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ACTIVE PHARMA INGREDIENTS

111 API Suppliers, 41 USDMF, 44 CEP/COS, 25 JDMF, 26 EU WC, 91 KDMF, 27 NDC API, 55 Listed Suppliers, $ API Reference Price

111 API Suppliers
41 USDMF
44 CEP/COS
25 JDMF
26 EU WC
91 KDMF
27 NDC API
55 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

763 FDF Dossiers, 424 FDA Orange Book, 47 Europe, 134 Canada, 28 South Africa, 130 Listed Dossiers

763 FDF Dossiers
424 FDA Orange Book
47 Europe
134 Canada
28 South Africa
130 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;14MG, TABLET;ORAL - EQ 2.5MG BASE;3.5MG, TABLET;ORAL - EQ 5MG BASE;7MG, TABLET;ORAL - EQ 10MG BASE;200MG, TABLET;ORAL - EQ 2.5MG BASE;200MG, TABLET;ORAL - EQ 5MG BASE;200MG, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;20MG, TABLET;ORAL - EQ 10MG BASE;40MG, TABLET;ORAL - EQ 5MG BASE;20MG, TABLET;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 2.5MG BASE
TABLET;ORAL - EQ 5MG BASE
CAPSULE;ORAL - EQ 10MG BASE;20MG
CAPSULE;ORAL - EQ 10MG BASE;40MG
CAPSULE;ORAL - EQ 2.5MG BASE;10MG
CAPSULE;ORAL - EQ 5MG BASE;10MG
CAPSULE;ORAL - EQ 5MG BASE;20MG
CAPSULE;ORAL - EQ 5MG BASE;40MG
TABLET;ORAL - EQ 10MG BASE;14MG
TABLET;ORAL - EQ 2.5MG BASE;3.5MG
TABLET;ORAL - EQ 5MG BASE;7MG
TABLET;ORAL - EQ 10MG BASE;200MG
TABLET;ORAL - EQ 2.5MG BASE;200MG
TABLET;ORAL - EQ 5MG BASE;200MG
TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE
TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE
TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE
TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE
TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE
TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE
TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE
TABLET;ORAL - EQ 10MG BASE;160MG
TABLET;ORAL - EQ 10MG BASE;320MG
TABLET;ORAL - EQ 5MG BASE;160MG
TABLET;ORAL - EQ 5MG BASE;320MG
TABLET;ORAL - EQ 10MG BASE;20MG
TABLET;ORAL - EQ 10MG BASE;40MG
TABLET;ORAL - EQ 5MG BASE;20MG
TABLET;ORAL - EQ 5MG BASE;40MG
TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG
TABLET;ORAL - EQ 10MG BASE;25MG;160MG
TABLET;ORAL - EQ 10MG BASE;25MG;320MG
TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG
TABLET;ORAL - EQ 5MG BASE;25MG;160MG
TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 21 SPI Pharma, 2 Seqens, 19 DKSH, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 35 BASF, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

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

EXCIPIENTS BY APPLICATIONS

110 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 54 Direct Compression, 47 Disintegrants & Superdisintegrants, 43 Thickeners and Stabilizers, 37 Solubilizers, 35 Controlled & Modified Release, 33 Lubricants & Glidants, 32 Granulation, 27 Topical, 24 Parenteral, 24 Film Formers & Plasticizers, 22 Co-Processed Excipients, 21 Chewable & Orodispersible Aids, 19 Taste Masking, 13 Emulsifying Agents, 10 API Stability Enhancers, 10 Rheology Modifiers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

media
5 DATA COMPILATION #PharmaFlow
41 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 40 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
6 US Medicaid Prescriptions
40 Finished Drug Prices
1 Annual Reports

MARKET PLACE

35 APIs, 7 FDF Dossiers

marketPlace
35 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

33 US Patents, 6 Health Canada Patents

patents
33 US Patents
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM , 1 USP , 7 JP , 1 Others

otherSolutions
5 EDQM
1 USP
7 JP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

