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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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    USFDA APPLICATION NUMBER - 21990

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

    USFDA APPLICATION NUMBER - 21990

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    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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    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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    USFDA APPLICATION NUMBER - 22314

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    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**

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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.

    Prestalia Manufacturers

    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.

    Prestalia Suppliers

    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.

    Prestalia USDMF

    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.

    Prestalia 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 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.

    Prestalia KDMF

    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.

    Prestalia CEP

    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.

    Prestalia WC

    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.

    Prestalia 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 Prestalia as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Prestalia 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 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.

    Compounded drug products

    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 GMP

    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.

    Prestalia CoA

    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).

    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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