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    Chemistry

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    Also known as: 129722-12-9, Abilify, Abilitat, Opc-14597, Abilify discmelt, Opc 14597
    Molecular Formula
    C23H27Cl2N3O2
    Molecular Weight
    448.4  g/mol
    InChI Key
    CEUORZQYGODEFX-UHFFFAOYSA-N
    FDA UNII
    82VFR53I78
    Aripiprazole
    A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression.
    Aripiprazole is an Atypical Antipsychotic.
    1 2D Structure

    Aripiprazole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-1H-quinolin-2-one
    2.1.2 InChI
    InChI=1S/C23H27Cl2N3O2/c24-19-4-3-5-21(23(19)25)28-13-11-27(12-14-28)10-1-2-15-30-18-8-6-17-7-9-22(29)26-20(17)16-18/h3-6,8,16H,1-2,7,9-15H2,(H,26,29)
    2.1.3 InChI Key
    CEUORZQYGODEFX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CC(=O)NC2=C1C=CC(=C2)OCCCCN3CCN(CC3)C4=C(C(=CC=C4)Cl)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    82VFR53I78
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butyloxy)-3,4-dihydro-2(1h)-quinolinone

    2. Abilify

    3. Aripiprazol

    4. Opc 14597

    5. Opc-14597

    2.3.2 Depositor-Supplied Synonyms

    1. 129722-12-9

    2. Abilify

    3. Abilitat

    4. Opc-14597

    5. Abilify Discmelt

    6. Opc 14597

    7. Opc 31

    8. Aripiprex

    9. Abilify Maintena

    10. Abilify Mycite

    11. Opc-31

    12. 7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-1h-quinolin-2-one

    13. 7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1h)-one

    14. 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril

    15. Nsc-759266

    16. Chembl1112

    17. 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydrocarbostyril

    18. 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-2(1h)-quinolinone

    19. 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1h)-quinolinone

    20. 7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1h)-one

    21. Aripiprazol

    22. Discmelt

    23. Chebi:31236

    24. 82vfr53i78

    25. 129722-12-9 (free Base)

    26. Mfcd00892072

    27. 2(1h)-quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-

    28. 7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one

    29. Ncgc00159510-02

    30. Aripiprazole [usan]

    31. 2(1h)-quinolinone, 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-

    32. Dsstox_cid_26083

    33. Dsstox_rid_81324

    34. Dsstox_gsid_46083

    35. Aripiprazolum

    36. 7-[4-[4-[2,3-bis(chloranyl)phenyl]piperazin-1-yl]butoxy]-3,4-dihydro-1h-quinolin-2-one

    37. 7-{4-[4-(2,3-dichloro-phenyl)-piperazin-1-yl]-butoxy}-3,4-dihydro-1h-quinol In-2-one

    38. Smr000466383

    39. Abilify (tn)

    40. Abilify Maintena Kit

    41. Cas-129722-12-9

    42. Hsdb 7320

    43. Sr-01000759353

    44. Unii-82vfr53i78

    45. Abilify Digital

    46. 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butyloxy)-3,4-dihydro-2(1h)-quinolinone

    47. Aripiprazole [usan:inn:ban]

    48. 7-(4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy)-3,4-dihydrocarbostyril

    49. 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril

    50. Abilify Od

    51. 7-(4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy)-3,4-dihydroquinolin-2(1h)-one

