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Chlorpheniramine Maleate

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 14 USDMF, 2 JDMF, 5 EU WC, 7 KDMF, 13 NDC API, 27 Listed Suppliers, $ API Reference Price

42 API Suppliers
14 USDMF
2 JDMF
5 EU WC
7 KDMF
13 NDC API
27 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

206 FDF Dossiers, 66 FDA Orange Book, 8 Europe, 34 Canada, 26 South Africa, 72 Listed Dossiers

206 FDF Dossiers
66 FDA Orange Book
8 Europe
34 Canada
26 South Africa
72 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 4MG/5ML;5MG/5ML, TABLET;ORAL - 2MG;200MG;30MG, TABLET;ORAL - 4MG;200MG;10MG, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
SOLUTION;ORAL - 4MG/5ML;5MG/5ML
TABLET;ORAL - 2MG;200MG;30MG
TABLET;ORAL - 4MG;200MG;10MG
SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

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relatedExcipients
1 Minakem
2 Evonik
12 Rochem International Inc
23 SPI Pharma
2 Seqens
27 DKSH
3 Pharm-RX Chemical
9 Faran Shimi Pharmaceutical
10 Boai NKY Pharmaceuticals Ltd
17 Gangwal Healthcare
2 Kewpie Corporation
16 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 Capital Farma
4 ACG Worldwide
14 Actylis
3 Aeon Procare
2 Alcedo Pharmachem
11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
37 BASF
1 Bioplus Life Sciences
5 Clariant
14 Corel Pharma Chem
7 DFE Pharma
2 Finar
14 Gangwal Chemicals
11 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
39 Kerry
4 Kima Chemical
6 Lonza Capsugel
22 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
4 Novo Excipients
4 Pharmatrans-Sanaq
10 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
47 Roquette
14 Seppic
8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
3 The Dow Chemical Company
3 Ulanqab Kema New Material
2 Valens Pharmachem
5 Vasa Pharmachem
1 Vertellus
2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

123 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 64 Thickeners and Stabilizers, 54 Direct Compression, 52 Solubilizers, 45 Taste Masking, 43 Controlled & Modified Release, 43 Disintegrants & Superdisintegrants, 35 Topical, 33 Granulation, 33 Parenteral, 33 Film Formers & Plasticizers, 29 Lubricants & Glidants, 23 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 17 Rheology Modifiers, 16 Emulsifying Agents, 13 API Stability Enhancers, 9 Empty Capsules, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

MARKET PLACE

29 APIs, 3 FDF Dossiers

marketPlace
29 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

patents
4 US Patents

REF. STANDARDS & IMPURITIES

1 USP , 8 JP , 1 Others

otherSolutions
1 USP
8 JP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 40

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

206

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

457 RELATED EXCIPIENT COMPANIES

778EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 113-92-8, Chlorphenamine maleate, Neorestamin, Synistamin, Piriton, Chlor-trimeton

Molecular Formula

C₂₀H₂₃ClN₂O₄

Molecular Weight

390.9 g/mol

InChI Key

DBAKFASWICGISY-BTJKTKAUSA-N

FDA UNII

V1Q0O9OJ9Z

A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.

1 2D Structure

Chlorpheniramine Maleate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(Z)-but-2-enedioic acid;3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine

2.1.2 InChI

InChI=1S/C16H19ClN2.C4H4O4/c1-19(2)12-10-15(16-5-3-4-11-18-16)13-6-8-14(17)9-7-13;5-3(6)1-2-4(7)8/h3-9,11,15H,10,12H2,1-2H3;1-2H,(H,5,6)(H,7,8)/b;2-1-