111

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 116

MARKET PLACE

API

FDF

6INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

763

FDF Dossiers

424

FDA Orange Book

Europe

134

Canada

Australia

South Africa

130

Listed Dossiers

3DRUGS 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)

352,282,142

Annual Reports (USD Million)

1,396

Finished Drug Prices

369 RELATED EXCIPIENT COMPANIES

647EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 111470-99-6, Amlodipine besilate, Amlodipine benzenesulfonate, Antacal, Monopina, Istin

Molecular Formula

C₂₆H₃₁ClN₂O₈S

Molecular Weight

567.1 g/mol

InChI Key

ZPBWCRDSRKPIDG-UHFFFAOYSA-N

FDA UNII

864V2Q084H

A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.

1 2D Structure

Amlodipine Besylate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

benzenesulfonic acid;3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

2.1.2 InChI

InChI=1S/C20H25ClN2O5.C6H6O3S/c1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21;7-10(8,9)6-4-2-1-3-5-6/h5-8,17,23H,4,9-11,22H2,1-3H3;1-5H,(H,7,8,9)

2.1.3 InChI Key

ZPBWCRDSRKPIDG-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCOC(=O)C1=C(NC(=C(C1C2=CC=CC=C2Cl)C(=O)OC)C)COCCN.C1=CC=C(C=C1)S(=O)(=O)O

2.2 Other Identifiers

2.2.1 UNII

864V2Q084H

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Amlodipine

2. Amlodipine Maleate

3. Amlodipine Maleate (1:1)

4. Amlodipine, (+-)-isomer

5. Amlodipine, (+-)-isomer, Maleate (1:1)

6. Amlodipine, (r)-isomer

7. Amlodipine, (s)-isomer, Maleate (1:1)

8. Amlodis

9. Amlor

10. Astudal

11. Istin

12. Norvasc

2.3.2 Depositor-Supplied Synonyms

1. 111470-99-6

2. Amlodipine Besilate

3. Amlodipine Benzenesulfonate

4. Antacal

5. Monopina

6. Istin

7. Amlodipine (besylate)

8. Amdepin

9. Amdipin

10. Amlodin

11. Pelmec

12. 3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate

13. Lodipressin

14. Amlor

15. Amlodipine (as Besilate)

16. Nsc-758922

17. (s)-amlodipine;levoamlodipine

18. Amlodipine Besylate (norvasc)

19. Chebi:2669

20. Cardiorex

21. Uk-48,340-26

22. 111470-99-6 (besylate)

23. 864v2q084h

24. 3,5-pyridinedicarboxylic Acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl Ester, (+-)-, Monobenzenesulfonate

25. Ncgc00095835-01

26. Amlogard

27. Amlopin

28. Amlosyn

29. Astudar

30. Cordarene

31. Myodura

32. Norlopin

33. Norvask

34. Tensivask

35. Amcard

36. Norvas

37. Terloc

38. Norvasc (tn)

39. Uk-48340-26

40. (s)-amlodipine Besylate;levoamlodipine Besylate

41. Dsstox_cid_23909

42. Dsstox_rid_80087

43. Dsstox_gsid_43909

44. Benzenesulfonic Acid;3-o-ethyl 5-o-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

45. Stamlo

46. Amlodipine Besylate [usan]

47. Cas-111470-99-6

48. C20h25cln2o5.c6h6o3s

49. Ncgc00165957-04

50. Amlodipine 100 Microg/ml In Acetonitrile

51. Unii-864v2q084h

52. Amlodipine Besylate [usan:usp]

53. Uk 48340-26

54. 3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate

55. Mfcd00887594

56. Norliqva

57. Spectrum_000573

58. Amlodipine Benzenesulphonate

59. Amlodipine Besylate (usp)

60. Amlodipine Besylate- Bio-x

61. Amlodipine Besilate (jp17)

62. Schembl41282

63. Kbioss_001053

64. 3-ethyl 5-methyl (+-)-2-((2-aminoethoxy)methyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, Monobenzenesulfonate

