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1. (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic Acid
2. Alerlisin
3. Aller-tec
4. Cetalerg
5. Ceterifug
6. Ceti Tad
7. Ceti-puren
8. Cetiderm
9. Cetidura
10. Cetil Von Ct
11. Cetilich
12. Cetirigamma
13. Cetirizin Al
14. Cetirizin Azu
15. Cetirizin Basics
16. Cetirizine
17. Cetirizine Dihydrochloride
18. Cetirlan
19. Dihydrochloride, Cetirizine
20. P 071
21. P-071
22. P071
23. Reactine
24. Virlix
25. Voltric
26. Zetir
27. Zirtek
28. Zyrtec
1. Cetirizine Dihydrochloride
2. 83881-52-1
3. Zyrtec
4. Reactine
5. Cetirizine Dihcl
6. Cetrine
7. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride
8. Alerlisin
9. Cetirizine Hcl
10. Virlix
11. P 071
12. Zirtek
13. P-071
14. Zerviate
15. Cetirizine (dihydrochloride)
16. 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid;dihydrochloride
17. 83881-52-1 (hcl)
18. 64o047ktoa
19. Nsc-759102
20. Cetirigamma
21. Alercet
22. Alergex
23. Alertisin
24. Cetalerg
25. Ceterifug
26. Cetidura
27. Cetirlan
28. Cetriler
29. Cetzine
30. Formistin
31. Ressital
32. Salvalerg
33. Setiral
34. Stopaler
35. Voltric
36. Zyrzine
37. Alerid
38. Riztec
39. Virdos
40. Zirtin
41. Cezin
42. Ryzen
43. Zetir
44. Cetilich
45. Triz
46. Cetirizin Basics
47. Xero-sed
48. Ceti-puren
49. Cetil Von Ct
50. Cetirizin Azu
51. Children's Zyrtec
52. (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic Acid Dihydrochloride
53. [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Dihydrochloride
54. Dsstox_cid_24268
55. Dsstox_rid_80138
56. Dsstox_gsid_44268
57. Ceti Tad
58. Alleroff
59. Allergy Relief
60. Apo-cetirizine
61. Zyrtec Allergy
62. Zyrtec Hives Relief
63. Cetirizine Hydrochloride [usan]
64. Ucb-p 071
65. Topcare All Day Allergy
66. Sun Mark All Day Allergy
67. Children's Zyrtec Allergy
68. Unii-64o047ktoa
69. Cetirizine Hydrochloride Hives
70. Cetirizine Di
71. Children's Zyrtec Hives Relief
72. Sr-01000688282
73. Cetirizine Hydrochloride Allergy
74. Cetirizine 2hcl
75. Up And Up All Day Allergy Relief
76. Prestwick_841
77. Cetirizine Hydrochloride [usan:usp]
78. Xyzal Dihydrochloride
79. Zyrtec (tn)
80. Quzyttir
81. 774596-22-4
82. Ox-nla
83. Children's Cetirizine Hydrochloride Allergy
84. Ncgc00016949-01
85. Cetirizine-d8 Hydrochloride
86. Cas-83881-52-1
87. Children's Cetirizine Hydrochloride Hives Relief
88. (+-)-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid, Dihydrochloride
