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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]

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    Dr. Reddy's Laboratories

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-16

    Pay. Date : 2014-06-06

    DMF Number : 18395

    Submission : 2005-05-27

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2003-049 - Rev 07

    Issue Date : 2018-10-01

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-06-20

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

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    Registrant Name : Pamire Co., Ltd.

    Registration Date : 2022-09-16

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

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : Plot No. 137 & 138, 145 & 146, Sri Venkateswara Co-operative industrial estate,Bollaram, Jinnaram Mandal, Sangareddy District, Telangana state, INDIA

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    06

    Jai Radhe Sales

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Pharm-RX Chemical

    U.S.A

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    Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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    Tenatra Exports

    India

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    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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    Zeon Pharma Industries India Pvt L...

    India

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    Virtual BoothZeon Pharma is a manufacturer and supplier of APIs & Intermediates.

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    Granules India Limited

    India

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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 : Reviewed

    Rev. Date : 2016-03-23

    Pay. Date : 2015-12-14

    DMF Number : 30063

    Submission : 2016-02-01

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62207-001

    Start Marketing Date : 2016-12-06

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    USDMF

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    Supriya Lifescience Ltd

    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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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39199

    Submission : 2024-02-06

    Status : Active

    Type : II

    Supriya

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    02

    Wavelength Enterprises Ltd

    France
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    BIO International Convention
    Attending
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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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    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-03-03

    Pay. Date : 2017-02-08

    DMF Number : 16244

    Submission : 2002-11-14

    Status : Active

    Type : II

    Seqens Company Banner

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    03

    Wavelength Enterprises Ltd

    France
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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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    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-04-05

    Pay. Date : 2021-01-05

    DMF Number : 35022

    Submission : 2021-01-24

    Status : Active

    Type : II

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    04

    Dr Reddys Laboratories Ltd

    India
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-06-16

    Pay. Date : 2014-06-06

    DMF Number : 18395

    Submission : 2005-05-27

    Status : Active

    Type : II

    Dr Reddy Company Banner

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    05

    Granules India Ltd

    India
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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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    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

    PEGS Boston Summit
    Not Confirmed

    07

    Cambrex Charles City Inc

    U.S.A
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    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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    Not Confirmed

    08

    Cipla Ltd

    India
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    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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    Not Confirmed

    09

    Kv Pharmaceutical Co

    Switzerland
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    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

    PEGS Boston Summit
    Not Confirmed

    10

    Taro Pharmaceutical Industries Ltd

    U.S.A
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    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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    WAVELENGTH ENTERPRISES LTD. Petah T...

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    • EDQM
    • fda
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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

    Portfolio PDF

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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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    Cetirizine Dihydrochloride

    Certificate Number : CEP 2004-047 - Rev 08

    Status : Valid

    Issue Date : 2024-09-30

    Type : Chemical

    Substance Number : 1084

    Seqens Company Banner

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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
    Dr Reddy Company Banner

    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

    Dr Reddy Company Banner

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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
    Dr Reddy Company Banner

    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

    Dr Reddy Company Banner

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    AREVIPHARMA GMBH Radebeul DE

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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
    PEGS Boston Summit
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    AREVIPHARMA GMBH Radebeul DE

    Germany
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    Cetirizine Dihydrochloride

    Certificate Number : R1-CEP 2006-220 - Rev 04

    Status : Valid

    Issue Date : 2022-09-09

    Type : Chemical

    Substance Number : 1084

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    GLOCHEM INDUSTRIES PRIVATE LIMITED ...

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    R1-CEP 2003-171 - Rev 06
    Valid
    Chemical
    2022-01-21
    1084
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    GLOCHEM INDUSTRIES PRIVATE LIMITED ...

    India
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    Not Confirmed
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    GLOCHEM INDUSTRIES PRIVATE LIMITED ...

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    Cetirizine Dihydrochloride

    Certificate Number : R1-CEP 2003-171 - Rev 06

    Status : Valid

    Issue Date : 2022-01-21

    Type : Chemical

    Substance Number : 1084

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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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    06

    GLOCHEM INDUSTRIES LIMITED Hyderaba...

    India
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    Not Confirmed
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    GLOCHEM INDUSTRIES LIMITED Hyderaba...

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    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

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    JUBILANT PHARMOVA LIMITED Nanjangud...

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    R1-CEP 2007-114 - Rev 05
    Valid
    Chemical
    2022-08-23
    1084
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    07

    JUBILANT PHARMOVA LIMITED Nanjangud...

    India
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    Not Confirmed
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    JUBILANT PHARMOVA LIMITED Nanjangud...

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    Cetirizine Dihydrochloride

    Certificate Number : R1-CEP 2007-114 - Rev 05

    Status : Valid

    Issue Date : 2022-08-23

    Type : Chemical

    Substance Number : 1084

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    PRAVEEN LABORATORIES PRIVATE LIMITE...

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    CEP 2021-438 - Rev 00
    Valid
    Chemical
    2024-05-24
    1084
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    PRAVEEN LABORATORIES PRIVATE LIMITE...

    India
    PEGS Boston Summit
    Not Confirmed
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    PRAVEEN LABORATORIES PRIVATE LIMITE...

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    Cetirizine Dihydrochloride

    Certificate Number : CEP 2021-438 - Rev 00

    Status : Valid

    Issue Date : 2024-05-24

    Type : Chemical

    Substance Number : 1084

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    SOLARA ACTIVE PHARMA SCIENCES LIMIT...

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    Valid
    Chemical
    2018-08-08
    1084
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    09

    SOLARA ACTIVE PHARMA SCIENCES LIMIT...

    India
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    Not Confirmed
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    Cetirizine Dihydrochloride

    Certificate Number : R1-CEP 2001-144 - Rev 06

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    Issue Date : 2018-08-08

    Type : Chemical

    Substance Number : 1084

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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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    Speranexus Co., Ltd.

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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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    Permachem Asia Co., Ltd.

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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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    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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    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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    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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    Cipla

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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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    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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    Glochem Industries

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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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    Ipca Laboratories

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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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    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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    Maps Laboratories Private Limited

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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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    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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    Cetirizine hydrochloride

    Registrant Name : Gukjeon 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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    Cetirizine hydrochloride

    Registrant Name : Eltech Pharmachem Co., Ltd.

    Registration Date : 2026-01-30

    Registration Number : 20050831-40-C-139-01(8)

    Manufacturer Name : Supriya Lifescience Ltd.

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

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    Cetirizine hydrochloride

    Registrant Name : Daeshin Muyak 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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    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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    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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    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 Tal-Khed, Dist-Ratnagiri 415722, Maharash...

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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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    Dr. Reddy's Laboratories

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    Cetirizine hydrochloride

    Registrant Name : Pamire 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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    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 Co-operative Industrial Estate, Bolla...

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    ABOUT THIS PAGE

    Looking for 83881-52-1 / Cetirizine Dihydrochloride API manufacturers, exporters & distributors?

    Cetirizine Dihydrochloride manufacturers, exporters & distributors 1

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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, 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.

    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.

    Cezin Manufacturers

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

    Cezin Suppliers

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

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

    Cezin USDMF

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

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

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

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

    Cezin KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

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

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

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

    Cezin CEP

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

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

    Cezin WC

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

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

    Cezin 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 Cezin as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Cezin GMP

    Cezin 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 Cezin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cezin GMP manufacturer or Cezin GMP API supplier for your needs.

    Cezin CoA

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

    Cezin CoA mostly includes findings from lab analyses of a specific batch. For each Cezin 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.

    Cezin may be tested according to a variety of international standards, such as European Pharmacopoeia (Cezin EP), Cezin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cezin 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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