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7 RELATED EXCIPIENT COMPANIES

25EXCIPIENTS BY APPLICATIONS

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


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MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686853800,"product":"6904066 PALIPERIDONE PALMITATE MIC (FOR TESTING PURPOSE ONLY)","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"30000","totalValueFC":"33030.7","currency":"EUR","unitRateINR":"2715000.2","date":"16-Jun-2023","totalValueINR":"2715000.232","totalValueInUsd":"33030.7","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"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":1715884200,"product":"(N.C.V) PALIPERIDONE PALMITATE (FOR TESTING PURPOSE ONLY)","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"IRELAND","foreign_port":"DUBLIN","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"69.98","unit":"GMS","unitRateFc":"40","totalValueFC":"3106.3","currency":"EUR","unitRateINR":"3700","date":"17-May-2024","totalValueINR":"258926","totalValueInUsd":"3106.3","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3525235","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"LITTLE ISLAND INDUSTRIAL ESTATE LITTLE ISLAND CORK T45 P663 Little Island\/Cork, , Ireland Ireland","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 PVT. 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16-Aug-2021
30-Dec-2024
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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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