2.1.3 InChI Key

DBAKFASWICGISY-BTJKTKAUSA-N

2.1.4 Canonical SMILES

CN(C)CCC(C1=CC=C(C=C1)Cl)C2=CC=CC=N2.C(=CC(=O)O)C(=O)O

2.1.5 Isomeric SMILES

CN(C)CCC(C1=CC=C(C=C1)Cl)C2=CC=CC=N2.C(=C\C(=O)O)\C(=O)O

2.2 Other Identifiers

2.2.1 UNII

V1Q0O9OJ9Z

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Aller-chlor

2. Antihistaminico Llorens

3. Chlo-amine

4. Chlor-100

5. Chlor-trimeton

6. Chlor-tripolon

7. Chlorphenamine

8. Chlorpheniramine

9. Chlorpheniramine Tannate

10. Chlorpro

11. Chlorprophenpyridamine

12. Chlorspan 12

13. Chlortab-4

14. Cloro-trimeton

15. Efidac 24

16. Kloromin

17. Maleate, Chlorpheniramine

18. Piriton

19. Tannate, Chlorpheniramine

20. Teldrin

2.3.2 Depositor-Supplied Synonyms

1. 113-92-8

2. Chlorphenamine Maleate

3. Neorestamin

4. Synistamin

5. Piriton

6. Chlor-trimeton

7. Antagonate

8. Kloromin

9. Chlorphenamine Hydrogen Maleate

10. Histaspan

11. Pyridamal

12. Efidac

13. Chlorpheniramine (maleate)

14. Nci-c55265

15. Polaronil

16. Chlorphenamine Maleates

17. V1q0o9oj9z

18. Chlorpheniramine Maleate Salt

19. Chlorprophenpyridamine Maleate

20. Chloropheniramine Maleate

21. Chebi:3645

22. 3-(4-chlorophenyl)-n,n-dimethyl-3-(pyridin-2-yl)propan-1-amine Maleate

23. Nsc-756684

24. Chlortrimeton

25. Allerclor

26. Allergin

27. Chlormene

28. Ibioton

29. Lorphen

30. Alunex

31. Dehist

32. Piriex

33. Chlor-tripolon

34. C-meton

35. (z)-but-2-enedioic Acid;3-(4-chlorophenyl)-n,n-dimethyl-3-pyridin-2-ylpropan-1-amine

36. Histadur Dura-tabs

37. Chlor-trimeton Od

38. Pyridamal 100

39. Pyridamal-100

40. Polaronil [german]

41. Carbinoxamide Maleate

42. Chlor-trimeton Allergy

43. Phenalin

44. Chlor-trimeton Injection

45. Histaspan-plus

46. Histaspan-d

47. Medique Chlorphen

48. Dl-chlorpheniramine Maleate

49. Ru-tuss Capsules

50. Smr000466271

51. Chloroprophenpyridamine Maleate

52. Ccris 1418

53. 3-(4-chlorophenyl)-n,n-dimethyl-3-pyridin-2-ylpropan-1-aminium (2z)-3-carboxyprop-2-enoate

54. Chlor-trimeton 12 Hour

55. Efidac 24 Chlorpheniramine Maleate

56. Sr-01000075261

57. M.p. Chlorcaps T.d.

58. Einecs 204-037-5

59. Mfcd00069225

60. Chlorpheniramine Maleate Oros Tablets

61. Unii-v1q0o9oj9z

62. Nasohist

63. Puermin

64. Corfen

65. Lohist

66. Chlor-trimeton Repetabs, Syrup, And Tablets

67. Sine Off

68. Sildec Pe

69. Alka-seltzer Plus

70. Prestwick_57

71. Chlorphenaminemaleate

72. Chlorpheniramine Maleate [usp:jan]

73. Teldrin (tn)

74. (+/-)-chlorpheniramine Maleate Salt

75. Chlorophenaminemaleate

76. Zodryl Ac 25

77. Zodryl Ac 30

78. Zodryl Ac 40

79. Zodryl Ac 50

80. Zodryl Ac 60

81. Zodryl Ac 80

82. Chlor-trimeton (tn)

83. 1-p-chlorophenyl-1-(2-pyridyl)-3-dimethylaminopropane Maleate

84. Dl-2-(p-chloro-alpha-2-(dimethylamino)ethylbenzyl)pyridine Maleate

85. 1-(n,n-dimethylamino)-3-(p-chlorophenyl-3-alpha-pyridyl)propane Maleate

86. 1-(p-chlorphenyl)-1-(2-pyridyl)-3-dimethylaminopropan Maleat [german]

87. 2-(p-chloro-alpha-(2-(dimethylamino)ethyl)benzyl)pyridine Maleate (1:1)

