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    Chemistry

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    Also known as: Cetirizine dihydrochloride, 83881-52-1, Zyrtec, Reactine, Cetirizine dihcl, Cetrine
    Molecular Formula
    C21H27Cl3N2O3
    Molecular Weight
    461.8  g/mol
    InChI Key
    PGLIUCLTXOYQMV-UHFFFAOYSA-N
    FDA UNII
    64O047KTOA
    Cetirizine Dihydrochloride
    A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.
    1 2D Structure

    Cetirizine Dihydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid;dihydrochloride
    2.1.2 InChI
    InChI=1S/C21H25ClN2O3.2ClH/c22-19-8-6-18(7-9-19)21(17-4-2-1-3-5-17)24-12-10-23(11-13-24)14-15-27-16-20(25)26;;/h1-9,21H,10-16H2,(H,25,26);2*1H
    2.1.3 InChI Key
    PGLIUCLTXOYQMV-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CN(CCN1CCOCC(=O)O)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl.Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    64O047KTOA
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    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

    2.3.2 Depositor-Supplied Synonyms

    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

    2.3.3 Other Synonyms

    1. Cetirizin Dihydrochloride

    2. Cetirizine Hcl

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 461.8 g/mol
    Molecular Formula C21H27Cl3N2O3
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count8
    Exact Mass460.108726 g/mol
    Monoisotopic Mass460.108726 g/mol
    Topological Polar Surface Area53 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity443
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 20  
    Drug NameCetirizine hydrochloride
    Drug LabelCetirizine 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 IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusPrescription
    CompanyPerrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro

    2 of 20  
    Drug NameCetirizine hydrochloride allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet; Capsule; Tablet, chewable
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyPerrigo 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 NameCetirizine hydrochloride hives
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyPerrigo 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 NameChildren's cetirizine hydrochloride allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup; Tablet, chewable
    RouteOral
    Strength5mg; 10mg; 5mg/5ml
    Market StatusOver the Counter
    CompanyPerrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma

    5 of 20  
    Drug NameChildren's cetirizine hydrochloride hives relief
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup; Tablet, chewable
    RouteOral
    Strength5mg; 10mg; 5mg/5ml
    Market StatusOver the Counter
    CompanyPerrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma

    6 of 20  
    Drug NameChildren's zyrtec allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusOver the Counter
    CompanyMcneil Consumer

    7 of 20  
    Drug NameChildren's zyrtec hives relief
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusOver the Counter
    CompanyMcneil Consumer

    8 of 20  
    Drug NameZyrtec
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusPrescription
    CompanyMcneil Consumer

    9 of 20  
    Drug NameZyrtec allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet; Tablet, orally disintegrating
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyMcneil Consumer

    10 of 20  
    Drug NameZyrtec hives relief
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyMcneil Consumer

    11 of 20  
    Drug NameCetirizine hydrochloride
    Drug LabelCetirizine 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 IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusPrescription
    CompanyPerrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro

    12 of 20  
    Drug NameCetirizine hydrochloride allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet; Capsule; Tablet, chewable
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyPerrigo 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 NameCetirizine hydrochloride hives
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyPerrigo 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 NameChildren's cetirizine hydrochloride allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup; Tablet, chewable
    RouteOral
    Strength5mg; 10mg; 5mg/5ml
    Market StatusOver the Counter
    CompanyPerrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma

    15 of 20  
    Drug NameChildren's cetirizine hydrochloride hives relief
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup; Tablet, chewable
    RouteOral
    Strength5mg; 10mg; 5mg/5ml
    Market StatusOver the Counter
    CompanyPerrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma

    16 of 20  
    Drug NameChildren's zyrtec allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusOver the Counter
    CompanyMcneil Consumer

    17 of 20  
    Drug NameChildren's zyrtec hives relief
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusOver the Counter
    CompanyMcneil Consumer