    52. Aripiprazole Depot

    53. 9sc

    54. Aripiprazole Solution

    55. Aripiprazole- Bio-x

    56. Bms-337039

    57. Ks-1030

    58. Aripiprazole (abilify)

    59. Cpd000466383

    60. Aripiprazole-d8 Solution

    61. Abilify Mycite Kit

    62. Aripiprazole [mi]

    63. Aripiprazole [inn]

    64. Aripiprazole [jan]

    65. Gtpl34

    66. Aripiprazole [hsdb]

    67. Aripiprazole-d8(butyl-d8)

    68. Schembl8255

    69. Aripiprazole [vandf]

    70. Aripiprazole [mart.]

    71. Mls000759517

    72. Mls001165779

    73. Mls001195621

    74. Mls001424078

    75. Mls006011892

    76. Aripiprazole [usp-rs]

    77. Aripiprazole [who-dd]

    78. Aripiprazole (jan/usp/inn)

    79. Schembl5335696

    80. Aripiprazole [ema Epar]

    81. Aristada (aripiprazole Lauroxil)

    82. Dtxsid3046083

    83. Schembl12961254

    84. Aripiprazole [orange Book]

    85. Hms2051i18

    86. Hms2089m20

    87. Hms2093f22

    88. Hms2230m18

    89. Hms3373d04

    90. Hms3393i18

    91. Hms3657k13

    92. Hms3715j07

    93. Hms3744a13

    94. Hms3884e18

    95. Pharmakon1600-01505851

    96. Aripiprazole [ep Monograph]

    97. Act03221

    98. Bcp04902

    99. Zinc1851149

    100. Aripiprazole [usp Monograph]

    101. Tox21_111728

    102. Bbl029082

    103. Bdbm50130293

    104. Dl-178

    105. Nsc759266

    106. S1975

    107. Stk625160

    108. Akos005558247

    109. Tox21_111728_1

    110. Ab07660

    111. Ac-1554

    112. Bcp9000317

    113. Ccg-100891

    114. Cs-0766

    115. Db01238

    116. Nc00141

    117. Nsc 759266

    118. Aripiprazole 1.0 Mg/ml In Acetonitrile

    119. Ncgc00159510-03

    120. Ncgc00159510-04

    121. Ncgc00159510-05

    122. Ba164218

    123. Hy-14546

    124. Sy053146

    125. Sbi-0206870.p001

    126. Am20090766

    127. Ft-0600352

    128. Ft-0662278

    129. Ft-0662279

    130. Sw197521-3

    131. A19454

    132. D01164

    133. Ab00639935-09

    134. Ab00639935_10

    135. Ab00639935_11

    136. 722a129

    137. L001339

    138. Q411188

    139. J-005707

    140. Sr-01000759353-4

    141. Sr-01000759353-6

    142. Brd-k70358946-001-06-6

    143. Z1541632800

    144. 7-[4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy]-3,4-dihydro-2(1h)-quinolinone

    145. 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]3,4-dihydro-2(1h)-quinolinone

    146. 7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-quinolin-2(1h)-one

    147. 7-{4-[-4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril

    148. 7-{4-[4-(2,3-dichloro-phenyl)-piperazin-1-yl]-butoxy}-3,4-dihydro-1h-quinolin-2-one

    149. 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3, 4-dihydrocarbostyril

    150. 7-{4-[4-(2,3-dichlorophenyl)piperazino]butoxy}-3,4-dihydro-2(1h)-quinolinone

    151. Aripiprazole; 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydrocarbostyril

    152. 1026778-41-5

    153. 24-29-3

    154. Aripiprazole Solution, 1.0 Mg/ml (50:50 Methanol/water With 1% 1n Hcl), Ampule Of 1 Ml, Certified Reference Material

    155. Aripiprazole Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 448.4 g/mol
    Molecular Formula C23H27Cl2N3O2
    XLogP34.6
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count7
    Exact Mass447.1480325 g/mol
    Monoisotopic Mass447.1480325 g/mol
    Topological Polar Surface Area44.8 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity559
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameAbilify
    PubMed HealthAripiprazole (Injection)
    Drug ClassesAntipsychotic
    Drug LabelAripiprazole is a psychotropic drug that is available as ABILIFY (aripiprazole) Tablets, ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets, ABILIFY (aripiprazole) Oral Solution, and ABILIFY (aripiprazole) Injection, a solution for...
    Active IngredientAripiprazole
    Dosage FormSolution; Injectable; Tablet, orally disintegrating; Tablet
    RouteIntramuscular; Oral
    Strength30mg; 10mg; 5mg; 9.75mg/1.3ml (7.5mg/ml); 15mg; 1mg/ml; 20mg; 2mg
    Market StatusPrescription
    CompanyOtsuka

    2 of 4  
    Drug NameAripiprazole
    PubMed HealthAripiprazole
    Drug ClassesAntipsychotic
    Drug LabelAripiprazole is a psychotropic drug that is available as ABILIFY (aripiprazole) Tablets, ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets, ABILIFY (aripiprazole) Oral Solution, and ABILIFY (aripiprazole) Injection, a solution for...
    Active IngredientAripiprazole
    Dosage FormTablet, orally disintegrating; Tablet
    Routeorally disintegrating; oral
    Strength5mg; 2mg; 30mg; 10mg; 15mg; 20mg
    Market StatusTentative Approval
    CompanyApotex; Alembic Pharms; Torrent Pharms; Zydus Pharms Usa; Barr Labs; Sun Pharma Global

