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    Chemistry

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    Also known as: 144598-75-4, 9-hydroxyrisperidone, Invega, 9-oh-risperidone, 3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-4-one, Ro76477
    Molecular Formula
    C23H27FN4O3
    Molecular Weight
    426.5  g/mol
    InChI Key
    PMXMIIMHBWHSKN-UHFFFAOYSA-N
    FDA UNII
    838F01T721
    Paliperidone
    A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.
    Paliperidone is an Atypical Antipsychotic.
    1 2D Structure

    Paliperidone

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
    2.1.2 InChI
    InChI=1S/C23H27FN4O3/c1-14-17(23(30)28-9-2-3-19(29)22(28)25-14)8-12-27-10-6-15(7-11-27)21-18-5-4-16(24)13-20(18)31-26-21/h4-5,13,15,19,29H,2-3,6-12H2,1H3
    2.1.3 InChI Key
    PMXMIIMHBWHSKN-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C(=O)N2CCCC(C2=N1)O)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F
    2.2 Other Identifiers
    2.2.1 UNII
    838F01T721
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3-(2-(4-(6-fluoro-3-(1,2-benzisoxazolyl))-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido(1,2-a)pyrimidin-4-one

    2. 9 Hydroxy Risperidone

    3. 9 Hydroxyrisperidone

    4. 9 Oh Risperidone

    5. 9-hydroxy-risperidone

    6. 9-hydroxyrisperidone

    7. 9-oh-risperidone

    8. Invega

    9. Invega Sustenna

    10. Paliperidone Palmitate

    11. Palmitate, Paliperidone

    12. R 76477

    13. R-76477

    14. R76477

    15. Sustenna, Invega

    2.3.2 Depositor-Supplied Synonyms

    1. 144598-75-4

    2. 9-hydroxyrisperidone

    3. Invega

    4. 9-oh-risperidone

    5. 3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-4-one

    6. Ro76477

    7. C23h27fn4o3

    8. R-76477

    9. 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one

    10. Ro-76477

    11. 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido[1,2-a]pyrimidin-4-one

    12. Chembl1621

    13. 4h-pyrido(1,2-a)pyrimidin-4-one, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-

    14. Chebi:83804

    15. 144598-75-4 (free Base)

    16. Nsc-759623

    17. (9rs)-3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl))ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4h-pyrido(1,2-a)pyrimidin-4-one

    18. 4h-pyrido[1,2-a]pyrimidin-4-one, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-

    19. 838f01t721

    20. Paliperidone [inn]

    21. 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-4h,6h,7h,8h,9h-pyrido[1,2-a]pyrimidin-4-one

    22. Palliperidone

    23. 9-hydroxy Risperidone

    24. R 76477

    25. Hsdb 8148

    26. Rac 9-hydroxy Risperidone

    27. Unii-838f01t721

    28. 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido(1,2-a)pyrimidin-4-one

    29. 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one

    30. Paliperidone [usan:inn:ban:jan]

    31. Invega (tn)

    32. Mfcd00871802

    33. Paliperidone- Bio-x

    34. Risperidone-m 9-hydroxy

    35. Paliperidone [mi]

    36. Paliperidone [jan]

    37. Paliperidone [usan]

    38. Paliperidone [vandf]

    39. Paliperidone [mart.]

    40. Jns-007er

    41. Mls004773953

    42. Paliperidone [usp-rs]

    43. Paliperidone [who-dd]

    44. Schembl436689

    45. Paliperidone (jan/usp/inn)

    46. Gtpl7258

    47. Paliperidone [ema Epar]

    48. Dtxsid7049059

    49. 9-hydroxyrisperidone-d4 Solution

    50. Paliperidone, >=98% (hplc)

    51. Bcpp000132

    52. Hms3261b06

    53. Hms3743m09

    54. Hms3887k15

    55. Paliperidone [orange Book]

    56. Amy24885

    57. Bcp02338

    58. Hy-a0019

    59. Paliperidone [usp Monograph]

    60. Tox21_500562

    61. Bdbm50252513

    62. S1724

    63. Akos005266713

    64. Akos016339656

    65. Akos025392164

    66. Ac-1282

    67. Bcp9001047

    68. Ccg-221866

    69. Cs-0386

    70. Db01267

    71. Ks-1279

    72. Lp00562

    73. Nsc 759623

    74. Pb27526

    75. Sdccgsbi-0633730.p001

    76. Ncgc00186014-01

    77. Ncgc00186014-12

    78. Ncgc00261247-01

    79. 4h-pyrido(1,2-a)pyrimidin-4-one, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8-tetrahydro-9-hydroxy-2-methyl-