    18 of 20  
    Drug NameZyrtec
    Active IngredientCetirizine hydrochloride
    Dosage FormSyrup
    RouteOral
    Strength5mg/5ml
    Market StatusPrescription
    CompanyMcneil Consumer

    19 of 20  
    Drug NameZyrtec allergy
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet; Tablet, orally disintegrating
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyMcneil Consumer

    20 of 20  
    Drug NameZyrtec hives relief
    Active IngredientCetirizine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg
    Market StatusOver the Counter
    CompanyMcneil Consumer

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]

    USDMF

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    Dr Reddys Laboratories Ltd

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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-03-23

    Pay. Date : 2015-12-14

    DMF Number : 30063

    Submission : 2016-02-01

    Status : Active

    Type : II

    Granules India

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    06

    Cosma Spa

    Italy
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    Not Confirmed
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    Virtual BoothCosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2024-07-10

    Pay. Date : 2024-07-05

    DMF Number : 20309

    Submission : 2007-02-21

    Status : Active

    Type : II

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    07

    IPPE
    Not Confirmed

    07

    Cambrex Charles City Inc

    U.S.A
    arrow
    IPPE
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15219

    Submission : 2000-12-22

    Status : Inactive

    Type : II

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    08

    Cipla Ltd

    India

    USDMF

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    IPPE
    Not Confirmed

    08

    Cipla Ltd

    India
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    IPPE
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-03-25

    Pay. Date : 2016-03-08

    DMF Number : 15145

    Submission : 2000-11-17

    Status : Active

    Type : II

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    09

    Kv Pharmaceutical Co

    Switzerland

    USDMF

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    IPPE
    Not Confirmed

    09

    Kv Pharmaceutical Co

    Switzerland
    arrow
    IPPE
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9809

    Submission : 1992-08-03

    Status : Inactive

    Type : II

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    10

    IPPE
    Not Confirmed

    10

    Taro Pharmaceutical Industries Ltd

    U.S.A
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    IPPE
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16262

    Submission : 2002-11-27

    Status : Active

    Type : II

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    CEP/COS

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    WAVELENGTH ENTERPRISES LTD. Petah T...

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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    Cetirizine dihydrochloride

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    CEP 2004-047 - Rev 08
    Valid
    Chemical
    2024-09-30
    1084
    Seqens Company Banner

    01

    WAVELENGTH ENTERPRISES LTD. Petah T...

    France
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    IPPE
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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    Cetirizine Dihydrochloride

    Certificate Number : CEP 2004-047 - Rev 08

    Status : Valid

    Issue Date : 2024-09-30

    Type : Chemical

    Substance Number : 1084

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    DR. REDDY'S LABORATORIES LIMITED Hy...

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Cetirizine dihydrochloride, Process II

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    R1-CEP 2009-206 - Rev 03
    Valid
    Chemical
    2020-01-08
    1084
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    02

    DR. REDDY'S LABORATORIES LIMITED Hy...

    India
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    Cetirizine Dihydrochloride, Process II

    Certificate Number : R1-CEP 2009-206 - Rev 03

    Status : Valid

    Issue Date : 2020-01-08

    Type : Chemical

    Substance Number : 1084

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    DR. REDDY'S LABORATORIES LIMITED Hy...

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Cetirizine dihydrochloride

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    R1-CEP 2003-049 - Rev 07
    Valid
    Chemical
    2018-10-01
    1084
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    03

    DR. REDDY'S LABORATORIES LIMITED Hy...

    India
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    Cetirizine Dihydrochloride

    Certificate Number : R1-CEP 2003-049 - Rev 07

    Status : Valid

    Issue Date : 2018-10-01

    Type : Chemical

    Substance Number : 1084

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    AREVIPHARMA GMBH Radebeul DE

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    Cetirizine dihydrochloride

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    R1-CEP 2006-220 - Rev 04
    Valid
    Chemical
    2022-09-09
    1084
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    04

    AREVIPHARMA GMBH Radebeul DE

    Germany
    IPPE
    Not Confirmed
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    DISHMAN CARBOGEN AMCIS LIMITED Ahme...