    3 of 4  
    Drug NameAbilify
    PubMed HealthAripiprazole (Injection)
    Drug ClassesAntipsychotic
    Drug LabelAripiprazole is a psychotropic drug that is available as ABILIFY (aripiprazole) Tablets, ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets, ABILIFY (aripiprazole) Oral Solution, and ABILIFY (aripiprazole) Injection, a solution for...
    Active IngredientAripiprazole
    Dosage FormSolution; Injectable; Tablet, orally disintegrating; Tablet
    RouteIntramuscular; Oral
    Strength30mg; 10mg; 5mg; 9.75mg/1.3ml (7.5mg/ml); 15mg; 1mg/ml; 20mg; 2mg
    Market StatusPrescription
    CompanyOtsuka

    4 of 4  
    Drug NameAripiprazole
    PubMed HealthAripiprazole
    Drug ClassesAntipsychotic
    Drug LabelAripiprazole is a psychotropic drug that is available as ABILIFY (aripiprazole) Tablets, ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets, ABILIFY (aripiprazole) Oral Solution, and ABILIFY (aripiprazole) Injection, a solution for...
    Active IngredientAripiprazole
    Dosage FormTablet, orally disintegrating; Tablet
    Routeorally disintegrating; oral
    Strength5mg; 2mg; 30mg; 10mg; 15mg; 20mg
    Market StatusTentative Approval
    CompanyApotex; Alembic Pharms; Torrent Pharms; Zydus Pharms Usa; Barr Labs; Sun Pharma Global

    4.2 Therapeutic Uses

    Antipsychotic Agents

    National Library of Medicine's Medical Subject Headings. Aripiprazole. Online file (MeSH, 2014). Available from, as of December 18, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Aripiprazole is used IM for the acute management of agitation associated with schizophrenia or bipolar disorder, mixed or manic, in adults for whom treatment with aripiprazole is appropriate and who require an IM antipsychotic agent for rapid control of behaviors that interfere with diagnosis and care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior).

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2428

    Aripiprazole is used orally for the acute treatment of irritability associated with autistic disorder.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2428

    Aripiprazole is used orally as an adjunct to antidepressants for the acute treatment of major depressive disorder in adults.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2428

    For more Therapeutic Uses (Complete) data for ARIPIPRAZOLE (6 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis. /Included in label/

    NIH; DailyMed. Current Medication Information for ABILIFY- aripiprazole tablet; ABILIFY- aripiprazole solution; ABILIFY DISCMELT- aripiprazole tablet, orally disintegrating; ABILIFY- aripiprazole injection, solution (Updated: July 2014). Available from, as of March 31, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac

    /BOXED WARNING/ WARNING: INCREASED SUICIDALTHOUGHTS AND BEHAVIORS. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression. /Included in label/

    NIH; DailyMed. Current Medication Information for ABILIFY- aripiprazole tablet; ABILIFY- aripiprazole solution; ABILIFY DISCMELT- aripiprazole tablet, orally disintegrating; ABILIFY- aripiprazole injection, solution (Updated: July 2014). Available from, as of March 31, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac

    Contraindications: Known hypersensitivity reaction to aripiprazole or any ingredient in the formulation; such reactions have ranged from pruritus/urticaria to anaphylaxis.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2429

    Safety and effectiveness in pediatric patients with bipolar mania were established in a 4-week, placebo-controlled clinical trial in 197 pediatric patients aged 10 to 17 years. The incidence of discontinuation due to adverse reactions between aripiprazole-treated and placebo-treated pediatric patients (10 to 17 years) was 7% and 2%, respectively. Commonly observed adverse reactions associated with the use of aripiprazole in pediatric patients with bipolar mania (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness. Although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients.

    NIH; DailyMed. Current Medication Information for ABILIFY- aripiprazole tablet; ABILIFY- aripiprazole solution; ABILIFY DISCMELT- aripiprazole tablet, orally disintegrating; ABILIFY- aripiprazole injection, solution (Updated: July 2014). Available from, as of September 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac

    For more Drug Warnings (Complete) data for ARIPIPRAZOLE (27 total), please visit the HSDB record page.