    80. 4h-pyrido(2,1-a)pyrimidin-4-one, 6,7,8,9-tetrahydro-3-(2-(4-(6-fluro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-

    81. As-13860

    82. Bp164223

    83. Smr001456280

    84. Risperidone Impurity, 9-hydroxyrisperidone-

    85. 9-hydroxy Risperidone-d4 (paliperidone D4)

    86. 9-hydroxyrisperidone 1.0 Mg/ml In Methanol

    87. Ft-0600425

    88. Ft-0670101

    89. Ft-0670102

    90. P1897

    91. Risperidone Impurity C [ep Impurity]

    92. C21516

    93. D05339

    94. 598p754

    95. L023985

    96. Q423292

    97. Sr-02000000862

    98. Q-101425

    99. Sr-02000000862-3

    100. Brd-a99888680-001-04-6

    101. Paliperidone, United States Pharmacopeia (usp) Reference Standard

    102. Risperidone Impurity, 9-hydroxyrisperidone- [usp Impurity]

    103. (+/-)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido[1,2-a]pyrimidin-4-one

    104. (9rs)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-4-one (9-hydroxyrisperidone)

    105. 3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one

    106. 3-[ 2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido[1,2-a]pyrimidin-4-one

    107. 3-[ 2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido[1,2-a]pyrimidin4-one

    108. 3-[2-[4-(6-fluoro-1,2-benzisoxazol- 3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hy Droxy-2-methyl-4h-pyrido[1,2-a]pyrimidin-4-one

    109. 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido[1,2-a]-pyrimidin-4-one

    110. 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyrido[1,2-a]pyrimidin-4-one, 9-hydroxyrisperidone

    111. 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-9-hydroxy-6,7,8,9-tetrahydro-2-methyl-4h-pyrido[1,2-a]-pyrimidin-4-one

    112. 3-{2-[4-(6-fluoro-1,2-benzoisoxazol-3-yl)-1-piperidinyl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-alpha]pyrimidin-4-one

    113. 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-4-one

    114. 3-{2-[4-(6-fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-9-hydroxy-2-methyl-6,7,8,9- Tetrahydro-pyrido[1,2-a]pyrimidin-4-one

    115. 6,7,8,9-tetrahydro-3-(2-(4-(6-fluro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-4h-pyrido[2,1-a]pyrimidin-4-one

    116. 9-hydroxyrisperidone Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 426.5 g/mol
    Molecular Formula C23H27FN4O3
    XLogP32.2
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count4
    Exact Mass426.20671890 g/mol
    Monoisotopic Mass426.20671890 g/mol
    Topological Polar Surface Area82.2 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity764
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    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 NameInvega
    PubMed HealthPaliperidone
    Drug ClassesAntipsychotic
    Drug LabelPaliperidone, the active ingredient in INVEGA Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (...
    Active IngredientPaliperidone
    Dosage FormTablet, extended release
    Routeoral; Oral
    Strength9mg; 1.5mg; 12mg; 6mg; 3mg
    Market StatusPrescription
    CompanyJanssen Pharms; Janssen

    2 of 4  
    Drug NameInvega sustenna
    PubMed HealthPaliperidone (Injection)
    Drug ClassesAntipsychotic
    Active IngredientPaliperidone palmitate
    Dosage FormSuspension, extended release
    RouteIntramuscular
    Strength234mg/1.5ml (156mg/ml); 156mg/ml (156mg/ml); 117mg/0.75ml (117mg/0.75ml); 39mg/0.25ml (39mg/0.25ml); 78mg/0.5ml (78mg/0.5ml)
    Market StatusPrescription
    CompanyJanssen Pharms

    3 of 4  
    Drug NameInvega
    PubMed HealthPaliperidone
    Drug ClassesAntipsychotic
    Drug LabelPaliperidone, the active ingredient in INVEGA Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (...
    Active IngredientPaliperidone
    Dosage FormTablet, extended release
    Routeoral; Oral
    Strength9mg; 1.5mg; 12mg; 6mg; 3mg
    Market StatusPrescription
    CompanyJanssen Pharms; Janssen