89. Schembl41107
90. Spectrum1505371
91. Chebi:3562
92. Ucb P071
93. Cetirizine Hydrochloride (1:2)
94. Chembl1607273
95. Dtxsid2044268
96. Hms1569f07
97. Hms1922h04
98. Bcp09018
99. Tox21_110704
100. Tox21_302261
101. Tox21_500362
102. Hy-17042a
103. Mfcd00941428
104. S1291
105. Cetirizine Hydrochloride (jp17/usp)
106. Cetirizine Hydrochloride [jan]
107. Akos000280979
108. Akos016340521
109. Tox21_110704_1
110. Ac-1600
111. Ccg-213404
112. Cetirizine Dihydrochloride [mi]
113. Cs-1798
114. Ks-1042
115. Lp00362
116. Nsc 759102
117. Cetirizine Hydrochloride [mart.]
118. Cetirizine Hydrochloride [vandf]
119. Cetirizine Hydrochloride [usp-rs]
120. Cetirizine Hydrochloride [who-dd]
121. Ncgc00095180-01
122. Ncgc00095180-02
123. Ncgc00255965-01
124. Ncgc00261047-01
125. Ncgc00263567-01
126. Acetic Acid, (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride, (+-)-
127. Bc164297
128. Cetirizine Dihydrochloride, >=98% (hplc)
129. Db-056756
130. (r)-cetirizine Dihcl (levocetirizine Dihcl)
131. Ft-0603000
132. Ft-0631130
133. Ft-0664487
134. Sw196972-3
135. Cetirizin Dihydrochloride, >=98.0% (hplc)
136. Cetirizine Hydrochloride [orange Book]
137. Cetirizine Hydrochloride [usp Monograph]
138. D00664
139. F20462
140. Cetirizine Dihydrochloride [ep Monograph]
141. 881c510
142. A840675
143. Zyrtec-d Component Cetirizine Hydrochloride
144. Sr-01000688282-3
145. Cetirizine Hydrochloride Component Of Zyrtec-d
146. Q27263769
147. Cetirizine Dihydrochloride 1.0 Mg/ml In Water (as Free Base)
148. Cetirizine Dihydrochloride, European Pharmacopoeia (ep) Reference Standard
149. Cetirizine Hydrochloride, British Pharmacopoeia (bp) Reference Standard
150. (rs)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy}-acetic Acid Dihydrochloride
151. [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]aceticaciddihydrochloride
152. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid 2hcl
153. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)aceticaciddihydrochloride
154. Cetirizine Dihydrochloride, United States Pharmacopeia (usp) Reference Standard
155. Cetirizine For Peak Identification, European Pharmacopoeia (ep) Reference Standard
156. Cetirizine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
157. (+) {2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazine-1-yl] -ethoxy}-acetic Acid Dihydrochloride
158. (+/-)-(2-(4-(p-chloro-a-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid, Dihydrochloride
159. (+/-){2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]-ethoxy}-acetic Acid Dihydrochloride
160. (rs)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy }-acetic Acid Dihydrochloride
161. 2-(2-(4-(p-chloro-alpha-phenylbenzyl)1-piperazinyl)ethoxy) Acetic Acid Dihydrochloride
162. 2-(2-{4-[(4-chlorophenyl)(phenyl)-methyl]piperazino}ethoxy)acetic Acid Dihydrochloride;cetirizine Dihydrochloride
163. Acetic Acid, (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride, (+/-)-
164. Acetic Acid, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, Hydrochloride (1:2)
165. Cetirizine Dihydrochloride Solution, 1.0 Mg/ml In Acetonitrile: Water (9:1) (as Free Base), Ampule Of 1 Ml, Certified Reference Material
1. Cetirizin Dihydrochloride
2. Cetirizine Hcl
| Molecular Weight | 461.8 g/mol |
|---|---|
| Molecular Formula | C21H27Cl3N2O3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 8 |
| Exact Mass | 460.108726 g/mol |
| Monoisotopic Mass | 460.108726 g/mol |
| Topological Polar Surface Area | 53 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 443 |
| 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 | 3 |
| 1 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride |
| Drug Label | Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is () - [2- [4- [ (4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic comp... |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Perrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro |
| 2 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Capsule; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Wockhardt; Ranbaxy; Amneal Pharms Ny; Ipca Labs; Unichem; Apotex; Contract Pharmacal; Sun Pharm Inds; Taro; Torrent Pharms; Cadista Pharms; Dr Reddys Labs; Sandoz; Unique Pharm Labs; Banner Pharmacaps; Cipla; Orchid Hlthcare; Mylan |
| 3 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride hives |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Ranbaxy; Ipca Labs; Unichem; Sun Pharm Inds; Cadista Pharms; Dr Reddys Labs; Unique Pharm Labs; Orchid Hlthcare; Mylan |
| 4 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 5 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 6 of 20 | |
|---|---|
| Drug Name | Children's zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 7 of 20 | |
|---|---|
| Drug Name | Children's zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 8 of 20 | |
|---|---|
| Drug Name | Zyrtec |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Mcneil Consumer |
| 9 of 20 | |
|---|---|
| Drug Name | Zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Tablet, orally disintegrating |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 10 of 20 | |
|---|---|
| Drug Name | Zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 11 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride |
| Drug Label | Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is () - [2- [4- [ (4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic comp... |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Perrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro |
| 12 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Capsule; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Wockhardt; Ranbaxy; Amneal Pharms Ny; Ipca Labs; Unichem; Apotex; Contract Pharmacal; Sun Pharm Inds; Taro; Torrent Pharms; Cadista Pharms; Dr Reddys Labs; Sandoz; Unique Pharm Labs; Banner Pharmacaps; Cipla; Orchid Hlthcare; Mylan |
| 13 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride hives |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Ranbaxy; Ipca Labs; Unichem; Sun Pharm Inds; Cadista Pharms; Dr Reddys Labs; Unique Pharm Labs; Orchid Hlthcare; Mylan |
| 14 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 15 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 16 of 20 | |
|---|---|
| Drug Name | Children's zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 17 of 20 | |
|---|---|
| Drug Name | Children's zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 18 of 20 | |
|---|---|
| Drug Name | Zyrtec |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Mcneil Consumer |
| 19 of 20 | |
|---|---|
| Drug Name | Zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Tablet, orally disintegrating |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 20 of 20 | |
|---|---|
| Drug Name | Zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
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.)