    4.4 Drug Indication

    Aripiprazole is indicated for manic and mixed episodes associated with bipolar I disorder, irritability associated with autism spectrum disorder, treatment of schizophrenia, treatment of Tourette's disorder, and as an adjunctive treatment of major depressive disorder. An injectable formulation of aripiprazole is indicated for agitation associated with schizophrenia or bipolar mania.

    FDA Label

    Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

    Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

    Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

    Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

    Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

    Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

    Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

    Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

    Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

    Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

    Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

    Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

    Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

    Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

    Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

    Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

    Treatment of bipolar affective disorder, Treatment of schizophrenia

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Aripiprazole has high affinity for serotonin type 2 (5HT2), dopamine type 2 (D2), alpha1 and 2 adrenergic, and H1 histaminergic receptors. It also acts on a number of other receptors with lower affinity. The exact method by which aripiprazole's action on these receptors translates to a clinically relevant effect is not yet known.

    5.2 MeSH Pharmacological Classification

    Antidepressive Agents

    Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)

    Dopamine Agonists

    Drugs that bind to and activate dopamine receptors. (See all compounds classified as Dopamine Agonists.)

    Dopamine D2 Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of DOPAMINE D2 RECEPTORS. (See all compounds classified as Dopamine D2 Receptor Antagonists.)

    Serotonin 5-HT1 Receptor Agonists

    Endogenous compounds and drugs that specifically stimulate SEROTONIN 5-HT1 RECEPTORS. Included under this heading are agonists for one or more of the specific 5-HT1 receptor subtypes. (See all compounds classified as Serotonin 5-HT1 Receptor Agonists.)

    Serotonin 5-HT2 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes. (See all compounds classified as Serotonin 5-HT2 Receptor Antagonists.)

    Antipsychotic Agents

    Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ARIPIPRAZOLE
    5.3.2 FDA UNII
    82VFR53I78
    5.3.3 Pharmacological Classes
    Atypical Antipsychotic [EPC]
    5.4 ATC Code

    N05AX12

    N05AX12

    N05AX12

    N05AX12

    N05AX12

    N05AX12

    N05AX12

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    N - Nervous system

    N05 - Psycholeptics

    N05A - Antipsychotics

    N05AX - Other antipsychotics

    N05AX12 - Aripiprazole

    5.5 Absorption, Distribution and Excretion

    Absorption

    Aripiprazole tablets are 87% bioavailable and reach peak plasma concentrations in 3 to 5 hours. These tablets can be taken with or without food, but a high fat meal can delay the time to max concentration by 3 hours and up to 12 hours for the active metabolite.

    Route of Elimination

    25% of a given dose will be eliminated in urine and 55% in the feces. <1% of a dose is eliminated in the urine as unmetabolized aripiprazole and approximately 18% of a dose will be eliminated in the feces unmetabolized.

    Volume of Distribution

    404L or 4.9L/kg.

    Clearance

    0.8mL/min/kg. Other studies have reported a clearance rate of 32971042mL/hr.

    Oral availability 87%. Aripiprazole is well absorbed and can be administered with or without food. Administration with a high fat meal did not affect the Cmax or AUC, but delayed Tmax by 3 hours for aripiprazole, and 12 hours for dehydro-aripiprazole.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2431

    Time to peak concentration: Peak plasma concentrations: within 3 to 5 hours.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2431

    The steady-state volume of distribution of aripiprazole following intravenous administration is high (404 L or 4.9 L/kg), indicating extensive extravascular distribution. At therapeutic concentrations, aripiprazole and its major metabolite are greater than 99% bound to serum proteins, primarily to albumin.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2431

    There was dose-dependent D2-receptor occupancy indicating brain penetration of aripiprazole in healthy human volunteers administered 0.5 to 30 mg per day.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2431

    For more Absorption, Distribution and Excretion (Complete) data for ARIPIPRAZOLE (8 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Metabolism of aripiprazole is predominantly hepatic, mediated mostly by cytochrome P450 (CYP)3A4 and CYP2D6. These enzymes perform dehydrogenation and hydroxylation while CYP3A4 alone performs N-dealkylation. At any given time, the active metabolite dehydro-aripiprazole is approximately 40% of the drug available in plasma.