    4 of 4  
    Drug NameInvega sustenna
    PubMed HealthPaliperidone (Injection)
    Drug ClassesAntipsychotic
    Active IngredientPaliperidone palmitate
    Dosage FormSuspension, extended release
    RouteIntramuscular
    Strength234mg/1.5ml (156mg/ml); 156mg/ml (156mg/ml); 117mg/0.75ml (117mg/0.75ml); 39mg/0.25ml (39mg/0.25ml); 78mg/0.5ml (78mg/0.5ml)
    Market StatusPrescription
    CompanyJanssen Pharms

    4.2 Therapeutic Uses

    Antipsychotic Agent

    National Library of Medicine's Medical Subject Headings. Paliperidone. Online file (MeSH, 2014). Available from, as of November 19, 2013: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Invega (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia. The efficacy of Invega in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    Invega (paliperidone) Extended-Release Tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therap. The efficacy of Invega in schizoaffective disorder was established in two 6-week trials in adults. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    Invega Sustenna (paliperidone palmitate) is indicated for the treatment of schizophrenia. Efficacy was established in four short-term studies and one longer-term study in adults. /Paliperidone palmitate; Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for IINVEGA SUSTENNA (paliperidone palmitate) injection (October 2012). Available from, as of November 15, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1af14e42-951d-414d-8564-5d5fce138554

    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 17 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 (e.g., heart failure, sudden death) or infectious (e.g., 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. Invega (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    /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. Invega Sustenna is not approved for use in patients with dementia-related psychosis. /Paliperidone palmitate/

    US Natl Inst Health; DailyMed. Current Medication Information for IINVEGA SUSTENNA (paliperidone palmitate) injection (October 2012). Available from, as of November 15, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1af14e42-951d-414d-8564-5d5fce138554

    Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients receiving risperidone or paliperidone. Paliperidone is therefore contraindicated in patients with a known hypersensitivity to paliperidone, risperidone, or any ingredient in the paliperidone formulation.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2504

    An increased incidence of adverse cerebrovascular events (cerebrovascular accidents and transient ischemic attacks), including fatalities, has been observed in geriatric patients with dementia-related psychosis treated with certain atypical antipsychotic agents (aripiprazole, olanzapine, risperidone) in placebo-controlled studies. The manufacturer states that paliperidone is not approved for the treatment of patients with dementia-related psychosis.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2504

    For more Drug Warnings (Complete) data for Paliperidone (32 total), please visit the HSDB record page.

    4.4 Drug Indication

    As an oral extended-release tablet and a once-monthly extended-release suspension for intramuscular injection, paliperidone is indicated for the treatment of adults and adolescents with schizophrenia and in the treatment of schizoaffective disorder in combination with antidepressants or mood stabilizers. Paliperidone is also available in both an every-three-month and twice-yearly extended-release suspension for intramuscular injection for the treatment of schizophrenia.

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

    Invega is indicated for the treatment of schizoaffective disorder in adults.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Paliperidone is an atypical antipsychotic developed by Janssen Pharmaceutica. Chemically, paliperidone is primary active metabolite of the older antipsychotic risperidone (paliperidone is 9-hydroxyrisperidone). The mechanism of action is unknown but it is likely to act via a similar pathway to risperidone.

    5.2 MeSH Pharmacological Classification

    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.)

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    PALIPERIDONE
    5.3.2 FDA UNII
    838F01T721
    5.3.3 Pharmacological Classes
    Atypical Antipsychotic [EPC]
    5.4 ATC Code

    N05AX13

    N - Nervous system

    N05 - Psycholeptics

    N05A - Antipsychotics

    N05AX - Other antipsychotics

    N05AX13 - Paliperidone

    5.5 Absorption, Distribution and Excretion

    Absorption

    The absolute oral bioavailability of paliperidone following paliperidone administration is 28%.

    Route of Elimination

    One week following administration of a single oral dose of 1 mg immediate-release 14C-paliperidone to 5 healthy volunteers, 59% (range 51% 67%) of the dose was excreted unchanged into urine, 32% (26% 41%) of the dose was recovered as metabolites, and 6% 12% of the dose was not recovered.

