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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

Chlorpheniramine Maleate
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 Weight 390.9 g/mol
Molecular Formula C20H23ClN2O4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count7
Exact Mass390.1346349 g/mol
Monoisotopic Mass390.1346349 g/mol
Topological Polar Surface Area90.7 Ų
Heavy Atom Count27
Formal Charge0
Complexity368
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameChlorpheniramine maleate
Drug LabelEd Chlortan Tablets are yellow, round, plain bottom, debossed "PH above 012" on top....
Active IngredientChlorpheniramine maleate
Dosage FormTablet, extended release
RouteOral
Strength12mg
Market StatusOver the Counter
CompanyAvanthi

2 of 2  
Drug NameChlorpheniramine maleate
Drug LabelEd Chlortan Tablets are yellow, round, plain bottom, debossed "PH above 012" on top....
Active IngredientChlorpheniramine maleate
Dosage FormTablet, extended release
RouteOral
Strength12mg
Market StatusOver the Counter
CompanyAvanthi

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]

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Contact No: 78313"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676313000,"product":"CHLORPHENIRAMINE MALEATE","address":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL","city":"MEDCHAL-MALKAKGIRI DISTRICT,TELANGA","supplier":"SPERA NEXUS INC","supplierCountry":"JAPAN","foreign_port":"NA","customer":"ALPHAMED FORMULATIONS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"195","totalValueFC":"1953.8","currency":"USD","unitRateINR":"16136.3","date":"14-Feb-2023","totalValueINR":"161362.5","totalValueInUsd":"1953.8","indian_port":"HYDERABAD AIR","hs_no":"29333914","bill_no":"4640581","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694543400,"product":"(RE-IMPORT) CHLORPHENIRAMINE MALEATE EP","address":"4, PODAR CHAMBERS, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA","supplier":"SHANGHAI D\\'ANGELO INDUSTRY COLTD","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"INDOSOL EXPORTS","customerCountry":"INDIA","quantity":"4500.00","actualQuantity":"4500","unit":"KGS","unitRateFc":"17.5","totalValueFC":"79643.5","currency":"USD","unitRateINR":"1469.1","date":"13-Sep-2023","totalValueINR":"6611062.5","totalValueInUsd":"79643.5","indian_port":"JNPT","hs_no":"29333914","bill_no":"7816876","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Room 748,Bld A, No.888 2nd West Huanhu Road,Pudong District,Shanghai 201306 P.R.of China China","customerAddress":"4, PODAR CHAMBERS, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706639400,"product":"REIMPORT FOR PROCESS - CHLORPHENIRAMINE MALEATE USP (VIDE S\/B NO. 4852412 DT. 15.10.2022)(QTY: 12 DRUMS OF 25 KGS)","address":"PLOT NO. : T-100, MIDC-TARAPUR,","city":"DIST - THANE, MAHARASHTRA.","supplier":"CIMED INDUSTRIA SA","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"KESHAVA ORGANICS PVT LTD","customerCountry":"INDIA","quantity":"299.46","actualQuantity":"299.46","unit":"KGS","unitRateFc":"37.3","totalValueFC":"11897.3","currency":"USD","unitRateINR":"3302","date":"31-Jan-2024","totalValueINR":"988805.45","totalValueInUsd":"11897.3","indian_port":"JNPT","hs_no":"29333914","bill_no":"9907557","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTOS","supplierAddress":"AV. CORONEL ARMANDO RUBENS STORINO,2750 BAIRRO ALGODAO DOCE- POUSO ALEGRE MG Brazil","customerAddress":"PLOT NO. : T-100, MIDC-TARAPUR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706639400,"product":"REIMPORT FOR PROCESS - CHLORPHENIRAMINE MALEATE USP (VIDE S\/B NO. 5798946 DT. 29.11.2022)(QTY: 48 DRUMS OF 25 KGS)","address":"PLOT NO. : T-100, MIDC-TARAPUR,","city":"DIST - THANE, MAHARASHTRA.","supplier":"CIMED INDUSTRIA SA","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"KESHAVA ORGANICS PVT LTD","customerCountry":"INDIA","quantity":"1198.65","actualQuantity":"1198.65","unit":"KGS","unitRateFc":"27.5","totalValueFC":"35156.8","currency":"USD","unitRateINR":"2437.7","date":"31-Jan-2024","totalValueINR":"2921937.37","totalValueInUsd":"35156.8","indian_port":"JNPT","hs_no":"29333914","bill_no":"9907557","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTOS","supplierAddress":"AV. CORONEL ARMANDO RUBENS STORINO,2750 BAIRRO ALGODAO DOCE- POUSO ALEGRE MG Brazil","customerAddress":"PLOT NO. : T-100, MIDC-TARAPUR,"}]
06-Jan-2022
30-Apr-2025
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DRUG PRODUCT COMPOSITIONS

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

USFDA APPLICATION NUMBER - 204307

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

USFDA APPLICATION NUMBER - 21441

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

USFDA APPLICATION NUMBER - 22113

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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

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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

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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

Looking for 113-92-8 / Chlorpheniramine Maleate API manufacturers, exporters & distributors?

Chlorpheniramine Maleate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Chlorpheniramine Maleate 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 Chlorpheniramine Maleate manufacturer or Chlorpheniramine Maleate supplier for your needs.

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

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

API | Excipient name

Chlorpheniramine Maleate

Synonyms

113-92-8, Chlorphenamine maleate, Neorestamin, Synistamin, Piriton, Chlor-trimeton

Cas Number

113-92-8

Unique Ingredient Identifier (UNII)

V1Q0O9OJ9Z

About Chlorpheniramine Maleate

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.

Alunex Manufacturers

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

Alunex Suppliers

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

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

Alunex USDMF

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

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

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

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

Alunex KDMF

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

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

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

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

Alunex WC

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

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

Alunex 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 Alunex as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Alunex GMP

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

Alunex CoA

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

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

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