    Aripiprazole is extensively metabolized in the liver principally via dehydrogenation, hydroxylations, and N-dealkylation by the cytochrome P-450 (CYP) 2D6 and 3A4 isoenzymes. The major active metabolite of aripiprazole, dehydro-aripiprazole, exhibits affinity for D2 receptors similar to that of the parent compound and represents approximately 40% of the aripiprazole area under the concentration-time curve (AUC) in plasma. Steady-state plasma concentrations of both aripiprazole and dehydro-aripiprazole are achieved within 14 days.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2433

    ABILIFY activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its major metabolite, dehydro-aripiprazole, which has been shown to have affinities for D2 receptors similar to the parent drug and represents 40% of the parent drug exposure in plasma.

    NIH; DailyMed. Current Medication Information for ABILIFY- aripiprazole tablet; ABILIFY- aripiprazole solution; ABILIFY DISCMELT- aripiprazole tablet, orally disintegrating; ABILIFY- aripiprazole injection, solution (Updated: July 2014). Available from, as of September 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac

    Aripiprazole has known human metabolites that include 2,3-dichlorophenylpiperazine, 4-Hydroxyaripiprazole, 4-[(2-oxo-3,4-dihydro-1H-quinolin-7-yl)oxy]butanal, and dehydro-aripiprazole.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    The half life of aripiprazole is 75 hours while the half life of the active metabolite is 94 hours. For populations that are poor CYP2D6 metabolizers, the half life of aripiprazole is 146 hours and these patients should be treated with half the normal dose. Other studies have reported a half life of 61.0319.59 hours for aripiprazole and 279299 hours for the active metabolite.

    The mean elimination half-lives are about 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively.

    NIH; DailyMed. Current Medication Information for ABILIFY- aripiprazole tablet; ABILIFY- aripiprazole solution; ABILIFY DISCMELT- aripiprazole tablet, orally disintegrating; ABILIFY- aripiprazole injection, solution (Updated: July 2014). Available from, as of September 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac

    5.8 Mechanism of Action

    The antipsychotic action of aripiprazole is likely due to the agonism of D2 and 5-HT1A receptors though the exact mechanism has not been defined. Some adverse effects may be due to action on other receptors. For example, orthostatic hypotension may be explained by antagonism of the adrenergic alpha1 receptors.

    The exact mechanism of antipsychotic action of aripiprazole has not been fully elucidated but, like that of other atypical antipsychotic agents (e.g.,olanzipine, risperidone, ziprasidon), may involve the drug's activity at dopamine D2 and serotonin type (5-HT1A) and type 2 (5-HT2A) receptors. However, aripiprazole appears to differ from other atypical antipsychotic agents because the drug demonstrates partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Antagonism at other receptors (e.g., alpha1-adrenergic receptors, histamine H1 receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, somnolence) observed with aripiprazole.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2432

    ...Aripiprazole exhibits typical antagonism at dopamine (D2) receptors in the mesolimbic pathway, as well as having unique partial agonist activity at D2 receptors in the mesocortical pathway. As exemplified by other atypical antipsychotics, it displays strong 5-HT(2a) receptor antagonism and is similar to ziprasidone in also having agonistic activity at the 5-HT(1a) receptor. Among the atypical antipsychotics, aripiprazole displays the lowest affinity for alpha(1)adrenergic (alpha(1)), histamine (H1) and muscarinic (M1) receptors. This combination of effects may be responsible for its efficacy in positive and negative symptoms of schizophrenia and in bipolar disorder. ...Other early data suggest that aripiprazole may induce reductions in plasma prolactin, as well as in plasma glucose and lipid profiles ...

    PMID:12472374 Goodnick PJ, Jerry JM; Expert Opin Pharmacother 3 (12): 1773-81 (2002)