    Volume of Distribution

    487 L

    The absolute oral bioavailability of paliperidone following Invega administration is 28%. Administration of a 12 mg paliperidone extended-release tablet to healthy ambulatory subjects with a standard high-fat/high-caloric meal gave mean Cmax and AUC values of paliperidone that were increased by 60% and 54%, respectively, compared with administration under fasting conditions. Clinical trials establishing the safety and efficacy of Invega were carried out in subjects without regard to the timing of meals. While Invega can be taken without regard to food, the presence of food at the time of Invega administration may increase exposure to paliperidone. Based on a population analysis, the apparent volume of distribution of paliperidone is 487 L. The plasma protein binding of racemic paliperidone is 74%.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    Following a single dose, the plasma concentrations of paliperidone gradually rise to reach peak plasma concentration (Cmax) approximately 24 hours after dosing. The pharmacokinetics of paliperidone following Invega administration are dose-proportional within the available dose range. The terminal elimination half-life of paliperidone is approximately 23 hours. Steady-state concentrations of paliperidone are attained within 4-5 days of dosing with Invega in most subjects. The mean steady-state peak:trough ratio for an Invega dose of 9 mg was 1.7 with a range of 1.2-3.1.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    One week following administration of a single oral dose of 1 mg immediate-release (14)C-paliperidone to 5 healthy volunteers, 59% (range 51% - 67%) of the dose was excreted unchanged into urine, 32% (26% - 41%) of the dose was recovered as metabolites, and 6% - 12% of the dose was not recovered. Approximately 80% of the administered radioactivity was recovered in urine and 11% in the feces.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    Paliperidone is excreted in human breast milk.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    For more Absorption, Distribution and Excretion (Complete) data for Paliperidone (7 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, in vivo results indicate that these isozymes play a limited role in the overall elimination of paliperidone. Four primary metabolic pathways have been identified in vivo, none of which could be shown to account for more than 10% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission. Paliperidone does not undergo extensive metabolism and a significant portion of its metabolism occurs in the kidneys.

    Four primary metabolic pathways have been identified in vivo, none of which could be shown to account for more than 10% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, in vivo results indicate that these isozymes play a limited role in the overall elimination of paliperidone.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    Paliperidone is a known human metabolite of risperidone.

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

    5.7 Biological Half-Life

    The terminal elimination half-life of paliperidone is approximately 23 hours.

    The median apparent half-life of paliperidone following Invega Sustenna single-dose administration over the dose range of 39 mg - 234 mg ranged from 25 days - 49 days. /Paliperidone palmitate/

    US Natl Inst Health; DailyMed. Current Medication Information for IINVEGA SUSTENNA (paliperidone palmitate) injection (October 2012). Available from, as of November 15, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1af14e42-951d-414d-8564-5d5fce138554

    The terminal elimination half-life of paliperidone is approximately 23 hours.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    5.8 Mechanism of Action

    Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone, as with other drugs having efficacy in schizophrenia, is unknown, but it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.

    The exact mechanism of paliperidone's antipsychotic action, like that of other antipsychotic agents, has not been fully elucidated, but may involve antagonism of central dopamine type 2 (D2) and serotonin type 2 (5-hydroxytryptamine [5-HT2A]) receptors.1 39 41 Antagonism at a1- and a2-adrenergic and histamine (H1) receptors may contribute to other therapeutic and adverse effects observed with the drug.1 2 39 Paliperidone possesses no affinity for cholinergic muscarinic and beta1- and beta2-adrenergic receptors.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2506

    Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone, as with other drugs having efficacy in schizophrenia, is unknown, but it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.