65. Mls001361394

66. Spectrum1505202

67. Chembl1200402

68. Chembl3193637

69. Chembl3207778

70. Dtxsid2043909

71. Hy-b0317b

72. Kbio2_001053

73. Kbio2_003621

74. Kbio2_006189

75. Amlodipine Besilate [jan]

76. Amlodipine Besylate [hsdb]

77. Hms2094e13

78. Hms2232d22

79. Hms2235b19

80. Hms3269b19

81. Hms3372o18

82. Hms3373f15

83. Hms3413h11

84. Hms3677h11

85. Hms3884m10

86. Pharmakon1600-01505202

87. Amlodipine Besylate [vandf]

88. Amlodipine Besilate [mart.]

89. Bcp21993

90. Tox21_111525

91. Tox21_113476

92. Ac-079

93. Amlodipine Besilate [who-dd]

94. Amlodipine Besylate [usp-rs]

95. Ccg-39531

96. Nsc758922

97. S1813

98. Akos001260256

99. Akos016340493

100. Amlodipine Besylate [ema Epar]

101. Amlodipine Besylate, >=98% (hplc)

102. Bcp9000059

103. Cs-3988

104. Ks-1029

105. Nsc 758922

106. Amlodipine Benzenesulfonate [mi]

107. Amlodipine Besylate [orange Book]

108. Azor Component Amlodipine Besylate

109. 3,5-pyridinedicarboxylic Acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl-5-methyl Ester, Monobenzenesulfonate

110. Amlodipine Besilate [ep Monograph]

111. Amlodipine Besylate [usp Impurity]

112. Ba164162

113. Smr000875356

114. Amlodipine Besylate [usp Monograph]

115. Caduet Component Amlodipine Besylate

116. Dafiro Component Amlodipine Besilate

117. Lotrel Component Amlodipine Besylate

118. Amlessa Component Amlodipine Besylate

119. Copalia Component Amlodipine Besylate

120. Exforge Component Amlodipine Besilate

121. Exforge Component Amlodipine Besylate

122. Imprida Component Amlodipine Besilate

123. Onduarp Component Amlodipine Besylate

124. Tekamlo Component Amlodipine Besylate

125. Twynsta Component Amlodipine Besylate

126. Amlodipine Besylate Component Of Azor

127. Consensi Component Amlodipine Besylate

128. Ft-0622301

129. Sw198880-2

130. Amlodipine Besilate Component Of Dafiro

131. Amlodipine Besylate Component Of Caduet

132. Amlodipine Besylate Component Of Lotrel

133. Amturnide Component Amlodipine Besylate

134. Tribenzor Component Amlodipine Besylate

135. Vu0244594-3

136. Amlodipine Besilate Component Of Exforge

137. Amlodipine Besylate Component Of Copalia

138. Amlodipine Besylate Component Of Exforge

139. Amlodipine Besylate Component Of Onduarp

140. Amlodipine Besylate Component Of Tekamlo

141. Amlodipine Besylate Component Of Twynsta

142. D00615

143. Dafiro-hct Component Amlodipine Besilate

144. F17340

145. Amlodipine Besylate [ema Epar Veterinary]

146. Amlodipine Besylate Component Of Amturnide

147. Amlodipine Besylate Component Of Consensi

148. Amlodipine Besylate Component Of Tribenzor

149. Exforge Hct Component Amlodipine Besylate

150. Exforge-hct Component Amlodipine Besilate

151. Imprida-hct Component Amlodipine Besilate

152. 470a996

153. A802368

154. Amlodipine Besilate Component Of Dafiro-hct

155. Amlodipine Besilate Component Of Exforge-hct

156. Amlodipine Besilate Component Of Imprida-hct

157. Amlodipine Besylate Component Of Exforge Hct

158. Q-101934

159. Q-200627

160. Sr-05000001461-2

161. Q27105760

162. F6170-0024

163. Amlodipine Besylate, European Pharmacopoeia (ep) Reference Standard

164. Amlodipine Besylate, United States Pharmacopeia (usp) Reference Standard

165. Amlodipine Besylate, Pharmaceutical Secondary Standard; Certified Reference Material

166. Amlodipine For Peak Identification, European Pharmacopoeia (ep) Reference Standard

167. (+/-)-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate Monobenzenesulfonate