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AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649010600,"product":"ARIPIPRAZOLE","address":"781, INDUSTRIAL AREA,,PHASE-II,","city":"CHANDIGARH,CHANDIGARH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"IND SWIFT LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"850","totalValueFC":"43317.4","currency":"USD","unitRateINR":"65365","date":"04-Apr-2022","totalValueINR":"3268250","totalValueInUsd":"43317.4","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"8134298","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707849000,"product":"ARIPIPRAZOLE - B.NO.5735-23-004M1\/005M1\/006M1 - QTY 1 KG - AS PER INVOICE","address":"SURVEY NO. 144\/146,,","city":"TAL: SAVLI","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"INNOXEL LIFESCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1180","totalValueFC":"1193.9","currency":"USD","unitRateINR":"99061","date":"14-Feb-2024","totalValueINR":"99061","totalValueInUsd":"1193.9","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"2137658","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI ZHEJIANG 317024, CHINASDNF CHINA","customerAddress":"SURVEY NO. 144\/146,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710700200,"product":"ARIPIPRAZOLE MONOHYDRATE , BATCH NO:A21528E","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1.2","unit":"KGS","unitRateFc":"15000","totalValueFC":"19921.5","currency":"EUR","unitRateINR":"1378500","date":"18-Mar-2024","totalValueINR":"1654200","totalValueInUsd":"19921.5","indian_port":"Ahmedabad Air","hs_no":"29337990","bill_no":"2631171","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"JOAN BUSCALLA 0 08173 SANT CUGAT DEL VALLES BARCELONA SPAINSDNF SPAIN","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"ARIPIPRAZOLE MONOHYDRATE STERILE LOT NO-2102001","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"24000","totalValueFC":"26615.3","currency":"EUR","unitRateINR":"2224800","date":"22-Jul-2024","totalValueINR":"2224800","totalValueInUsd":"26615.3","indian_port":"Ahmedabad Air","hs_no":"29337990","bill_no":"4633076","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Sterile","supplierPort":"BARCELONA","supplierAddress":"JOAN BUSCALLA 10 08173 SANT CUGAT DEL VALLES BARCELONA SPAINSDNF SPAIN","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740421800,"product":"(FOC) ARIPIPRAZOLE API (FOC) ARIPIPRAZOLE API","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"ACTAVIS LTD","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"WATSON PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.051","unit":"KGS","unitRateFc":"247.5","totalValueFC":"12.7","currency":"EUR","unitRateINR":"21717.6","date":"25-Feb-2025","totalValueINR":"1107.6","totalValueInUsd":"12.7","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"8558301","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"Bulebel Industrial Estate Zejtun ZT N 300 Malta Zejtun , , Malta SDNF Malta","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"}]
    05-Jan-2022
    30-Apr-2025
    KGS
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    Average Price (USD/KGS)

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    API Imports and Exports

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    INTERMEDIATE SUPPLIERS

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    01

    Tagoor Laboratories

    India
    CPhI WW Frankfurt
    Booth #12.1B84
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    Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

    1-(2,3-Dichlorophenyl)Piperazine Hydrochloride (DC...

    CAS Number : 119532-26-2

    End Use API : Aripiprazole

    About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

    Tagoor Laboratories

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    02

    Allchem Laboratories

    India
    PharmaVenue
    Not Confirmed
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    Allchem Laboratories

    India
    PharmaVenue
    Not Confirmed
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    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    7-Hydroxy-3,4-dihydro-1H-quinolin-2-one

    CAS Number : 22246-18-0

    End Use API : Aripiprazole

    About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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    03

    Allchem Laboratories

    India
    PharmaVenue
    Not Confirmed
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    Allchem Laboratories

    India
    PharmaVenue
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    1-(2,3-Dichloro Phenyl) Piperazine HCl

    CAS Number : 119532-26-2

    End Use API : Aripiprazole

    About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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    04

    Allchem Laboratories

    India
    PharmaVenue
    Not Confirmed
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    Allchem Laboratories

    India
    PharmaVenue
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    7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone

    CAS Number : 129722-34-5

    End Use API : Aripiprazole

    About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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    05

    Ami Organics Private Limited

    India
    PharmaVenue
    Not Confirmed
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    Ami Organics Private Limited

    India
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    1-(2,3-DICHLOROPHENYL)PIPERAZINE HCL

    CAS Number : 119532-26-2

    End Use API : Aripiprazole

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    06

    Anugraha Chemicals

    India
    PharmaVenue
    Not Confirmed
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    Anugraha Chemicals

    India
    PharmaVenue
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    7-hydroxy-3,4-dihydroquinolin-2(1H)-one

    CAS Number : 22246-18-0

    End Use API : Aripiprazole

    About The Company : Anugraha Chemicals, a company engaged in Contract Manufacturing and Manufacturing of APIs, Intermediates and Fine Chemicals, was established in 1991 and has a r...