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    Cetirizine dihydrochloride

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    R1-CEP 2012-200 - Rev 00
    Withdrawn by Holder
    Chemical
    2018-11-05
    2022-10-25
    1084
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    05

    DISHMAN CARBOGEN AMCIS LIMITED Ahme...

    Switzerland
    IPPE
    Not Confirmed
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    DISHMAN CARBOGEN AMCIS LIMITED Ahme...

    Switzerland
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    Cetirizine Dihydrochloride

    Certificate Number : R1-CEP 2012-200 - Rev 00

    Status : Withdrawn by Holder

    Issue Date : 2018-11-05

    Type : Chemical

    Substance Number : 1084

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    GLOCHEM INDUSTRIES PRIVATE LIMITED ...

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    Cetirizine dihydrochloride

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    R1-CEP 2003-171 - Rev 06
    Valid
    Chemical
    2022-01-21
    1084
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    06

    GLOCHEM INDUSTRIES PRIVATE LIMITED ...

    India
    IPPE
    Not Confirmed
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    GLOCHEM INDUSTRIES LIMITED Hyderaba...

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    Cetirizine dihydrochloride, Unit II, Visakhapatnam

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    R1-CEP 2011-292 - Rev 00
    Withdrawn by Holder
    Chemical
    2017-02-09
    2020-01-28
    1084
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    07

    GLOCHEM INDUSTRIES LIMITED Hyderaba...

    India
    IPPE
    Not Confirmed
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    INDOCO REMEDIES LIMITED Mumbai IN

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    Cetirizine dihydrochloride

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    R0-CEP 2021-475 - Rev 00
    Valid
    Chemical
    2023-01-11
    1084
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    08

    INDOCO REMEDIES LIMITED Mumbai IN

    India
    IPPE
    Not Confirmed
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    JUBILANT PHARMOVA LIMITED Nanjangud...

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    Cetirizine dihydrochloride

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    R1-CEP 2007-114 - Rev 05
    Valid
    Chemical
    2022-08-23
    1084
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    09

    JUBILANT PHARMOVA LIMITED Nanjangud...

    India
    IPPE
    Not Confirmed
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    SOLARA ACTIVE PHARMA SCIENCES LIMIT...

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    Cetirizine dihydrochloride

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    R1-CEP 2001-144 - Rev 06
    Valid
    Chemical
    2018-08-08
    1084
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    10

    SOLARA ACTIVE PHARMA SCIENCES LIMIT...

    India
    IPPE
    Not Confirmed
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    JDMF

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    01

    Wavelength Enterprises Ltd

    France
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    IPPE
    Not Confirmed
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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    Cetirizine hydrochloride

    Registration Number : 218MF10400

    Registrant's Address : Ofer Park, Building E, 5th floor, 94 Shlomo Shmeltzer Road, POB 3158, Petah Tikva 497...

    Initial Date of Registration : 2006-04-14

    Latest Date of Registration : 2018-10-01

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    02

    Dr. Reddy's Laboratories Ltd.

    India
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    CETIRIZINE DIHYDROCHLORIDE EP

    Registration Number : 218MF10306

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2006-04-20

    Latest Date of Registration : 2006-12-18

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    03

    Daito Co., Ltd.

    Japan
    IPPE
    Not Confirmed
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    Daito Co., Ltd.

    Japan
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    IPPE
    Not Confirmed
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    Japanese Pharmacopoeia Cetirizine Hydrochloride (for manufacturing purposes only)

    Registration Number : 220MF10084

    Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture

    Initial Date of Registration : 2008-03-18

    Latest Date of Registration : 2008-03-18

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    04

    SperaNexus Co., Ltd.

    Japan
    IPPE
    Not Confirmed
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    SperaNexus Co., Ltd.

    Japan
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    IPPE
    Not Confirmed
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    Cetirizine Hydrochloride

    Registration Number : 218MF10273

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2006-02-23

    Latest Date of Registration : 2007-01-22

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    05

    Permakem Asia Co., Ltd.

    Japan
    IPPE
    Not Confirmed
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    Permakem Asia Co., Ltd.

    Japan
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    IPPE
    Not Confirmed
    • fda
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    Cetirizine hydrochloride

    Registration Number : 218MF10005

    Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo

    Initial Date of Registration : 2006-01-12

    Latest Date of Registration : 2006-12-27

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    EU WC

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    01

    Supriya Lifescience

    India
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    IPPE
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    Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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    Cetirizine Dihydrochloride USP

    Date of Issue : 2025-09-02

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0218

    Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...

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    02

    Supriya Lifescience

    India
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    IPPE
    Not Confirmed
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    Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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    Cetirizine Hydrochloride USP

    Date of Issue : 2025-09-02

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0218

    Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...

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    03

    Dr. Reddy's Laboratories

    India
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    Cetirizine Dihydrochloride Ph. Eur

    Date of Issue : 2025-06-20

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm : UNIT-I, Plot Nos. 137, 138, 145 & 146, Sri Venkateswara Co-operative Industrial ...

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    04

    Cipla

    India
    IPPE
    Not Confirmed
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    Cipla

    India
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    Not Confirmed
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    Cetirizine Dihydrochloride EP

    Date of Issue : 2025-10-08

    Valid Till : 2028-09-08

    Written Confirmation Number : WC-0143

    Address of the Firm : Plot No. A-42 MIDC Patalganga Khalapur, Raigad-410220, Maharashtra India

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    05

    Cipla

    India
    IPPE
    Not Confirmed
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    Cipla

    India
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    IPPE
    Not Confirmed
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    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Cetirizine Dihydrochloride USP

    Date of Issue : 2025-08-29

    Valid Till : 2028-08-28

    Written Confirmation Number : WC-0142

    Address of the Firm : A-33, A-37/2/2 & A-2, M.I.D.C., Patalganga -410220, Taluka: Khalapur, District: ...

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    06

    Glochem Industries

    India
    IPPE
    Not Confirmed
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    Glochem Industries

    India
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    IPPE
    Not Confirmed
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    Cetirizine Hydrochloride USP/EP

    Date of Issue : 2025-12-24

    Valid Till : 2028-11-09

    Written Confirmation Number : WC-0013

    Address of the Firm : 174 to 176, IDA, Bollaram, Jinnaram Mandai, Sangareddy District, Telangana State...

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    07

    Ipca Laboratories

    India
    IPPE
    Not Confirmed
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    Ipca Laboratories

    India
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    IPPE
    Not Confirmed
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    Cetirizine Dihydrochloride BP/Ph.Eur./USP

    Date of Issue : 2025-06-19

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm : P.O. Sejavta, District -Ratlam, (M.P.)-457001, India

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    08

    Jubilant Biosys Ltd

    India
    IPPE
    Not Confirmed
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    Jubilant Biosys Ltd

    India
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    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Cetirizine Dihydrochloride USP

    Date of Issue : 2025-02-14

    Valid Till : 2027-11-04

    Written Confirmation Number : WC-0092

    Address of the Firm : Plot No. 18, 56, 57, 58, KIADB Industrial Area, Nanjangud, 571 302, Dist: Mysore...

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    09

    Maps Laboratories Private Limited

    India
    IPPE
    Not Confirmed
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    Maps Laboratories Private Limited

    India
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    Cetirizine Dihydrochloride Ph. Eur

    Date of Issue : 2025-07-07

    Valid Till : 2028-01-13

    Written Confirmation Number : WC-0331

    Address of the Firm : Plot No. 38, Rafaleshwar, G.I.D.C., N. H. No 8/A, At & Post. Jambudia

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    Viatris

    U.S.A
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    Viatris

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    Cetirizine Hydrochloride USP

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm : Unit-8, G.Chodavaram village, Pusapatirega Mandal, Vizianagaram District-535204,...

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    Supriya Lifescience

    India
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    Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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    Cetirizine hydrochloride

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-40-C-139-01

    Manufacturer Name : Supriya Lifescience Ltd.

    Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist-Ratnagiri 415722, Maharash...

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    Supriya Lifescience

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    Cetirizine hydrochloride

    Registrant Name : Sanil Pharmaceutical Co., Ltd.

    Registration Date : 2019-06-11

    Registration Number : 20050831-40-C-139-01(6)

    Manufacturer Name : Supriya Lifescience Ltd

    Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed. Dist-Ratnagiri, Maharashtra, Pi...

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    Supriya Lifescience

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    Cetirizine hydrochloride

    Registrant Name : GL Pharma Co., Ltd.

    Registration Date : 2017-02-15

    Registration Number : 20050831-40-C-139-01(4)

    Manufacturer Name : Supriya Lifescience Ltd

    Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Taluka-Khed, District-Ratnagiri, Maharash...

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    Supriya Lifescience

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    Cetirizine hydrochloride

    Registrant Name : Sanil Pharma Co., Ltd.

    Registration Date : 2017-12-08

    Registration Number : 20050831-40-C-139-01(5)

    Manufacturer Name : Supriya Lifescience Ltd

    Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Taluka-Khed, District-Ratnagiri, Maharash...

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    Supriya Lifescience

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    Cetirizine hydrochloride

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2014-06-05

    Registration Number : 20050831-40-C-139-01(3)

    Manufacturer Name : Supriya Lifescience Ltd

    Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Taluka-Khed, District-Ratnagiri, Maharash...

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    Supriya Lifescience

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    Cetirizine hydrochloride

    Registrant Name : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2021-11-08

    Registration Number : 20050831-40-C-139-01(7)

    Manufacturer Name : Supriya Lifescience Ltd.

    Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist-Ratnagiri 415722, Maharash...

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    Supriya Lifescience

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    Cetirizine hydrochloride

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2014-03-14

    Registration Number : 20050831-40-C-139-01(2)

    Manufacturer Name : Supriya Lifescience Ltd

    Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Taluka-Khed, District-Ratnagiri, Maharash...

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    Dr. Reddy's Laboratories

    India
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    Cetirizine hydrochloride

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2011-05-31

    Registration Number : 20050831-40-C-145-06(1)

    Manufacturer Name : Dr. Reddy's Laboratories, Lt...

    Manufacturer Address : Plot No. 137 & 138, 145 & 146, Sri Venkateswara Cooperative industrial estate, Bollar...

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    Dr. Reddy's Laboratories

    India
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    Cetirizine hydrochloride

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-40-C-145-06

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : Plot No. 137 & 138, 145 & 146, Sri Venkateswara Co-operative industrial estate,Bollar...

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    Dr. Reddy's Laboratories

    India
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    Cetirizine hydrochloride

    Registrant Name : Pamirae Co., Ltd.

    Registration Date : 2022-09-16

    Registration Number : 20050831-40-C-145-06(4)

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : Plot No. 137 & 138, 145 & 146, Sri Venkateswara Co-operative industrial estate,Bollar...

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    API Reference Price

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REDDY COLONY, BANJARA HILLS,, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1644517800,"product":"CETIRIZINE DIHYDROCHLORIDE PH.EUR.","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE, ROAD NO.3, BANJARA HILLS, Contact N","city":"HYDERABAD","supplier":"DR REDDY'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"MANILA","customer":"INTERPHIL LABORATORIES INC","customerCountry":"PHILIPPINES","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"330","totalValueFC":"3121.8","currency":"USD","unitRateINR":23400,"date":"11-Feb-2022","totalValueINR":"234000","totalValueInUsd":"3121.8","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"8158219","productDescription":"API","marketType":"","country":"PHILIPPINES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE, ROAD NO.3, BANJARA HILLS, Contact N, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645122600,"product":"CETIRIZINE DI HCL EP (25 KGS X 1 DRUM(","address":"3A, AVSAR BLDG., 3RD FLR., 77\/81,K AZI SAYED ST., MASJID WEST,","city":"MUMBAI,MAHARASHTRA","supplier":"GRADIENT EXPORTS","supplierCountry":"INDIA","foreign_port":"MANILA NORTH HARBOR","customer":"UNDISCLOSED","customerCountry":"PHILIPPINES","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"54","totalValueFC":"1334.1","currency":"USD","unitRateINR":4000,"date":"18-Feb-2022","totalValueINR":"100000","totalValueInUsd":"1334.1","indian_port":"JNPT","hs_no":"29420090","bill_no":"8318620","productDescription":"API","marketType":"","country":"PHILIPPINES","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"3A, AVSAR BLDG., 3RD FLR., 77\/81,K AZI SAYED ST., MASJID WEST,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645209000,"product":"CETIRIZINE DIHYDROCHLORIDE EP","address":"504, ORCHID PLAZA, NR DATTAPADA,SU BWAY, BORIVALI WEST, MUMBAI,","city":"MUMBAI,MAHARASHTRA","supplier":"INDEX PHARMA LLP","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"P E D P","customerCountry":"INDONESIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"175","totalValueFC":"333.5","currency":"USD","unitRateINR":12500,"date":"19-Feb-2022","totalValueINR":"25000","totalValueInUsd":"333.5","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8350181","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"504, ORCHID PLAZA, NR DATTAPADA,SU BWAY, BORIVALI WEST, MUMBAI,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API 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    03-Jan-2022
    31-Dec-2025
    KGS
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    DOSAGE - SOLUTION;ORAL - 5MG/5ML

    USFDA APPLICATION NUMBER - 22155

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    DOSAGE - CAPSULE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 22429

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    DOSAGE - CAPSULE;ORAL - 5MG

    USFDA APPLICATION NUMBER - 22429

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    PharmaCompass offers a list of Cetirizine Dihydrochloride 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 Cetirizine Dihydrochloride manufacturer or Cetirizine Dihydrochloride supplier for your needs.

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

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

    API | Excipient name

    Cetirizine Dihydrochloride

    Synonyms

    83881-52-1, Zyrtec, Reactine, Cetirizine dihcl, Cetrine, 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid dihydrochloride

    Cas Number

    83881-52-1

    Unique Ingredient Identifier (UNII)

    64O047KTOA

    About Cetirizine Dihydrochloride

    A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard Manufacturers

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

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard Suppliers

    A Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard supplier is an individual or a company that provides Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard active pharmaceutical ingredient (API) or Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard finished formulations upon request. The Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard suppliers may include Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard API manufacturers, exporters, distributors and traders.

    click here to find a list of Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard USDMF

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

    A Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard DMF submitted to regulatory agencies in the US is known as a USDMF. Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard USDMF includes data on Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard USDMF is kept confidential to protect the manufacturer’s intellectual property.

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    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard Drug Master File in Japan (Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard JDMF) empowers Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard 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, United States Pharmacopeia (USP) Reference Standard JDMF during the approval evaluation for pharmaceutical products. At the time of Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard KDMF

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

    After submitting a Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard 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, United States Pharmacopeia (USP) Reference Standard API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard suppliers with KDMF on PharmaCompass.

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard CEP

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

    A Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard 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, United States Pharmacopeia (USP) Reference Standard suppliers with CEP (COS) on PharmaCompass.

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard WC

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

    click here to find a list of Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard suppliers with Written Confirmation (WC) on PharmaCompass.

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard NDC to their finished compounded human drug products, they may choose to do so.

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    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard GMP

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard 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, United States Pharmacopeia (USP) Reference Standard 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, United States Pharmacopeia (USP) Reference Standard GMP manufacturer or Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard GMP API supplier for your needs.

    Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard CoA

    A Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard CoA (Certificate of Analysis) is a formal document that attests to Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard's compliance with Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard specifications and serves as a tool for batch-level quality control.

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

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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