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    Chemistry

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    Also known as: 199739-10-1, Invega sustenna, Xeplion, Invega trinza, Ro92670, Ro 92670
    Molecular Formula
    C39H57FN4O4
    Molecular Weight
    664.9  g/mol
    InChI Key
    VOMKSBFLAZZBOW-UHFFFAOYSA-N
    FDA UNII
    R8P8USM8FR
    Paliperidone Palmitate
    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.
    1 2D Structure

    Paliperidone Palmitate

    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]-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl] hexadecanoate
    2.1.2 InChI
    InChI=1S/C39H57FN4O4/c1-3-4-5-6-7-8-9-10-11-12-13-14-15-18-36(45)47-34-17-16-24-44-38(34)41-29(2)32(39(44)46)23-27-43-25-21-30(22-26-43)37-33-20-19-31(40)28-35(33)48-42-37/h19-20,28,30,34H,3-18,21-27H2,1-2H3
    2.1.3 InChI Key
    VOMKSBFLAZZBOW-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCCCCCCCCCCCCC(=O)OC1CCCN2C1=NC(=C(C2=O)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F)C
    2.2 Other Identifiers
    2.2.1 UNII
    R8P8USM8FR
    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

    11. Palmitate, Paliperidone

    12. R 76477

    13. R-76477

    14. R76477

    15. Sustenna, Invega

    2.3.2 Depositor-Supplied Synonyms

    1. 199739-10-1

    2. Invega Sustenna

    3. Xeplion

    4. Invega Trinza

    5. Ro92670

    6. Ro 92670

    7. Paliperidone Palmitate [usan]

    8. R8p8usm8fr

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

    10. Jns010

    11. Hexadecanoic Acid, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-4-oxo-4h-pyrido(1,2-a)pyrimidin-9-yl Ester

    12. Chebi:83808

    13. Jns-010

    14. Ro-92670

    15. R092670

    16. (9rs)-3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido(1,2-a)pyrimidin-9-yl Hexadecanoate

    17. 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-9-yl Hexadecanoate

    18. R-092670

    19. Trinza

    20. [3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl] Hexadecanoate

    21. Hexadecanoic Acid, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4h-pyrido[1,2-a]pyrimidin-9-yl Ester

    22. Unii-r8p8usm8fr

    23. 9-hydroxyrisperidone Palmitate

    24. Jns 010

    25. Pp3m

    26. Paliperidone Janssen

    27. Palperidone Palmitate

    28. Paliperidone Palmitate-[d4]

    29. Schembl1871384

    30. Chembl2107360

    31. Schembl12415674

    32. Hy-a0019a

    33. Dtxsid70870217

    34. Paliperidone Palmitate [mi]

    35. Bcp08473

    36. Paliperidone Palmitate [jan]

    37. Mfcd24386477

    38. S5624

    39. Paliperidone Palmitate [vandf]

    40. Paliperidone Palmitate [mart.]

    41. Paliperidone Palmitate [who-dd]

    42. Sb17398

    43. Ncgc00522023-01

    44. Paliperidone Palmitate [ema Epar]

    45. Ac-32485

    46. As-77089

    47. Paliperidone Palmitate [orange Book]

    48. Cs-0016387

    49. Ft-0673476

    50. D83646

    51. Q27157250

    52. 3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-9-ylpalmitate

    53. 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl Hexadecanoate

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 664.9 g/mol
    Molecular Formula C39H57FN4O4
    XLogP310.1
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count20
    Exact Mass664.43638447 g/mol
    Monoisotopic Mass664.43638447 g/mol
    Topological Polar Surface Area88.2 Ų
    Heavy Atom Count48
    Formal Charge0
    Complexity1090
    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 Indication

    Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.

    In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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.)

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Atypical Antipsychotic [EPC]
    5.3 ATC Code

