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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]

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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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Certificate Number : CEP 2009-349 - Rev 02

Status : Valid

Issue Date : 2024-10-16

Type : Chemical

Substance Number : 1084

Granules India

06

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

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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07

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

Certificate Number : R1-CEP 2000-081 - Rev 07

Status : Valid

Issue Date : 2019-08-09

Type : Chemical

Substance Number : 1084

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SA","customerCountry":"SPAIN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1100","totalValueFC":"5200.6","currency":"USD","unitRateINR":89035.800000000003,"date":"19-Apr-2025","totalValueINR":"445179","totalValueInUsd":"5200.6","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"1095736","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE, HYDERABAD-AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745346600,"product":"DRUGS: CETIRIZINE DIHYDROCHLORIDE \/ CETIRIZINE HYDROCHLORIDE PH.EUR.","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"IPCA LABORATORIES LIMITED","supplierCountry":"INDIA","foreign_port":"DUBLIN","customer":"TO ORDER 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03-Jan-2022
24-Apr-2025
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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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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, 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.

Riztec Manufacturers

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

Riztec Suppliers

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

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

Riztec USDMF

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

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

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

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

Riztec KDMF

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

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

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

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

Riztec CEP

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

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

Riztec WC

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

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

Riztec 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 Riztec as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Riztec GMP

Riztec 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 Riztec 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 Riztec GMP manufacturer or Riztec GMP API supplier for your needs.

Riztec CoA

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

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

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