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    07

    Aragen Life Sciences

    India
    PharmaVenue
    Not Confirmed
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    Aragen Life Sciences

    India
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    7-(4-Bromobutoxy)-3,4-Dihydroquinoline-2 (BBQ)

    CAS Number : 129722-34-5

    End Use API : Aripiprazole

    About The Company : Aragen is a trusted R&D and manufacturing partner to the global life sciences industry. From concept to commercial, we transform your ideas into solutions for b...

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    08

    Believe Pharma

    India
    PharmaVenue
    Not Confirmed
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    Believe Pharma

    India
    PharmaVenue
    Not Confirmed
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    7–(4–chlorobutoxy)–3,4–dihydroquinolin–2...

    CAS Number : 120004-79-7

    End Use API : Aripiprazole

    About The Company : Believe pharma is one of the leading manufacturers of APIs and its intermediates with multi-dimensional business activities. The company maintain a high standa...

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    09

    Believe Pharma

    India
    PharmaVenue
    Not Confirmed
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    Believe Pharma

    India
    PharmaVenue
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    1–(2,3–dichlorophenyl) piperazine hydrochlorid...

    CAS Number : 119532-26-2

    End Use API : Aripiprazole

    About The Company : Believe pharma is one of the leading manufacturers of APIs and its intermediates with multi-dimensional business activities. The company maintain a high standa...

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    10

    Believe Pharma

    India
    PharmaVenue
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    Believe Pharma

    India
    PharmaVenue
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    7-Hydroxy-3,4-dihydro-2(1H)-Quinolinone

    CAS Number : 22246-18-0

    End Use API : Aripiprazole

    About The Company : Believe pharma is one of the leading manufacturers of APIs and its intermediates with multi-dimensional business activities. The company maintain a high standa...

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    FDF Dossiers

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    01

    Orion Corporation

    Finland
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    Flag Finland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Sweden

    aripiprazole (anhydrous)

    Brand Name : Aripiprazole Orion

    Dosage Form : TABLET

    Dosage Strength : 5 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

    Fermion Orion Company Banner

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    Orion Corporation

    Finland
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    Pharmacy Expo
    Not Confirmed
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    Regulatory Info :

    Registration Country : Sweden

    aripiprazole (anhydrous)

    Brand Name : Aripiprazole Orion

    Dosage Form : TABLET

    Dosage Strength : 10 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

    Fermion Orion Company Banner

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    Orion Corporation

    Finland
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    Regulatory Info :

    Registration Country : Sweden

    aripiprazole (anhydrous)

    Brand Name : Aripiprazole Orion

    Dosage Form : TABLET

    Dosage Strength : 15MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

    Fermion Orion Company Banner

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    Orion Corporation

    Finland
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    Regulatory Info :

    Registration Country : Sweden

    aripiprazole (anhydrous)

    Brand Name : Aripiprazole Orion

    Dosage Form : TABLET

    Dosage Strength : 30 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

    Fermion Orion Company Banner

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    05

    Cohance Lifesciences

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Regulatory Info :

    Registration Country : India

    Aripiprazole

    Brand Name :

    Dosage Form : Oral Dispersible Tablet

    Dosage Strength : 2MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

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    Cohance Lifesciences

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Regulatory Info :

    Registration Country : India

    Aripiprazole

    Brand Name :

    Dosage Form : Oral Dispersible Tablet

    Dosage Strength : 5MG

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    Registration Country : India

    Cohance

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    Cohance Lifesciences

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Registration Country : India

    Aripiprazole

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    Dosage Form : Oral Dispersible Tablet

    Dosage Strength : 10MG

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    Registration Country : India

    Cohance

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    Cohance Lifesciences

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Registration Country : India

    Aripiprazole

    Brand Name :

    Dosage Form : Oral Dispersible Tablet

    Dosage Strength : 15MG

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    Cohance

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    Cohance Lifesciences

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Aripiprazole

    Brand Name :

    Dosage Form : Oral Dispersible Tablet

    Dosage Strength : 20MG

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    Registration Country : India

    Cohance

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    Cohance Lifesciences

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Aripiprazole

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    Dosage Form : Oral Dispersible Tablet

    Dosage Strength : 30MG

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    Cohance

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    DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;INT...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 300MG/VIAL

    USFDA APPLICATION NUMBER - 202971

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    ABOUT THIS PAGE

    Looking for 129722-12-9 / Aripiprazole API manufacturers, exporters & distributors?