    N05AX13

    API Reference Price

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SAS","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"85.56","actualQuantity":"85.56","unit":"KGS","unitRateFc":"12777.9","totalValueFC":"1217889","currency":"EURO","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 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MAHARASHTRA.","supplier":"JANSSEN PHARMACEUTICA NV","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON JOHNSON PRIVATE LTD","customerCountry":"INDIA","quantity":"0.04","actualQuantity":"42","unit":"GMS","unitRateFc":"40","totalValueFC":"1825.7","currency":"EURO","unitRateINR":"3630","date":"27-Apr-2024","totalValueINR":"152460","totalValueInUsd":"1825.7","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":1721586600,"product":"PALIPERIDONE PALMITATE (STERILE)","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"INTERQIM S A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"JODAS EXPOIM PRIVATE LTD","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"70000","totalValueFC":"3881.4","currency":"EURO","unitRateINR":"6489000","date":"22-Jul-2024","totalValueINR":"324450","totalValueInUsd":"3881.4","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4632832","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Sterile","supplierPort":"BARCELONA","supplierAddress":"JOAN BUSCALLA 10 08173 SANT CUGAT DEL VALLES BARCELONASDNF Spain","customerAddress":"101, SITARAM MANSION,"},{"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 S A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS PRIVATE LTD","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":"2025","qtr":"Q1","strtotime":1741804200,"product":"(N.C.V.) PALIPERIDONE PALMITATE, API (JNJ-16977831-AAA) 1 BOTTLE= 55.2G FOR TESTING PERPOSE ONLY(N.C.V.) PALIPERIDONE PALMITATE, API (JNJ-16977831-AAA) 1 BO","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JANSSEN PHARMACEUTICA NV","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON JOHNSON PRIVATE LTD","customerCountry":"INDIA","quantity":"0.11","actualQuantity":"110","unit":"GMS","unitRateFc":"43.6","totalValueFC":"4856.3","currency":"EURO","unitRateINR":"3824","date":"13-Mar-2025","totalValueINR":"420640","totalValueInUsd":"4856.3","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"8863532","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , B elgium SDNF Belgium","customerAddress":"30 FORJETT STREET"}]
    11-Apr-2022
    19-Sep-2025
    KGS
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    Average Price (USD/KGS)

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    Drugs in Development

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    • Development Update
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    Luye Launches ERZOFRI in U.S. for Schizophrenia and Schizoaffective

    Details:

    Erzofri (paliperidone palmitate) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Erzofri

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 06, 2025

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    01

    Luye Pharma

    China
    arrow
    AIChE Annual Meeting
    Not Confirmed

    Luye Pharma

    China
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    AIChE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Luye Launches ERZOFRI in U.S. for Schizophrenia and Schizoaffective

    Details : Erzofri (paliperidone palmitate) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.

    Product Name : Erzofri

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 06, 2025

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    Sumitomo to market Johnson & Johnson's schizophrenia drug in Japan

    Details:

    Under the collaboration, Sumitomo Pharma will conduct promotional activities in collaboration with Janssen for Xeplion (paliperidone palmitate) for the treatment of schizophrenia.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Xeplion

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Sumitomo Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration January 20, 2025

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    02

    Johnson & Johnson Innovative Medicine

    U.S.A
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    AIChE Annual Meeting
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    AIChE Annual Meeting
    Not Confirmed
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Sumitomo Pharma

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Sumitomo to market Johnson & Johnson's schizophrenia drug in Japan

    Details : Under the collaboration, Sumitomo Pharma will conduct promotional activities in collaboration with Janssen for Xeplion (paliperidone palmitate) for the treatment of schizophrenia.

    Product Name : Xeplion

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    January 20, 2025

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    Zydus Gets US Nod For Schizophrenia Generic Medicine

    Details:

    Paliperidone is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 10, 2024

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    03

    Zydus Lifesciences

    India
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    AIChE Annual Meeting
    Not Confirmed

    Zydus Lifesciences

    India
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    AIChE Annual Meeting
    Not Confirmed
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zydus Gets US Nod For Schizophrenia Generic Medicine

    Details : Paliperidone is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.

    Product Name : Invega-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 10, 2024

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    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details:

    Invega (paliperidone) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of patients with schizophrenia and schizoaffective disorder.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 27, 2024

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    04

    Alembic Pharmaceuticals Limited

    India
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    AIChE Annual Meeting
    Not Confirmed

    Alembic Pharmaceuticals Limited

    India
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    Not Confirmed
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details : Invega (paliperidone) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of patients with schizophrenia and schizoaffective disorder.

    Product Name : Invega-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 27, 2024

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    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details:

    Paliperidone extended-release tablets are used to treat the symptoms of psychotic disorders, including schizophrenia both as a monotherapy and as an adjunct to mood stabilizers and antidepressants.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 27, 2024

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    05

    Alembic Pharmaceuticals Limited

    India
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    AIChE Annual Meeting
    Not Confirmed

    Alembic Pharmaceuticals Limited

    India
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    AIChE Annual Meeting
    Not Confirmed
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details : Paliperidone extended-release tablets are used to treat the symptoms of psychotic disorders, including schizophrenia both as a monotherapy and as an adjunct to mood stabilizers and antidepressants.

