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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

Amlodipine Besylate
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 Weight 567.1 g/mol
Molecular Formula C26H31ClN2O8S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count10
Rotatable Bond Count11
Exact Mass566.1489648 g/mol
Monoisotopic Mass566.1489648 g/mol
Topological Polar Surface Area163 Ų
Heavy Atom Count38
Formal Charge0
Complexity830
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameAmlodipine besylate
PubMed HealthAmlodipine (By mouth)
Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
Drug LabelAmlodipine 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 IngredientAmlodipine besylate
Dosage FormTablet
RouteOral
Strengtheq 5mg base; eq 2.5mg base; eq 10mg base
Market StatusPrescription
CompanyWatson 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 NameNorvasc
Drug LabelNORVASC 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 IngredientAmlodipine besylate
Dosage FormTablet
RouteOral
Strengtheq 5mg base; eq 2.5mg base; eq 10mg base
Market StatusPrescription
CompanyPfizer

3 of 4  
Drug NameAmlodipine besylate
PubMed HealthAmlodipine (By mouth)
Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
Drug LabelAmlodipine 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 IngredientAmlodipine besylate
Dosage FormTablet
RouteOral
Strengtheq 5mg base; eq 2.5mg base; eq 10mg base
Market StatusPrescription
CompanyWatson 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 NameNorvasc
Drug LabelNORVASC 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 IngredientAmlodipine besylate
Dosage FormTablet
RouteOral
Strengtheq 5mg base; eq 2.5mg base; eq 10mg base
Market StatusPrescription
CompanyPfizer

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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04-Jan-2022
30-Apr-2025
KGS
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DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 20MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE

USFDA APPLICATION NUMBER - 21540

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 40MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE

USFDA APPLICATION NUMBER - 21540

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 80MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

USFDA APPLICATION NUMBER - 21540

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;160MG

USFDA APPLICATION NUMBER - 21990

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;320MG

USFDA APPLICATION NUMBER - 21990

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;160MG

USFDA APPLICATION NUMBER - 21990

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;320MG

USFDA APPLICATION NUMBER - 21990

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

USFDA APPLICATION NUMBER - 22100

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

USFDA APPLICATION NUMBER - 22100

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

USFDA APPLICATION NUMBER - 22100

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

USFDA APPLICATION NUMBER - 22100

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;12.5MG;16...DOSAGE - TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG

USFDA APPLICATION NUMBER - 22314

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;160M...DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;160MG

USFDA APPLICATION NUMBER - 22314

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;320M...DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;320MG

USFDA APPLICATION NUMBER - 22314

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160...DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG

USFDA APPLICATION NUMBER - 22314

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;25MG;160MG

USFDA APPLICATION NUMBER - 22314

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;40MG **Fe...DOSAGE - TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22401

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;80MG **Fe...DOSAGE - TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22401

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;40MG **Fed...DOSAGE - TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22401

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;80MG **Fed...DOSAGE - TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22401

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ABOUT THIS PAGE

Looking for 111470-99-6 / Amlodipine Besylate API manufacturers, exporters & distributors?

Amlodipine Besylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Amlodipine Besylate 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 Amlodipine Besylate manufacturer or Amlodipine Besylate supplier for your needs.

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

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

API | Excipient name

Amlodipine Besylate

Synonyms

111470-99-6, Amlodipine besilate, Amlodipine benzenesulfonate, Antacal, Monopina, Istin

Cas Number

111470-99-6

Unique Ingredient Identifier (UNII)

864V2Q084H

About Amlodipine Besylate

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

Antacal Manufacturers

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

Antacal Suppliers

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

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

Antacal USDMF

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

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

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

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

Antacal KDMF

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

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

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

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

Antacal CEP

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

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

Antacal WC

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

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

Antacal 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 Antacal as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Antacal GMP

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

Antacal CoA

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

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

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