    US Natl Inst Health; DailyMed. Current Medication Information for INVEGA (paliperidone) tablet, extended release (June 2011). Available from, as of November 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916

    Paliperidone is an active metabolite of the second-generation atypical antipsychotic, risperidone recently approved for the treatment of schizophrenia and schizoaffective disorder. Because paliperidone differs from risperidone by only a single hydroxyl group, questions have been raised as to whether there are significant differences in the effects elicited between these two drugs. /The researchers/ compared the relative efficacies of paliperidone versus risperidone to regulate several cellular signalling pathways coupled to four selected GPCR targets that are important for either therapeutic or adverse effects: human dopamine D2 , human serotonin 2A receptor subtype (5-HT2A ), human serotonin 2C receptor subtype and human histamine H1 receptors. Whereas the relative efficacies of paliperidone and risperidone were the same for some responses, significant differences were found for several receptor-signalling systems, with paliperidone having greater or less relative efficacy than risperidone depending upon the receptor-response pair. Interestingly, for 5-HT2A -mediated recruitment of beta-arrestin, 5-HT2A -mediated sensitization of ERK, and dopamine D2 -mediated sensitization of adenylyl cyclase signalling, both paliperidone and risperidone behaved as agonists. These results suggest that the single hydroxyl group of paliperidone promotes receptor conformations that can differ from those of risperidone leading to differences in the spectrum of regulation of cellular signal transduction cascades. Such differences in signalling at the cellular level could lead to differences between paliperidone and risperidone in therapeutic efficacy or in the generation of adverse effects.

    PMID:23826915 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3791992 Clarke WP et al; Br J Pharmacol 170 (3): 532-45 (2013)

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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"38350000","totalValueFC":"794.7","currency":"USD","unitRateINR":"3071111500","date":"09-May-2022","totalValueINR":"61422.23","totalValueInUsd":"794.7","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"8602325","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678300200,"product":"(N.C.V) PALIPERIDONE PALMITATE POWDER (1BOTTLE=41.3G) (FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.04","actualQuantity":"41.3","unit":"GMS","unitRateFc":"40","totalValueFC":"1798.6","currency":"EUR","unitRateINR":"3582","date":"09-Mar-2023","totalValueINR":"147936.6","totalValueInUsd":"1798.6","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"4962880","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"PALIPERIDONE PALMITATE IH STERILE:35024322418BATCH FG23202010\/FG23202011\/FG23202012\/ FG23202013\/FG23202125(QTY 85.560KGS","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CURIA","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"VIATRIS","customerCountry":"INDIA","quantity":"85.56","actualQuantity":"85.56","unit":"KGS","unitRateFc":"12777.9","totalValueFC":"1217889","currency":"EUR","unitRateINR":"1181958.5","date":"28-Mar-2024","totalValueINR":"101128372.3","totalValueInUsd":"1217889","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"2779420","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Sterile","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"au capital de 6.380.749 Siege social:Zone Industrielle de Laville # 47240 BON-ENCONTRE-FRANCE France","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714156200,"product":"(N.C.V.)(R92670 STERILE GRADE BE2 JNJ-16977831-AAA) PALIPERIDONE PALMITATE POWDER (FOR TESTING PURPOSE ONLY)","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.04","actualQuantity":"40.5","unit":"GMS","unitRateFc":"40","totalValueFC":"1760.5","currency":"EUR","unitRateINR":"3630","date":"27-Apr-2024","totalValueINR":"147015","totalValueInUsd":"1760.5","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3229688","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Sterile","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , BelgiumSDNF Belgium","customerAddress":"30 FORJETT STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721759400,"product":"PALIPERIDONE PALMITATE STERILE , BATCH NO:2304004 ( QTY 0.200 KGS)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"75600","totalValueFC":"15293.5","currency":"USD","unitRateINR":"6391980","date":"24-Jul-2024","totalValueINR":"1278396","totalValueInUsd":"15293.5","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"4669471","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":"2024","qtr":"Q3","strtotime":1725042600,"product":"PALIPERIDONE AMNEAL LOT: 24050174 MFG: 02\/01\/24 EXP: 01\/31\/29 (FOC)PALIPERIDONE AMNEAL LOT: 24050174 MFG: 02\/01\/24 EXP: 01\/31\/2","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NEWARK APT\/NEW YORK","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.005","unit":"KGS","unitRateFc":"78731.2","totalValueFC":"398.2","currency":"USD","unitRateINR":"6680346","date":"31-Aug-2024","totalValueINR":"33401.73","totalValueInUsd":"398.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"5339965","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK APT\/NEW YORK","supplierAddress":"50 HORSEBLOCK RD NY, 11719 11719 US","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733509800,"product":"PALIPERIDONE PALMITATE STERILE (LOT BATCH: 2403001P)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"N\/A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"66150","totalValueFC":"266720.7","currency":"USD","unitRateINR":"5665747.5","date":"07-Dec-2024","totalValueINR":"22662990","totalValueInUsd":"266720.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"7101102","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Sterile","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]
    04-Mar-2021
    30-Dec-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

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    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    INTERMEDIATE SUPPLIERS

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    01

    Anugraha Chemicals

    India
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    Anugraha Chemicals

    India
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    3-(2-Chloroethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-m...

