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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
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
1. Prestalia
| Molecular Weight | 567.1 g/mol |
|---|---|
| Molecular Formula | C26H31ClN2O8S |
| 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 Ų |
| 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 |
| 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 |
Treatment of systemic arterial hypertension in cats.
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.)
QC08CA01
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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
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 20MG B...DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 40MG B...DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 80MG B...DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG ...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG ...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG ...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 10MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 20MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 40MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 80MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE
USFDA APPLICATION NUMBER - 21540
DOSAGE - TABLET;ORAL - EQ 10MG BASE;160MG
USFDA APPLICATION NUMBER - 21990
DOSAGE - TABLET;ORAL - EQ 10MG BASE;320MG
USFDA APPLICATION NUMBER - 21990
DOSAGE - TABLET;ORAL - EQ 5MG BASE;160MG
USFDA APPLICATION NUMBER - 21990
DOSAGE - TABLET;ORAL - EQ 5MG BASE;320MG
USFDA APPLICATION NUMBER - 21990
DOSAGE - TABLET;ORAL - EQ 10MG BASE;20MG
USFDA APPLICATION NUMBER - 22100
DOSAGE - TABLET;ORAL - EQ 10MG BASE;40MG
USFDA APPLICATION NUMBER - 22100
DOSAGE - TABLET;ORAL - EQ 5MG BASE;20MG
USFDA APPLICATION NUMBER - 22100
DOSAGE - TABLET;ORAL - EQ 5MG BASE;40MG
USFDA APPLICATION NUMBER - 22100
DOSAGE - TABLET;ORAL - EQ 10MG BASE;12.5MG;16...DOSAGE - TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;160M...DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;160MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;320M...DOSAGE - TABLET;ORAL - EQ 10MG BASE;25MG;320MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160...DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG
USFDA APPLICATION NUMBER - 22314
DOSAGE - TABLET;ORAL - EQ 5MG BASE;25MG;160MG
USFDA APPLICATION NUMBER - 22314
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
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
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
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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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.
A Prestalia manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestalia, including repackagers and relabelers. The FDA regulates Prestalia manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestalia 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 Prestalia manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prestalia supplier is an individual or a company that provides Prestalia active pharmaceutical ingredient (API) or Prestalia finished formulations upon request. The Prestalia suppliers may include Prestalia API manufacturers, exporters, distributors and traders.
click here to find a list of Prestalia suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prestalia DMF (Drug Master File) is a document detailing the whole manufacturing process of Prestalia active pharmaceutical ingredient (API) in detail. Different forms of Prestalia DMFs exist exist since differing nations have different regulations, such as Prestalia USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prestalia DMF submitted to regulatory agencies in the US is known as a USDMF. Prestalia USDMF includes data on Prestalia's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prestalia USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prestalia suppliers with USDMF on PharmaCompass.
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 Prestalia Drug Master File in Japan (Prestalia JDMF) empowers Prestalia 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 Prestalia JDMF during the approval evaluation for pharmaceutical products. At the time of Prestalia 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 Prestalia suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Prestalia Drug Master File in Korea (Prestalia KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestalia. The MFDS reviews the Prestalia KDMF as part of the drug registration process and uses the information provided in the Prestalia KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prestalia 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 Prestalia API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prestalia suppliers with KDMF on PharmaCompass.
A Prestalia CEP of the European Pharmacopoeia monograph is often referred to as a Prestalia Certificate of Suitability (COS). The purpose of a Prestalia CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prestalia EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prestalia to their clients by showing that a Prestalia CEP has been issued for it. The manufacturer submits a Prestalia CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prestalia CEP holder for the record. Additionally, the data presented in the Prestalia CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prestalia DMF.
A Prestalia CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prestalia 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 Prestalia suppliers with CEP (COS) on PharmaCompass.
A Prestalia written confirmation (Prestalia WC) is an official document issued by a regulatory agency to a Prestalia manufacturer, verifying that the manufacturing facility of a Prestalia active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prestalia APIs or Prestalia finished pharmaceutical products to another nation, regulatory agencies frequently require a Prestalia WC (written confirmation) as part of the regulatory process.
click here to find a list of Prestalia suppliers with Written Confirmation (WC) on PharmaCompass.
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 Prestalia as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prestalia API and other APIs are published in this directory by the FDA.
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 Prestalia 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.
The NDC directory also contains data on finished compounded human drug products that contain Prestalia and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prestalia NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prestalia suppliers with NDC on PharmaCompass.
Prestalia 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 Prestalia 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 Prestalia GMP manufacturer or Prestalia GMP API supplier for your needs.
A Prestalia CoA (Certificate of Analysis) is a formal document that attests to Prestalia's compliance with Prestalia specifications and serves as a tool for batch-level quality control.
Prestalia CoA mostly includes findings from lab analyses of a specific batch. For each Prestalia 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.
Prestalia may be tested according to a variety of international standards, such as European Pharmacopoeia (Prestalia EP), Prestalia JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prestalia USP).
