working experience of more than 20 years in Multi-Nat...
2-Methyl-2-phenylpropanoic acid
CAS Number : 826-55-1
End Use API : Fexofenadine Hydrochloride
About The Company : Founded in 1986, Kekule has developed from a manufacturer of few molecules to a preferred vendor for many complex molecules requiring multistage synthesis. Work...
2-[4-(4-Chlorobutanoyl)phenyl]-2-Methyl propionic ...
CAS Number : 154477-54-0
End Use API : Fexofenadine Hydrochloride
About The Company : Keminntek Laboratories is a Hyderabad (India) based Contract Research Organization in Pharmaceutical sector in specific Pharmaceutical Intermediates, Speciality...
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 120MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 180MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-USP
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 120MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-USP
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-USP
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 180MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-USP
Registration Country : India
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Allegra
Dosage Form : FILM COATED PILL
Dosage Strength : 120 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Fexofenadine
Dosage Form : Fexofenadine 180Mg 20 Joined' Oral Use
Dosage Strength : 20 cpr riv 180 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Fexofenadine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 120mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Fexofenadine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 180mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Canada
Brand Name : ALLEGRA 12 HOUR
Dosage Form : TABLET
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number : 2231462
Regulatory Info :
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Australia
Brand Name : Telfast
Dosage Form : tablet
Dosage Strength : 60 mg
Packaging : 20
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Brand Name : FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG;120MG
Approval Date : 2014-11-18
Application Number : 76667
RX/OTC/DISCN : OTC
RLD : No
TE Code :
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Brand Name : FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG;120MG
Approval Date : 2022-05-31
Application Number : 215434
RX/OTC/DISCN : OTC
RLD : No
TE Code :
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code :
Brand Name : FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 60MG
Approval Date : 2019-10-18
Application Number : 211075
RX/OTC/DISCN : OTC
RLD : No
TE Code :
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code :
Brand Name : FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 180MG
Approval Date : 2019-10-18
Application Number : 211075
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : CHILDRENS ALLEGRA ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2011-01-24
Application Number : 20872
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CHILDRENS ALLEGRA HIVES
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2011-01-24
Application Number : 201373
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 60MG
Approval Date : 2015-09-16
Application Number : 204507
RX/OTC/DISCN : OTC
RLD : No
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Allegra
Dosage Form : FILM COATED PILL
Dosage Strength : 120 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Telfast
Dosage Form : FILM COATED PILL
Dosage Strength : 180 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Fexofenadine
Dosage Form : Fexofenadine 120Mg 20 Joined' Oral Use
Dosage Strength : 20 cpr riv 120 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Telfast
Dosage Form : Fexofenadine 120Mg 20 Joined' Oral Use
Dosage Strength : 20 cpr riv 120 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Telfast
Dosage Form : Fexofenadine 180Mg 20 Joined' Oral Use
Dosage Strength : 20 cpr riv 180 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Telfast
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 180 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Telfast
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 180 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Fexofenadine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 120mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Fexofenadine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 180mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Fexofenadine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 180mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Canada
Brand Name : ALLEGRA-D
Dosage Form : TABLET (IMMEDIATE AND EXTENDED RELEASE)
Dosage Strength : 60MG
Packaging : 10/20/30
Approval Date :
Application Number : 2239853
Regulatory Info :
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Canada
Brand Name : ALLEGRA 12 HOUR
Dosage Form : TABLET
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number : 2231462
Regulatory Info :
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Canada
Brand Name : ALLEGRA 24 HOUR
Dosage Form : TABLET
Dosage Strength : 120MG
Packaging :
Approval Date :
Application Number : 2242819
Regulatory Info :
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Canada
Brand Name : ALLEGRA HIVES
Dosage Form : TABLET
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number : 2521245
Regulatory Info :
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SUSPENSION;ORAL - 30MG/5ML
USFDA APPLICATION NUMBER - 201373
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
USFDA APPLICATION NUMBER - 20786
DOSAGE - TABLET;ORAL - 180MG
USFDA APPLICATION NUMBER - 20872
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
DOSAGE - TABLET;ORAL - 60MG
USFDA APPLICATION NUMBER - 20872
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
USFDA APPLICATION NUMBER - 21704
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
USFDA APPLICATION NUMBER - 21909
DOSAGE - SUSPENSION;ORAL - 30MG/5ML
USFDA APPLICATION NUMBER - 21963
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Fillers, Diluents & Binders
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DATA COMPILATION #PharmaFlow
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Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2030-08-02
US Patent Number : 8933097
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 201373
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-08-02
Patent Expiration Date : 2030-08-02
US Patent Number : 8933097
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 201373
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-08-02
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Health Canada Patents
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2013-08-03
Date Granted : 2001-02-06
Brand Name : ALLEGRA
Patent Number : 2141572
Filing Date : 1993-08-03
Strength per Unit : 60 mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-08-03
Date Granted : 2001-02-06
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2013-08-03
Date Granted : 2001-02-06
Brand Name : ALLEGRA 12 HOUR
Patent Number : 2141572
Filing Date : 1993-08-03
Strength per Unit : 60 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-08-03
Date Granted : 2001-02-06
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2013-08-03
Date Granted : 2001-02-06
Brand Name : ALLEGRA 24 HOUR
Patent Number : 2141572
Filing Date : 1993-08-03
Strength per Unit : 120 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-08-03
Date Granted : 2001-02-06
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2013-04-06
Date Granted : 1999-06-29
Brand Name : ALLEGRA
Patent Number : 2134211
Filing Date : 1993-04-06
Strength per Unit : 60 mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-04-06
Date Granted : 1999-06-29
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2016-01-26
Date Granted : 2002-04-02
Brand Name : ALLEGRA
Patent Number : 2213700
Filing Date : 1996-01-26
Strength per Unit : 60 mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2016-01-26
Date Granted : 2002-04-02
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2018-07-21
Date Granted : 2004-07-13
Brand Name : ALLEGRA
Patent Number : 2301267
Filing Date : 1998-07-21
Strength per Unit : 60 mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2018-07-21
Date Granted : 2004-07-13
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2015-04-28
Date Granted : 2012-04-17
Brand Name : ALLEGRA
Patent Number : 2585705
Filing Date : 1995-04-28
Strength per Unit : 60 mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2015-04-28
Date Granted : 2012-04-17
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2013-04-06
Date Granted : 1999-06-29
Brand Name : ALLEGRA 12 HOUR
Patent Number : 2134211
Filing Date : 1993-04-06
Strength per Unit : 60 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2013-04-06
Date Granted : 1999-06-29
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2016-01-26
Date Granted : 2002-04-02
Brand Name : ALLEGRA 12 HOUR
Patent Number : 2213700
Filing Date : 1996-01-26
Strength per Unit : 60 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2016-01-26
Date Granted : 2002-04-02
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2018-07-21
Date Granted : 2004-07-13
Brand Name : ALLEGRA 12 HOUR
Patent Number : 2301267
Filing Date : 1998-07-21
Strength per Unit : 60 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2018-07-21
Date Granted : 2004-07-13
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
EDQM
CAS Number : N/A
Quantity Per Vial : 5 mg
Sale Unit : 1
Order Code : Y0000753
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : N/A
Quantity Per Vial : 0.01 mg
Sale Unit : 1
Order Code : Y0000752
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : N/A
Quantity Per Vial : 5 mg
Sale Unit : 1
Order Code : Y0000751
Batch No : 2
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : 153439-40-8
Quantity Per Vial : 60 mg
Sale Unit : 1
Order Code : Y0000789
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]USP
Fexofenadine Related Compound C (15 mg) ((+/-...
CAS Number : N/A
Quantity Per Vial :
Price ($) : 805
Catalog Number : 1270446
Current Lot : R032J0
Previous Lot : G0I059 (30-SEP-2016)
NDC Code :
Fexofenadine Hydrochloride (200 mg)
CAS Number : 153439-40-8
Quantity Per Vial :
Price ($) : 230
Catalog Number : 1270377
Current Lot : R032H0
Previous Lot : G0K308 (28-FEB-2017)
NDC Code :
Fexofenadine (200 mg) (2-(4-{1-Hydroxy-4-[4-(...
CAS Number : 885946-90-7
Quantity Per Vial :
Price ($) : 340
Catalog Number : 1270363
Current Lot : F074R0
Previous Lot :
NDC Code :
ANALYTICAL
BioAnalytical Methods
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Analytical Methods
Product Code : TPH12S05-2546WT
Classification : DrugsC Metabolites
Product Characteristics : F130218A
Category :
Description :
Product Code : TA12S05-1046WT
Classification : DrugsC Metabolites
Product Characteristics : U110519C
Category :
Description :
Product Code : TPH12S05-2546WT
Classification : DrugsC Metabolites
Product Characteristics : F130218B
Category :
Description :
Product Code : TPH12S05-2546WT
Classification : DrugsC Metabolites
Product Characteristics : F130218D
Category :
Description :
Product Code : TPH12S05-2546WT
Classification : DrugsC Metabolites
Product Characteristics : F130218C
Category :
Description :
ABOUT THIS PAGE
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.
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.
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.
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.
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).
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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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Fexofenadine API and other APIs are published in this directory by the FDA.
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.
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 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.
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).
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