    Product Name : Invega-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 27, 2024

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    Luye Pharma Announces FDA Approval of ERZOFRI for Schizophrenia & Schizoaffective Disorder

    Details:

    Erzofri (paliperidone palmitate) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 28, 2024

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    06

    Luye Pharma

    China
    arrow
    AIChE Annual Meeting
    Not Confirmed

    Luye Pharma

    China
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    AIChE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Luye Pharma Announces FDA Approval of ERZOFRI for Schizophrenia & Schizoaffective Disorder

    Details : Erzofri (paliperidone palmitate) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 28, 2024

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    Luye Pharma's Meibirui Approved in China For Treating Schizophrenia

    Details:

    Meibirui (paliperidone palmitate injection) has been approved for marketing by China’s NMPA, to be used for the acute and maintenance treatment of schizophrenia.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 11, 2024

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    07

    Luye Pharma

    China
    arrow
    AIChE Annual Meeting
    Not Confirmed

    Luye Pharma

    China
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    AIChE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Luye Pharma's Meibirui Approved in China For Treating Schizophrenia

    Details : Meibirui (paliperidone palmitate injection) has been approved for marketing by China’s NMPA, to be used for the acute and maintenance treatment of schizophrenia.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 11, 2024

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    Camber Pharmaceuticals Launches Generic Invega

    Details:

    Paliperidone extended-release tablets are used to treat the symptoms of psychotic disorders, including schizophrenia both as a monotherapy and as an adjunct to mood stabilizers and antidepressants.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 12, 2024

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    08

    Camber Pharmaceuticals

    U.S.A
    arrow
    AIChE Annual Meeting
    Not Confirmed

    Camber Pharmaceuticals

    U.S.A
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    AIChE Annual Meeting
    Not Confirmed
    • fda
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    • WHO-GMP
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Camber Pharmaceuticals Launches Generic Invega

    Details : Paliperidone extended-release tablets are used to treat the symptoms of psychotic disorders, including schizophrenia both as a monotherapy and as an adjunct to mood stabilizers and antidepressants.

    Product Name : Invega-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    February 12, 2024

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    Qilu Launches First Generic Version of Invega Sustenna® in China

    Details:

    Invega Sustenna is a monthly long-acting atypical antipsychotic medication used to treat schizophrenia and schizoaffective disorder.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Invega Sustenna-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 12, 2023

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    09

    Qilu Pharmaceutical

    China
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    Qilu Pharmaceutical

    China
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    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Qilu Launches First Generic Version of Invega Sustenna® in China

    Details : Invega Sustenna is a monthly long-acting atypical antipsychotic medication used to treat schizophrenia and schizoaffective disorder.

    Product Name : Invega Sustenna-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 12, 2023

    blank

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    #PipelineProspector

    Data Compilation
    #PharmaFlow

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    • fda
    • EDQM
    • WHO-GMP
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    NDA For Luye Pharma’s Paliperidone Palmitate Submitted in The U.S.

    Details:

    Erzofri (paliperidone palmitate) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.


    Lead Product(s): Paliperidone Palmitate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 09, 2023

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    10

    Luye Pharma

    China
    arrow
    AIChE Annual Meeting
    Not Confirmed

    Luye Pharma

    China
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    AIChE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.

    Lead Product(s) : Paliperidone Palmitate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NDA For Luye Pharma’s Paliperidone Palmitate Submitted in The U.S.

    Details : Erzofri (paliperidone palmitate) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of schizophrenia and schizoaffective disorder.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 09, 2023

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    ABOUT THIS PAGE

    Looking for 199739-10-1 / Paliperidone Palmitate API manufacturers, exporters & distributors?

    Paliperidone Palmitate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Paliperidone Palmitate

    Synonyms

    199739-10-1, Invega sustenna, Xeplion, Invega trinza, Ro92670, Ro 92670

    Cas Number

    199739-10-1

    Unique Ingredient Identifier (UNII)

    R8P8USM8FR

    About Paliperidone Palmitate

    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 Palmitate Manufacturers

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

    Paliperidone Palmitate Suppliers

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

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

    Paliperidone Palmitate USDMF

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

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

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

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

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

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

    Paliperidone Palmitate WC

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

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

    Paliperidone Palmitate 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 Palmitate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Paliperidone Palmitate GMP

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

    Paliperidone Palmitate CoA

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

    Paliperidone Palmitate CoA mostly includes findings from lab analyses of a specific batch. For each Paliperidone Palmitate 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 Palmitate may be tested according to a variety of international standards, such as European Pharmacopoeia (Paliperidone Palmitate EP), Paliperidone Palmitate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Paliperidone Palmitate 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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