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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


API Reference Price

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EUR (REIMPORT SHIPMENT - EXPORTED VIDE SB NO: 1535434, DT: 20-05-2022, INV NO: SI3622120562)","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"PT-SRI AMAN CORPORINDO","supplierCountry":"INDIA","foreign_port":"JAKARTA SOEKARNO-HA","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"149.19","actualQuantity":"149.19","unit":"KGS","unitRateFc":"75","totalValueFC":"12953.4","currency":"USD","unitRateINR":"7207.2","date":"04-Sep-2023","totalValueINR":"1075235.37","totalValueInUsd":"12953.4","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7672506","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JAKARTA SOEKARNO-HA","supplierAddress":"JL.OUTER RINGROAD MUTIARA TAMANPALEM BLOK D8 NO . 63A &65 JAKARTABARAT 11730 ID","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704479400,"product":"AMLODIPINE BESILATE BATCH NO. 22AD217 (REJECTED QTY -REIMPORT)","address":"CADILA CORPORATE CAMPUS","city":"AHMEDABAD, GUJARAT","supplier":"BIOTEST LIMITED","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"CADILA PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"65.5","totalValueFC":"18498.8","currency":"EURO","unitRateINR":"6149.9","date":"06-Jan-2024","totalValueINR":"1537470.75","totalValueInUsd":"18498.8","indian_port":"Ahmedabad ICD","hs_no":"29333929","bill_no":"9555017","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TRUST COMPANY COMPLEX, AJELTAKEISLAND,MAJURO REPUBLIC OF THEMARSHALL ISALANDS MH 96960 MARSHALL ISLANDS","customerAddress":"CADILA CORPORATE CAMPUS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704479400,"product":"AMLODIPINE BESILATE BATCH NO.23AD065,23AD073,074,075,076,078(REJECTED QTY - REIMPORT)","address":"CADILA CORPORATE CAMPUS","city":"AHMEDABAD, GUJARAT","supplier":"BIOTEST LIMITED","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"CADILA PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"63","totalValueFC":"106756.7","currency":"EURO","unitRateINR":"5915.2","date":"06-Jan-2024","totalValueINR":"8872731.96","totalValueInUsd":"106756.7","indian_port":"Ahmedabad ICD","hs_no":"29333929","bill_no":"9555017","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TRUST COMPANY COMPLEX, AJELTAKEISLAND,MAJURO REPUBLIC OF THEMARSHALL ISALANDS MH 96960 MARSHALL ISLANDS","customerAddress":"CADILA CORPORATE CAMPUS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718821800,"product":"AMLODIPINE BESILATE PH.EUR,BATCH NO:AL23050061(EXP VIDE SB NO: 1646846,DT:09-06-2023,EXP INV NO:SI3623120800\/31-05-2023)","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"NOVARTIS PHARMA AG","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"502.78","actualQuantity":"502.78","unit":"KGS","unitRateFc":"225","totalValueFC":"114237.5","currency":"USD","unitRateINR":"18967.5","date":"20-Jun-2024","totalValueINR":"9536479.65","totalValueInUsd":"114237.5","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"4085697","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BASLE","supplierAddress":"LICHTSTRASSE 35CH-4056 BASELSDNF CH","customerAddress":"7-2-A2, HETERO CORPORATE,"}]
04-Jan-2022
30-Apr-2025
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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.

Amlodipine Besilate Manufacturers

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

Amlodipine Besilate Suppliers

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

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

Amlodipine Besilate USDMF

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

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

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

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

Amlodipine Besilate KDMF

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

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

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

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

Amlodipine Besilate CEP

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

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

Amlodipine Besilate WC

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

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

Amlodipine Besilate 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 Amlodipine Besilate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Amlodipine Besilate GMP

Amlodipine Besilate 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 Amlodipine Besilate 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 Amlodipine Besilate GMP manufacturer or Amlodipine Besilate GMP API supplier for your needs.

Amlodipine Besilate CoA

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

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

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