88. Chembl1659

89. (y)-chlorpheniramine Maleate

90. Chlorphenamini Hydrogenomaleas

91. Schembl33357

92. (?)-chlorpheniramine Maleate

93. Mls000758311

94. Mls001148230

95. Mls001424173

96. (+/-)-chlorpheniramine Maleate

97. Hms501n18

98. Hy-b0286a

99. (a+/-)-chlorpheniramine Maleate

100. Amf0009

101. 1-(p-chlorphenyl)-1-(2-pyridyl)-3-dimethylaminopropan Maleat

102. Hms1568g16

103. Hms2051l14

104. Hms2093n19

105. Hms2095g16

106. Hms2230f21

107. Hms2232b23

108. Hms3260f04

109. Hms3712g16

110. Hms3884o10

111. Pharmakon1600-01505530

112. Tox21_500261

113. Ac-267

114. Chlorpheniramine Maleate [mi]

115. Nsc759156

116. S1816

117. Chlorpheniramine Maleate (jp17/usp)

118. Chlorpheniramine Maleate [jan]

119. Akos015951220

120. Chlorphenamine Maleate [mart.]

121. Pyridine, 2-(p-chloro-alpha-(2-(dimethylamino)ethyl)benzyl)-, Maleate (1:1)

122. Ccg-101036

123. Ccg-220117

124. Ccg-221565

125. Chlorphenamine Maleate [who-dd]

126. Lp00261

127. Nc00286

128. Nsc 756684

129. 2-pyridinepropanamine, .gamma.-(4-chlorophenyl)-n,n-dimethyl-, (z)-2-butenedioate (1:1)

130. 2-pyridinepropanamine, Gamma-(4-chlorophenyl)-n,n-dimethyl-, (z)-2-butenedioate (1:1)

131. Chlorpheniramine Maleate [vandf]

132. Chlorpheniramine Maleate [usp-rs]

133. Ncgc00093720-01

134. Ncgc00093720-02

135. Ncgc00260946-01

136. As-13167

137. Smr000653461

138. Chlorphenamine Maleate [ep Monograph]

139. Eu-0100261

140. Sw196372-4

141. Chlorpheniramine Maleate [orange Book]

142. C 3025

143. C07780

144. Chlorpheniramine Maleate [usp Monograph]

145. Contac Component Chlorpheniramine Maleate

146. D00665

147. D70131

148. Drize Component Chlorpheniramine Maleate

149. Ornade Component Chlorpheniramine Maleate

150. Chlorphenamine Hydrogen Maleate [who-ip]

151. Demazin Component Chlorpheniramine Maleate

152. Isoclor Component Chlorpheniramine Maleate

153. ( Inverted Question Mark)-chlorpheniramine Maleate

154. Chlorpheniramine Maleate Component Of Contac

155. Chlorpheniramine Maleate Component Of Drize

156. Chlorpheniramine Maleate Component Of Ornade

157. Triaminic Component Chlorpheniramine Maleate

158. Chlorphenamini Hydrogenomaleas [who-ip Latin]

159. Chlorpheniramine Maleate 100 Microg/ml In Methanol

160. Chlorpheniramine Maleate Component Of Demazin

161. Chlorpheniramine Maleate Component Of Isoclor

162. Sr-01000075261-1

163. Sr-01000075261-9

164. W-108612

165. Chlorpheniramine Maleate Component Of Triaminic

166. Q27106157

167. F2173-0923

168. Codimal-l.a. 12 Component Chlorpheniramine Maleate

169. Advil Allergy Sinus Component Chlorpheniramine Maleate

170. Chlorpheniramine Maleate Component Of Advil Allergy Sinus

171. Chlorpheniramine Maleate Component Of Codimal-l.a. 12

172. (+/-)-chlorpheniramine Maleate Salt >=99% (perchloric Acid Titration)

173. (+/-)-chlorpheniramine Maleate Salt, >=99% (perchloric Acid Titration)

174. [3-(4-chloro-phenyl)-3-pyridin-2-yl-propyl]-dimethyl-amine Maleate

175. Chlorphenamine Maleate, European Pharmacopoeia (ep) Reference Standard

176. 2-(p-chloro-.alpha.-(2-(dimethylamino)ethyl)benzyl)pyridine Maleate (1:1)

177. 2-pyridinepropanamine, Gamma-(4-chlorophenyl)-n,n-dimethyl-, (2z)-2-butenedioate (1:1)

178. Chlorphenamine Maleate (chlorpheniramine Maleate) 1.0 Mg/ml In Methanol (as Free Base)

179. Chlorpheniramine Maleate, Pharmaceutical Secondary Standard; Certified Reference Material

180. Chlorpheniramine Maleate, United States Pharmacopeia (usp) Reference Standard

181. Chlorpheniramine Maleate Salt Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

2.3.3 Other Synonyms

1. Chlorpheniaramine Maleate

2. Chloropheniramine Maleate

3. Chlorphenamine Maleate

2.4 Create Date

2005-03-27

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₃ClN₂O₄
Molecular Weight	390.9 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	7
Exact Mass	390.1346349 g/mol
Monoisotopic Mass	390.1346349 g/mol
Topological Polar Surface Area	90.7 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	368
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Chlorpheniramine maleate
Drug Label	Ed Chlortan Tablets are yellow, round, plain bottom, debossed "PH above 012" on top....
Active Ingredient	Chlorpheniramine maleate
Dosage Form	Tablet, extended release
Route	Oral
Strength	12mg
Market Status	Over the Counter
Company	Avanthi