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.)
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Cetirizine Dihydrochloride, Process B
Certificate Number : CEP 2021-309 - Rev 02
Status : Valid
Issue Date : 2024-10-23
Type : Chemical
Substance Number : 1084
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Certificate Number : CEP 2004-047 - Rev 08
Status : Valid
Issue Date : 2024-09-30
Type : Chemical
Substance Number : 1084
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.
Cetirizine Dihydrochloride, Process II
Certificate Number : R1-CEP 2009-206 - Rev 03
Status : Valid
Issue Date : 2020-01-08
Type : Chemical
Substance Number : 1084
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.
Certificate Number : R1-CEP 2003-049 - Rev 07
Status : Valid
Issue Date : 2018-10-01
Type : Chemical
Substance Number : 1084
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : CEP 2009-349 - Rev 02
Status : Valid
Issue Date : 2024-10-16
Type : Chemical
Substance Number : 1084
Certificate Number : R1-CEP 2012-200 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2018-11-05
Type : Chemical
Substance Number : 1084
Certificate Number : R1-CEP 2000-081 - Rev 07
Status : Valid
Issue Date : 2019-08-09
Type : Chemical
Substance Number : 1084
Cetirizine Dihydrochloride, Unit II, Visakhapatn...
Certificate Number : R1-CEP 2011-292 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-02-09
Type : Chemical
Substance Number : 1084
Certificate Number : R1-CEP 2006-309 - Rev 01
Status : Valid
Issue Date : 2017-08-03
Type : Chemical
Substance Number : 1084
Certificate Number : R1-CEP 2001-144 - Rev 06
Status : Valid
Issue Date : 2018-08-08
Type : Chemical
Substance Number : 1084
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A Cetirizine Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetirizine Dihydrochloride, including repackagers and relabelers. The FDA regulates Cetirizine Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetirizine Dihydrochloride supplier is an individual or a company that provides Cetirizine Dihydrochloride active pharmaceutical ingredient (API) or Cetirizine Dihydrochloride finished formulations upon request. The Cetirizine Dihydrochloride suppliers may include Cetirizine Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cetirizine Dihydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetirizine Dihydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetirizine Dihydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cetirizine Dihydrochloride DMFs exist exist since differing nations have different regulations, such as Cetirizine Dihydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetirizine Dihydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cetirizine Dihydrochloride USDMF includes data on Cetirizine Dihydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetirizine Dihydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride Drug Master File in Japan (Cetirizine Dihydrochloride JDMF) empowers Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride Drug Master File in Korea (Cetirizine Dihydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cetirizine Dihydrochloride. The MFDS reviews the Cetirizine Dihydrochloride KDMF as part of the drug registration process and uses the information provided in the Cetirizine Dihydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cetirizine Dihydrochloride suppliers with KDMF on PharmaCompass.
A Cetirizine Dihydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Cetirizine Dihydrochloride Certificate of Suitability (COS). The purpose of a Cetirizine Dihydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cetirizine Dihydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cetirizine Dihydrochloride to their clients by showing that a Cetirizine Dihydrochloride CEP has been issued for it. The manufacturer submits a Cetirizine Dihydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cetirizine Dihydrochloride CEP holder for the record. Additionally, the data presented in the Cetirizine Dihydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cetirizine Dihydrochloride DMF.
A Cetirizine Dihydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride suppliers with CEP (COS) on PharmaCompass.
A Cetirizine Dihydrochloride written confirmation (Cetirizine Dihydrochloride WC) is an official document issued by a regulatory agency to a Cetirizine Dihydrochloride manufacturer, verifying that the manufacturing facility of a Cetirizine Dihydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cetirizine Dihydrochloride APIs or Cetirizine Dihydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Cetirizine Dihydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cetirizine Dihydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cetirizine Dihydrochloride suppliers with NDC on PharmaCompass.
Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride GMP manufacturer or Cetirizine Dihydrochloride GMP API supplier for your needs.
A Cetirizine Dihydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cetirizine Dihydrochloride's compliance with Cetirizine Dihydrochloride specifications and serves as a tool for batch-level quality control.
Cetirizine Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cetirizine Dihydrochloride 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.
Cetirizine Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetirizine Dihydrochloride EP), Cetirizine Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetirizine Dihydrochloride USP).
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