168. 2-(2-aminoethoxy)methyl-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic Acid 3-ethyl 5-methyl Ester Benzenesulfona

169. 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic Acid O3-ethyl Ester O5-methyl Ester; Benzenesulfonic Acid

170. 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarbo Xylic Acid 3-ethyl 5-methyl Ester Benzenesulfonate

171. 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic Acid 3-ethyl 5-methyl Ester Benzenesulfonate

172. 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine Benzenesulfonate

173. 3,5-pyridinedicarboxylic Acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl Ester, (+/-)-, Monobenzenesulfonate

174. 3,5-pyridinedicarboxylic Acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl Ester, (+/-)-, Monobenzenesulphonate

175. 3,5-pyridinedicarboxylic Acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl Ester, Benzenesulfonate (1:1)

176. 3-ethyl 5-methyl (+/-)-2-((2-aminoethoxy)methyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, Monobenzenesulfonate

177. 3-ethyl 5-methyl (+/-)-2-((2-aminoethoxy)methyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, Monobenzenesulphonate

178. 3-ethyl 5-methyl 2-(2-aminoethoxy)methyl-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate

179. 3-ethyl 5-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methylpyridine-3,5-dicarboxylate Monobenzenesulphonate

180. 3-ethyl5-methyl2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylatebenzenesulfonate

181. Benzenesulfonic Acid; O3-ethyl O5-methyl 2-(2-azanylethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

2.3.3 Other Synonyms

1. Prestalia

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₁ClN₂O₈S
Molecular Weight	567.1 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	11
Exact Mass	566.1489648 g/mol
Monoisotopic Mass	566.1489648 g/mol
Topological Polar Surface Area	163 Å²
Heavy Atom Count	38
Formal Charge	0
Complexity	830
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Amlodipine besylate
PubMed Health	Amlodipine (By mouth)
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl ()-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarbox...
Active Ingredient	Amlodipine besylate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 2.5mg base; eq 10mg base
Market Status	Prescription
Company	Watson Labs; Wockhardt; Ranbaxy; Amneal Pharms Ny; Upsher Smith; Secan Pharms; Matrix Labs; Epic Pharma; Macleods Pharms; Vivimed Labs; Teva; Apotex; Accord Hlthcare; Vintage; Alkem; Sun Pharm Inds; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupi

2 of 4
Drug Name	Norvasc
Drug Label	NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl ()-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobe...
Active Ingredient	Amlodipine besylate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 2.5mg base; eq 10mg base
Market Status	Prescription
Company	Pfizer

3 of 4
Drug Name	Amlodipine besylate
PubMed Health	Amlodipine (By mouth)
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl ()-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarbox...
Active Ingredient	Amlodipine besylate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 2.5mg base; eq 10mg base
Market Status	Prescription
Company	Watson Labs; Wockhardt; Ranbaxy; Amneal Pharms Ny; Upsher Smith; Secan Pharms; Matrix Labs; Epic Pharma; Macleods Pharms; Vivimed Labs; Teva; Apotex; Accord Hlthcare; Vintage; Alkem; Sun Pharm Inds; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupi

4 of 4
Drug Name	Norvasc
Drug Label	NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl ()-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobe...
Active Ingredient	Amlodipine besylate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 2.5mg base; eq 10mg base
Market Status	Prescription
Company	Pfizer

4.2 Drug Indication

Treatment of systemic arterial hypertension in cats.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

Calcium Channel Blockers

A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Calcium Channel Blocker [EPC]; Cytochrome P450 3A Inhibitors [MoA]; Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]; Calcium Channel Antagonists [MoA]

5.3 ATC Code

QC08CA01

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SANOFI İLAÇ SANAYI VE TICARET A.�...