2 of 2
Drug Name	Chlorpheniramine maleate
Drug Label	Ed Chlortan Tablets are yellow, round, plain bottom, debossed "PH above 012" on top....
Active Ingredient	Chlorpheniramine maleate
Dosage Form	Tablet, extended release
Route	Oral
Strength	12mg
Market Status	Over the Counter
Company	Avanthi

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

Antipruritics

Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

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]

API SUPPLIERS

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USDMF

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JDMF

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EU WC

01

Supriya Lifescience

India

DCAT Week

Attending

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

Contact Supplier

India

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Digital Content

Chlorpheniramine Maleate (BP, EP, USP)

Date of Issue : 2022-06-29

Valid Till : 2025-07-02

Written Confirmation Number : WC-0218

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

02

Harika Drugs

India

PharmaVenue

Not Confirmed

Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.

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India

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Digital Content

Chlorpheniramine Maleate (Ph. Eur.)

Date of Issue : 2022-07-27

Valid Till : 2025-07-29

Written Confirmation Number : WC-0179

Address of the Firm : Sy.No.165/A & 165/E, Gummadidala Village, Medak Dist,Talangana State, India

03

Auro Laboratories

India

PharmaVenue

Not Confirmed

04

Keshava Organics

India

PharmaVenue

Not Confirmed

05

R L Fine Chem

India

PharmaVenue

Not Confirmed

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API Reference Price

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SOCIETY ROAD,JOGESHWARI (E)","city":"MUMBAI ,MAHARASHTRA","supplier":"E-PHARMA TRENTO S.P.A.","supplierCountry":"INDIA","foreign_port":"","customer":"SUPRIYA LIFESCIENCE","customerCountry":"INDIA","quantity":"24.00","actualQuantity":"24","unit":"KGS","unitRateFc":"74","totalValueFC":"2211.2","currency":"EUR","unitRateINR":"6775.9","date":"26-Jun-2021","totalValueINR":"162621.62","totalValueInUsd":"2211.2","indian_port":"JNPT","hs_no":"29333990","bill_no":"4462050","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"PRABHAS PLOT NO.9,FLAT NO.4,H.F. SOCIETY ROAD,JOGESHWARI (E)"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648492200,"product":"CHLORPHENIRAMINE MALEATE EP P\/O NO 4540008051","address":"NO.49D, BOMMASANDRA INDUSTRIAL AREA, ANEKAL TQ. 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CORONEL ARMANDO RUBENS STORINO,2750 BAIRRO ALGODAO DOCE- POUSO ALEGRE MG Brazil","customerAddress":"PLOT NO. : T-100, MIDC-TARAPUR,"}]

Number of Transactions

Total Quantity (KGS)

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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML

USFDA APPLICATION NUMBER - 204307

DOSAGE - TABLET;ORAL - 2MG;200MG;30MG

USFDA APPLICATION NUMBER - 21441

DOSAGE - TABLET;ORAL - 4MG;200MG;10MG

USFDA APPLICATION NUMBER - 22113

DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22439

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 7638

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 7638

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ABOUT THIS PAGE

Chlorpheniramine Maleate Manufacturers

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

Chlorpheniramine Maleate Suppliers

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

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

Chlorpheniramine Maleate USDMF

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

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

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

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

Chlorpheniramine Maleate KDMF

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

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

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

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

Chlorpheniramine Maleate WC

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

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

Chlorpheniramine Maleate 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 Chlorpheniramine Maleate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Chlorpheniramine Maleate GMP

Chlorpheniramine Maleate 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 Chlorpheniramine Maleate 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 Chlorpheniramine Maleate GMP manufacturer or Chlorpheniramine Maleate GMP API supplier for your needs.

Chlorpheniramine Maleate CoA

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

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

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

42 API Suppliers

14 USDMF

2 JDMF

5 EU WC

7 KDMF

13 NDC API

27 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

206 FDF Dossiers

66 FDA Orange Book

8 Europe

34 Canada

26 South Africa

72 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 4MG/5ML;5MG/5ML

TABLET;ORAL - 2MG;200MG;30MG

TABLET;ORAL - 4MG;200MG;10MG

SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons