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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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USDMF
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GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-06-27
DMF Number : 23070
Submission : 2009-08-10
Status : Active
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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DMF Number : 34645
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DMF Number : 15757
Submission : 2001-12-05
Status : Active
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
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Rev. Date : 2016-09-19
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DMF Number : 30604
Submission : 2016-08-16
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
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Submission : 2005-11-09
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
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Submission : 2005-11-09
Status : Inactive
Type : II
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Submission : 2005-09-21
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Submission : 2002-06-20
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Certificate Number : CEP 2009-160 - Rev 04
Status : Valid
Issue Date : 2024-07-17
Type : Chemical
Substance Number : 2280
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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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Japanese Pharmacopoeia Fexofenadine Hydrochloride
Registration Number : 229MF10083
Registrant's Address : B-4,IDA,Gandhinagar,Hyderabad-500037,Telangana,INDIA
Initial Date of Registration : 2017-04-11
Latest Date of Registration : 2017-04-11
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Registration Number : 226MF10224
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Registration Number : 302MF10017
Registrant's Address : Brueningstrasse 50, 65926 Frankfurt am Main, Germany
Initial Date of Registration : 2020-01-31
Latest Date of Registration : 2020-01-31
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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 : 2020-10-05
Registration Number : 222MF10270
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2010-12-10
Latest Date of Registration : 2022-09-29
Registration Number : 228MF10070
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2016-03-02
Latest Date of Registration : 2021-11-17
Registration Number : 226MF10024
Registrant's Address : Village-Bhagwanpur, Barwala Road, Derabassi-140 507 District-S. A. S. Nagar (Mohali)P...
Initial Date of Registration : 2014-01-21
Latest Date of Registration : 2018-08-08
Fexofenadine hydrochloride (C)
Registration Number : 302MF10093
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2020-08-05
Latest Date of Registration : 2020-08-05
Japanese Pharmacopoeia Fexofenadine Hydrochloride For manufacturing only
Registration Number : 230MF10064
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2018-05-08
Latest Date of Registration : 2018-05-08
Japanese Pharmacopoeia Fexofenadine Hydrochloride
Registration Number : 223MF10088
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-06-27
Latest Date of Registration : 2021-08-16
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Fexofenadine Hydrochloride IP/BP/USP/EP
Date of Issue : 2024-01-15
Valid Till : 2027-01-15
Written Confirmation Number : WC-0575
Address of the Firm : Plot No. 30 to 33 Phase-l, IDA Pashamylaram Patancheru IDA Pashamylaram, Sangare...
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Fexofenadine Hydrochloride BP/EP/USP
Date of Issue : 2022-09-16
Valid Till : 2025-07-02
Written Confirmation Number : WC-0191
Address of the Firm : Sy. No. 10, Gaddapotharam (V), Jinnaram (M), Sangareddy District-502319, Telanga...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Fexofenadine Hydrochloride USP/EP
Date of Issue : 2022-06-08
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043Amended
Address of the Firm : Chemical Technical Operations - Unit V, Peddadevulapally Village, Tripuraram Man...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Fexofenadine Hydrochloride USP
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm : Plot No-8, Jawaharlal Nehru Pharamacity,Tadi (v), Parawada (M), Vishakapatnam Di...
Fexofenadine Hydrochloride (IP/USP/BP/Ph.Eur.)
Date of Issue : 2013-08-30
Valid Till : 2016-07-02
Written Confirmation Number : WC-0240
Address of the Firm : Plot No.145-150,153,154A,IDA, Kondapally, Ibrahimpatnam Mandal,Krishna District-...
Fexofenadine Hydrochloride (Ph.Eur.)
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit No. VIII, Sy. No. 10 & 13, Gaddapotharam Village, I,D.A. Kazipally, Jinnara...
Fexofenadine Hydrochloride (USP/Ph. EurJBP!JP)
Date of Issue : 2022-06-03
Valid Till : 2025-05-27
Written Confirmation Number : WC-0003
Address of the Firm : Vill.- Bhagwanpur, Barwala Road, Near Dera Bassi, Distt.- SAS Nagar (Mohali), Pu...
Fexofenadine Hydrochloride (USP/EP) –
Date of Issue : 2019-06-17
Valid Till : 2022-06-16
Written Confirmation Number : WC-0050
Address of the Firm : Village- Malkumajra (Morepen Village), Baddi Nalagarh Road, Distt. - Solan (Hima...
Fexofenadine Hydrochloride BP/USP/EP/IP
Date of Issue : 2019-10-28
Valid Till : 2022-06-15
Written Confirmation Number : WC-0371
Address of the Firm : Plot No.59 E, Road No3 Jawaharalal Nehru Pharma City Parawada mandal, Visakhapat...
Fexofenadine Hydrochloride (USP/EP/IH)
Date of Issue : 2022-06-08
Valid Till : 2025-06-02
Written Confirmation Number : WC-0011nA2
Address of the Firm : Village toansa, P.O Rail Majra, District S.B.S nagar nawanshahar-144533 Punjab I...
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Registrant Name : Bansen Co., Ltd.
Registration Date : 2022-03-24
Registration Number : 20220324-209-J-1154
Manufacturer Name : M/S.Virupaksha Organics Ltd
Manufacturer Address : Sy.No. 10, Gaddapothram Village, Jinnaram Mandal, Sangareddy District, Telangana Stat...
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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, Fran...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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, Indi...
Registrant Name : Dongbang FTL Co., Ltd.
Registration Date : 2019-04-23
Registration Number : 20190423-209-J-337
Manufacturer Name : Dongbang FTL Co., Ltd.
Manufacturer Address : 78, Yakjakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2020-12-07
Registration Number : 20201207-209-J-638
Manufacturer Name : Synthimed Labs Private Limit...
Manufacturer Address : Village Bhagwanpur, Barwala Road, Derabassi-140507, District SAS Nagar (Mohali), Punj...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-05-01
Registration Number : 20240501-209-J-1622
Manufacturer Name : Morepen Laboratories Limited
Manufacturer Address : (Morepen Village)Vill. Malkumajra, Baddi-Nalagarh Road, Baddi. District-Solan (Himach...
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Registration Number : 20201207-209-J-638(1)
Manufacturer Name : Synthimed Labs Private Limit...
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Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-10-20
Registration Number : 20181126-209-J-89(1)
Manufacturer Name : Vasudha Pharma Chem Limited
Manufacturer Address : Unit-II, Plot No. 79., JN Pharma City, Thanam(V) Parawada(M), Visakhapatnam District-...
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Registration Date : 2018-11-26
Registration Number : 20181126-209-J-89
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NDC Package Code : 51686-0001
Start Marketing Date : 2007-10-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
NDC Package Code : 62207-002
Start Marketing Date : 2018-06-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65862-966
Start Marketing Date : 2023-12-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 46438-0107
Start Marketing Date : 2006-12-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 46438-0638
Start Marketing Date : 2016-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65977-0060
Start Marketing Date : 2000-02-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62993-0809
Start Marketing Date : 2020-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-0016
Start Marketing Date : 2016-08-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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ABOUT THIS PAGE
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.
A Fexofenadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fexofenadine Hydrochloride, including repackagers and relabelers. The FDA regulates Fexofenadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fexofenadine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fexofenadine Hydrochloride supplier is an individual or a company that provides Fexofenadine Hydrochloride active pharmaceutical ingredient (API) or Fexofenadine Hydrochloride finished formulations upon request. The Fexofenadine Hydrochloride suppliers may include Fexofenadine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Fexofenadine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fexofenadine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Fexofenadine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Fexofenadine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Fexofenadine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fexofenadine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Fexofenadine Hydrochloride USDMF includes data on Fexofenadine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fexofenadine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fexofenadine Hydrochloride 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 Hydrochloride Drug Master File in Japan (Fexofenadine Hydrochloride JDMF) empowers Fexofenadine Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Fexofenadine Hydrochloride 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 Hydrochloride 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 Hydrochloride Drug Master File in Korea (Fexofenadine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fexofenadine Hydrochloride. The MFDS reviews the Fexofenadine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Fexofenadine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fexofenadine Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fexofenadine Hydrochloride suppliers with KDMF on PharmaCompass.
A Fexofenadine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Fexofenadine Hydrochloride Certificate of Suitability (COS). The purpose of a Fexofenadine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fexofenadine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fexofenadine Hydrochloride to their clients by showing that a Fexofenadine Hydrochloride CEP has been issued for it. The manufacturer submits a Fexofenadine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fexofenadine Hydrochloride CEP holder for the record. Additionally, the data presented in the Fexofenadine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fexofenadine Hydrochloride DMF.
A Fexofenadine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fexofenadine Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Fexofenadine Hydrochloride written confirmation (Fexofenadine Hydrochloride WC) is an official document issued by a regulatory agency to a Fexofenadine Hydrochloride manufacturer, verifying that the manufacturing facility of a Fexofenadine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fexofenadine Hydrochloride APIs or Fexofenadine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Fexofenadine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Fexofenadine Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fexofenadine Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fexofenadine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fexofenadine Hydrochloride suppliers with NDC on PharmaCompass.
Fexofenadine Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Fexofenadine Hydrochloride GMP API supplier for your needs.
A Fexofenadine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Fexofenadine Hydrochloride's compliance with Fexofenadine Hydrochloride specifications and serves as a tool for batch-level quality control.
Fexofenadine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Fexofenadine Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Fexofenadine Hydrochloride EP), Fexofenadine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fexofenadine Hydrochloride USP).