France

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Amlodipine Besilate

Certificate Number : R1-CEP 2005-052 - Rev 05

Status : Valid

Issue Date : 2021-02-25

Type : Chemical

Substance Number : 1491

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DR. REDDY'S LABORATORIES LIMITED Hy...

India

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Amlodipine Besilate

Certificate Number : R1-CEP 2003-007 - Rev 06

Status : Valid

Issue Date : 2017-08-23

Type : Chemical

Substance Number : 1491

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Hungary

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Amlodipine Besilate, Synthetic Route B

Certificate Number : R1-CEP 2007-185 - Rev 02

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Issue Date : 2016-12-19

Type : Chemical

Substance Number : 1491

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EGIS Pharmaceuticals PLC Budapest H...

Hungary

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Amlodipine Besilate, Synthesis B Process B

Certificate Number : CEP 2023-411 - Rev 00

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Issue Date : 2024-06-14

Type : Chemical

Substance Number : 1491

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Moehs Iberica S.L. Rubi ES

Spain

CPhI WW Frankfurt

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Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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Amlodipine Besilate, M02

Certificate Number : R0-CEP 2021-359 - Rev 02

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Issue Date : 2023-03-23

Type : Chemical

Substance Number : 1491

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Moehs Iberica S.L. Rubi ES

Spain

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Amlodipine Besilate

Certificate Number : R1-CEP 2005-237 - Rev 02

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Issue Date : 2020-06-29

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Substance Number : 1491

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Oman Chemicals And Pharmaceuticals ...

Oman

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Smruthi Organics Limited Solapur IN