    Aripiprazole manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Aripiprazole

    Synonyms

    129722-12-9, Abilify, Abilitat, Opc-14597, Abilify discmelt, Opc 14597

    Cas Number

    129722-12-9

    Unique Ingredient Identifier (UNII)

    82VFR53I78

    About Aripiprazole

    A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression.

    CAS-129722-12-9 Manufacturers

    A CAS-129722-12-9 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-129722-12-9, including repackagers and relabelers. The FDA regulates CAS-129722-12-9 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-129722-12-9 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 CAS-129722-12-9 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    CAS-129722-12-9 Suppliers

    A CAS-129722-12-9 supplier is an individual or a company that provides CAS-129722-12-9 active pharmaceutical ingredient (API) or CAS-129722-12-9 finished formulations upon request. The CAS-129722-12-9 suppliers may include CAS-129722-12-9 API manufacturers, exporters, distributors and traders.

    click here to find a list of CAS-129722-12-9 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    CAS-129722-12-9 USDMF

    A CAS-129722-12-9 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-129722-12-9 active pharmaceutical ingredient (API) in detail. Different forms of CAS-129722-12-9 DMFs exist exist since differing nations have different regulations, such as CAS-129722-12-9 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A CAS-129722-12-9 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-129722-12-9 USDMF includes data on CAS-129722-12-9's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-129722-12-9 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of CAS-129722-12-9 suppliers with USDMF on PharmaCompass.

    CAS-129722-12-9 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 CAS-129722-12-9 Drug Master File in Japan (CAS-129722-12-9 JDMF) empowers CAS-129722-12-9 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 CAS-129722-12-9 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-129722-12-9 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 CAS-129722-12-9 suppliers with JDMF on PharmaCompass.

    CAS-129722-12-9 KDMF

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

    Pharmaceutical companies submit a CAS-129722-12-9 Drug Master File in Korea (CAS-129722-12-9 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CAS-129722-12-9. The MFDS reviews the CAS-129722-12-9 KDMF as part of the drug registration process and uses the information provided in the CAS-129722-12-9 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a CAS-129722-12-9 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 CAS-129722-12-9 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of CAS-129722-12-9 suppliers with KDMF on PharmaCompass.

    CAS-129722-12-9 CEP

    A CAS-129722-12-9 CEP of the European Pharmacopoeia monograph is often referred to as a CAS-129722-12-9 Certificate of Suitability (COS). The purpose of a CAS-129722-12-9 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CAS-129722-12-9 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CAS-129722-12-9 to their clients by showing that a CAS-129722-12-9 CEP has been issued for it. The manufacturer submits a CAS-129722-12-9 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CAS-129722-12-9 CEP holder for the record. Additionally, the data presented in the CAS-129722-12-9 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CAS-129722-12-9 DMF.

    A CAS-129722-12-9 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CAS-129722-12-9 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 CAS-129722-12-9 suppliers with CEP (COS) on PharmaCompass.

    CAS-129722-12-9 WC

    A CAS-129722-12-9 written confirmation (CAS-129722-12-9 WC) is an official document issued by a regulatory agency to a CAS-129722-12-9 manufacturer, verifying that the manufacturing facility of a CAS-129722-12-9 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CAS-129722-12-9 APIs or CAS-129722-12-9 finished pharmaceutical products to another nation, regulatory agencies frequently require a CAS-129722-12-9 WC (written confirmation) as part of the regulatory process.

    click here to find a list of CAS-129722-12-9 suppliers with Written Confirmation (WC) on PharmaCompass.

    CAS-129722-12-9 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 CAS-129722-12-9 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for CAS-129722-12-9 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 CAS-129722-12-9 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 CAS-129722-12-9 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-129722-12-9 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of CAS-129722-12-9 suppliers with NDC on PharmaCompass.

    CAS-129722-12-9 GMP

    CAS-129722-12-9 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 CAS-129722-12-9 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 CAS-129722-12-9 GMP manufacturer or CAS-129722-12-9 GMP API supplier for your needs.

    CAS-129722-12-9 CoA

    A CAS-129722-12-9 CoA (Certificate of Analysis) is a formal document that attests to CAS-129722-12-9's compliance with CAS-129722-12-9 specifications and serves as a tool for batch-level quality control.

    CAS-129722-12-9 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-129722-12-9 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.

    CAS-129722-12-9 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-129722-12-9 EP), CAS-129722-12-9 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-129722-12-9 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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