    CAS Number : 130049-82-0

    End Use API : Paliperidone

    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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    02

    Aurore Life Sciences

    India
    Biotech Digital Meet
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    Aurore Life Sciences

    India
    Biotech Digital Meet
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    3-(2-Chloroethyl)-6,7,8,9 Tetra Hydro-9 Hydroxy-2-...

    CAS Number : 130049-82-0

    End Use API : Paliperidone

    About The Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in...

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    03

    Kalintis Healthcare

    India
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    Kalintis Healthcare

    India
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    1-Acetylpiperidine-4-carboxylic acid

    CAS Number : 25503-90-6

    End Use API : Paliperidone

    About The Company : Kalintis Healthcare is a vision with a drive to create a health-conscious Pharmaceuticals Company serving to bring Wellness to Humanity. We develop robust in-ho...

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    04

    MilverPharma Pvt Ltd

    India
    Biotech Digital Meet
    Not Confirmed
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    MilverPharma Pvt Ltd

    India
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    3-(2-Chloroethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-m...

    CAS Number : 130049-82-0

    End Use API : Paliperidone

    About The Company : MilverPharma Private Limited driven by Globally experienced management and highly qualified professionals. Our people have extensive and versatile experience in...

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    05

    Ocimum Labs

    India
    Biotech Digital Meet
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    Ocimum Labs

    India
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    3-(2-Chloroethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-m...

    CAS Number : 130049-82-0

    End Use API : Paliperidone

    About The Company : Ocimum Labs was founded in 2018 and started its R&D activities with a cutting-edge facility. The Hyderabad-based firm focuses on process research and developmen...

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    06

    Prajna Generics

    India
    Biotech Digital Meet
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    India
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    6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole

    CAS Number : 84163-77-9

    End Use API : Paliperidone

    About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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    Prajna Generics

    India
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    9-Benzyloxy-3-(2-Chloroethyl)-2-methyl pyrido[1,2-...

    CAS Number : 147687-17-0

    End Use API : Paliperidone

    About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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    08

    Prajna Generics

    India
    Biotech Digital Meet
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    Prajna Generics

    India
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    Methanone, (4-fluoro-2-hydroxyphenyl)-4- piperidin...

    CAS Number : 767582-67-2

    End Use API : Paliperidone

    About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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    09

    Prajna Generics

    India
    Biotech Digital Meet
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    3-(2-chloroethyl)-9-hydroxy-2-methyl-6,7,8,9- tetr...

    CAS Number : 130049-82-0

    End Use API : Paliperidone

    About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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    10

    Rampex Labs

    India
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    Rampex Labs

    India
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    6-Fluoro-3-(4-Piperidinyl)-1, 2-Benzisoxazole Hydr...

    CAS Number : CAS-84163-13-3

    End Use API : Paliperidone

    About The Company : We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with...

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21999

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21999

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 3MG

    USFDA APPLICATION NUMBER - 21999

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 6MG

    USFDA APPLICATION NUMBER - 21999

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 9MG

    USFDA APPLICATION NUMBER - 21999

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    ABOUT THIS PAGE

    Looking for 144598-75-4 / Paliperidone API manufacturers, exporters & distributors?

    Paliperidone manufacturers, exporters & distributors 1

    99

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

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

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

    API | Excipient name

    Paliperidone

    Synonyms

    144598-75-4, 9-hydroxyrisperidone, Invega, 9-oh-risperidone, 3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-4-one, Ro76477

    Cas Number

    144598-75-4

    Unique Ingredient Identifier (UNII)

    838F01T721

    About Paliperidone

    A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.

    Paliperidone Manufacturers

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

    Paliperidone Suppliers

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

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

    Paliperidone USDMF

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

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

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

    Paliperidone KDMF

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

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

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

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

    Paliperidone WC

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

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

    Paliperidone 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 Paliperidone as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Paliperidone GMP

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

    Paliperidone CoA

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

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

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