India

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MOSES, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"AMLODIPINE BESYLATE","year":"2021","qtr":"Q1","strtotime":1616178600,"product":"RE-IMPORT AMLODIPINE BESYLATE USP (SHIPPING BILL NO-4572671DT-19.08.2020)","address":"HETERO HOUSE, H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD-A.P.","supplier":"BERLIN PHARMACEUTICAL INDUSTRY ","supplierCountry":"INDIA","foreign_port":"","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"91","totalValueFC":"55011.4","currency":"USD","unitRateINR":"6674.9","date":"20-Mar-2021","totalValueINR":"4004910","totalValueInUsd":"55011.4","indian_port":"MADRAS SEA","hs_no":"29333990","bill_no":"3228461","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"HETERO HOUSE, H.NO.8-3-166\/7\/1ERRAGADDA"},{"dataSource":"API Import","activeIngredients":"AMLODIPINE","year":"2021","qtr":"Q2","strtotime":1620844200,"product":"AMLODIPINE BESILATE","address":"MEDREICH HOUSE, NO12\/8,SARASWATHI AMMAL STREET, MARUTHI","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"MEIJI SEIKA PHARMA","supplierCountry":"JAPAN","foreign_port":"TOKYO - NARITA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"421.2","totalValueFC":"85971.9","currency":"USD","unitRateINR":"31486.9","date":"13-May-2021","totalValueINR":"6297388.5","totalValueInUsd":"85971.9","indian_port":"BANGALORE AIR","hs_no":"29183090","bill_no":"3926540","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO - NARITA","supplierAddress":"","customerAddress":"MEDREICH HOUSE, NO12\/8,SARASWATHI AMMAL STREET, MARUTHI"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1623004200,"product":"AMLODIPINE BESYLATE","address":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD","city":"SECUNDERABAD, ANDHRA PRADESH","supplier":"PFIZER INC","supplierCountry":"SINGAPORE","foreign_port":"SINGAPORE","customer":"VIATRIS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"12895.4","totalValueFC":"129663.3","currency":"USD","unitRateINR":"953617.1","date":"07-Jun-2021","totalValueINR":"9536170.49","totalValueInUsd":"129663.3","indian_port":"HYDERABAD AIR","hs_no":"29333990","bill_no":"4230787","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"SINGAPORE","supplierAddress":"","customerAddress":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1626287400,"product":"REIMPORT OF AMLODIPINE BESILATE BP\/EP (PHARMACEUTICAL RAW MATERIAL) (EXPORTED AGAINST SB NO. 8207313 DTD. 28.01.2021)","address":"PLOT NO 7407 , B\/H LYKA LABGIDC ANKLESHWAR","city":"BHARUCH","supplier":"BMP PHARMA TRADING AG","supplierCountry":"INDIA","foreign_port":"","customer":"PRUDENCE PHARMACHEM","customerCountry":"INDIA","quantity":"65.00","actualQuantity":"65","unit":"KGS","unitRateFc":"69","totalValueFC":"5428.9","currency":"USD","unitRateINR":"6224.6","date":"15-Jul-2021","totalValueINR":"404595.7","totalValueInUsd":"5428.9","indian_port":"JNPT","hs_no":"29242190","bill_no":"4693288","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"PLOT NO 7407 , B\/H LYKA LABGIDC ANKLESHWAR"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1651516200,"product":"AMLODIPINE BESILATE","address":"12\/8 SARASWATHI AMMAL STREET MARUTHI SEVA NAGAR Contact No: 9177","city":"BANGALORE KARNATAKA","supplier":"MEIJI SEIKA PHARMA","supplierCountry":"JAPAN","foreign_port":"NA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"383","totalValueFC":"9557.7","currency":"USD","unitRateINR":"29546.9","date":"03-May-2022","totalValueINR":"738672.68","totalValueInUsd":"9557.7","indian_port":"BANGALORE AIR","hs_no":"29333990","bill_no":"8523886","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12\/8 SARASWATHI AMMAL STREET MARUTHI SEVA NAGAR Contact No: 9177"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652034600,"product":"AMLODIPINE BESYLATE (QTY: 1X350 MG,PRICE: USD 257)(FOC)","address":"P.NO. 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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 19787

DOSAGE - TABLET;ORAL - EQ 2.5MG BASE

USFDA APPLICATION NUMBER - 19787

DOSAGE - TABLET;ORAL - EQ 5MG BASE

USFDA APPLICATION NUMBER - 19787

DOSAGE - CAPSULE;ORAL - EQ 10MG BASE;20MG

USFDA APPLICATION NUMBER - 20364

DOSAGE - CAPSULE;ORAL - EQ 10MG BASE;40MG

USFDA APPLICATION NUMBER - 20364

DOSAGE - CAPSULE;ORAL - EQ 2.5MG BASE;10MG

USFDA APPLICATION NUMBER - 20364

DOSAGE - CAPSULE;ORAL - EQ 5MG BASE;10MG

USFDA APPLICATION NUMBER - 20364

DOSAGE - CAPSULE;ORAL - EQ 5MG BASE;20MG

USFDA APPLICATION NUMBER - 20364

DOSAGE - CAPSULE;ORAL - EQ 5MG BASE;40MG

USFDA APPLICATION NUMBER - 20364

DOSAGE - TABLET;ORAL - EQ 10MG BASE;14MG

USFDA APPLICATION NUMBER - 205003

DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;3.5MG

USFDA APPLICATION NUMBER - 205003

DOSAGE - TABLET;ORAL - EQ 5MG BASE;7MG

USFDA APPLICATION NUMBER - 205003

DOSAGE - TABLET;ORAL - EQ 10MG BASE;200MG

USFDA APPLICATION NUMBER - 210045

DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;200MG

USFDA APPLICATION NUMBER - 210045

DOSAGE - TABLET;ORAL - EQ 5MG BASE;200MG

USFDA APPLICATION NUMBER - 210045

DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 10MG B...DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE