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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
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
Molecular Weight | 664.9 g/mol |
---|---|
Molecular Formula | C39H57FN4O4 |
XLogP3 | 10.1 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 20 |
Exact Mass | 664.43638447 g/mol |
Monoisotopic Mass | 664.43638447 g/mol |
Topological Polar Surface Area | 88.2 Ų |
Heavy Atom Count | 48 |
Formal Charge | 0 |
Complexity | 1090 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
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.
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.)
N05AX13
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Dosage Form (Strength) : POWDER (1kg/kg)
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Paliperidone Palmitate Sterile IH
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Paliperidone Palmitate Sterile IH
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Registration Date : 2010-05-27
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Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Turnhoutseweg 30, B-2340 Beerse, Belgium
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Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4063
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4063
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4063
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4076
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4063
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4076
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4076
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4063
Start Marketing Date : 2009-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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
Therapeutic Area: Psychiatry/Psychology Brand Name: Erzofri
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 06, 2025
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 06, 2025
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
Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 02, 2024
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
December 02, 2024
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
Therapeutic Area: Psychiatry/Psychology Brand Name: LY03010
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 06, 2024
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : LY03010
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 06, 2024
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
Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 10, 2024
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
October 10, 2024
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
Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 27, 2024
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
September 27, 2024
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
Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 27, 2024
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
September 27, 2024
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
Therapeutic Area: Psychiatry/Psychology Brand Name: LY03010
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 28, 2024
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : LY03010
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 28, 2024
Details:
Invega Sustenna is a monthly long-acting atypical antipsychotic medication used to treat schizophrenia and schizoaffective disorder.
Lead Product(s): Paliperidone Palmitate
Therapeutic Area: Psychiatry/Psychology Brand Name: Invega Sustenna-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 10, 2023
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
December 10, 2023
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
Therapeutic Area: Psychiatry/Psychology Brand Name: LY03010
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 10, 2023
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : LY03010
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 10, 2023
Details:
LY03010 (paliperidone palmitate) Prolonged Release Suspension for Injection is a central dopamine type 2 (D2) and serotonin type 2 (5HT2A) receptor antagonism which isused to treat schizophrenia.
Lead Product(s): Paliperidone Palmitate
Therapeutic Area: Psychiatry/Psychology Brand Name: LY03010
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 23, 2023
Lead Product(s) : Paliperidone Palmitate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : LY03010 (paliperidone palmitate) Prolonged Release Suspension for Injection is a central dopamine type 2 (D2) and serotonin type 2 (5HT2A) receptor antagonism which isused to treat schizophrenia.
Product Name : LY03010
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 23, 2023
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 25MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 50MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 75MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 100MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 150MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 175MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 263MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 350MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 525MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 700MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
RLD : Yes
TE Code :
Brand Name : INVEGA TRINZA
Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Dosage Strength : 410MG/1.315ML (311.79MG/ML)
Approval Date : 2015-05-18
Application Number : 207946
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : INVEGA TRINZA
Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Dosage Strength : 546MG/1.75ML (312MG/ML)
Approval Date : 2015-05-18
Application Number : 207946
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : INVEGA TRINZA
Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Dosage Strength : 819MG/2.625ML (312MG/ML)
Approval Date : 2015-05-18
Application Number : 207946
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : PALIPERIDONE PALMITATE
Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Dosage Strength : 234MG/1.5ML (156MG/ML)
Approval Date : 2021-07-06
Application Number : 211149
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Brand Name : PALIPERIDONE PALMITATE
Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Dosage Strength : 39MG/0.25ML
Approval Date :
Application Number : 211995
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : PALIPERIDONE PALMITATE
Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Dosage Strength : 78MG/0.5ML
Approval Date :
Application Number : 211995
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : PALIPERIDONE PALMITATE
Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Dosage Strength : 117MG/0.75ML
Approval Date :
Application Number : 211995
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : PALIPERIDONE PALMITATE
Dosage Form : INJECTION;SUSPENSION
Dosage Strength : 546MG/1.75ML
Approval Date :
Application Number : 215682
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : PALIPERIDONE PALMITATE
Dosage Form : INJECTION;SUSPENSION
Dosage Strength : 819MG/2.625ML
Approval Date :
Application Number : 215682
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : PALIPERIDONE PALMITATE
Dosage Form : INJECTION;SUSPENSION
Dosage Strength : 1092MG/3.5ML
Approval Date :
Application Number : 215682
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Norway
Brand Name : Palmeux
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 150 mg
Packaging : Pre-filled syringe 1 150mg, item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Palmeux
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 75 mg
Packaging : Pre-filled syringe 1 75mg, item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xeplion
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 50 mg
Packaging : Pre-filled syringe 50mg, item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xeplion
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 100 mg
Packaging : Pre-filled syringe 100mg, item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xeplion
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 75 mg
Packaging : Pre-filled syringe 75mg, item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Trevicta
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 350 mg
Packaging : Pre-filled syringe 1 1.75ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Trevicta
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 525 mg
Packaging : Pre-filled syringe 1 2.625ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xeplion
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 150 mg
Packaging : Pre-filled syringe 150mg, item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Trevicta
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 175 mg
Packaging : Pre-filled syringe 1 0.875ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xeplion
Dosage Form : Depot solution for injection, suspension
Dosage Strength : 100 mg
Packaging : Pre-filled syringe 1item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA SUSTENNA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 50MG/0.5ML
Packaging :
Approval Date :
Application Number : 2354217
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA SUSTENNA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 75MG/0.75ML
Packaging :
Approval Date :
Application Number : 2354225
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA SUSTENNA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 100MG/1ML
Packaging :
Approval Date :
Application Number : 2354233
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA SUSTENNA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 150MG/1.5ML
Packaging :
Approval Date :
Application Number : 2354241
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA TRINZA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 175MG/0.875ML
Packaging : 0.875ML
Approval Date :
Application Number : 2455943
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA TRINZA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 263MG/1.315ML
Packaging : 1.315ML
Approval Date :
Application Number : 2455986
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA TRINZA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 350MG/1.75ML
Packaging : 1.75ML
Approval Date :
Application Number : 2455994
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PALIPERIDONE (PALIPERIDONE PALMITATE)
Brand Name : INVEGA TRINZA
Dosage Form : SUSPENSION (EXTENDED-RELEASE)
Dosage Strength : 525MG/2.625ML
Packaging : 2.625ML
Approval Date :
Application Number : 2456001
Regulatory Info : Prescription
Registration Country : Canada
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27
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).