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1. 3-(trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-1,1-dimethylurea
2. Cariprazine
3. Cariprazine Hcl
4. N'-(trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-n,n-dimethylurea Monohydrochloride
5. Rgh-188
6. Trans-4-(2-(4-(2,3-dichlorophenyl)piperazine-1-yl)-ethyl)-n,n-dimethylcarbamoyl-cyclohexyl-amine Hydrochloride
7. Vraylar
1. 1083076-69-0
2. Cariprazine Hcl
3. Vraylar
4. Rgh188 Hydrochloride
5. Rgh-188 Hcl
6. Cariprazine (hydrochloride)
7. Cariprazine Hydrochloride [usan]
8. Kqd7c255yg
9. Mfcd26142670
10. 3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea;hydrochloride
11. Unii-kqd7c255yg
12. Cariprazine.hcl
13. Vraylar (tn)
14. Cariprazine Hydrochloride (jan/usan)
15. Cariprazine Monohydrochloride
16. Schembl183803
17. Schembl183804
18. Chembl2024517
19. Chebi:90932
20. Dtxsid101026486
21. Bcp24194
22. Ex-a1644
23. Hy-14763a
24. S5849
25. Cariprazine Hydrochloride [mi]
26. Cariprazine Hydrochloride [jan]
27. Cs-1570
28. Sb16840
29. 3-[trans-4-[2-[4-(2,3-dichlorophenyl)-1-piperazinyl]ethyl]cyclohexyl]-1,1-dimethylurea Hydrochloride
30. Ac-33130
31. Cariprazine Hydrochloride [who-dd]
32. Sy039271
33. Ft-0701196
34. A15036
35. Cariprazine Hydrochloride [orange Book]
36. D09876
37. A857936
38. Q27162922
39. 3-((1r,4r)-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-1,1-dimethylurea Hydrochloride
40. N'-(trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-n,n-dimethylurea Monohydrochloride
41. N'-(trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-n,n-dimthylurea Monohydrochloride
42. N'-(trans-4-{2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl}cyclohexyl)-n,n-dimethylurea Hydrochloride
43. N'-[trans-4-[2-[4-(2,3-dichlorophenyl)-1-piperazinyl]ethyl]cyclohexyl]-n,n-dimethylurea Hydrochloride
44. Urea, N'-(trans-4-(2-(4-(2,3-dichlorophenyl)-1-piperazinyl)ethyl)cyclohexyl)-n,n- Dimethyl-, Hydrochloride (1:1)
| Molecular Weight | 463.9 g/mol |
|---|---|
| Molecular Formula | C21H33Cl3N4O |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 5 |
| Exact Mass | 462.171995 g/mol |
| Monoisotopic Mass | 462.171995 g/mol |
| Topological Polar Surface Area | 38.8 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 491 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Reagila is indicated for the treatment of schizophrenia in adult patients.
Treatment of schizophrenia
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.)
N05AX15
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No\'s. ...

Date of Issue : 2025-07-07
Valid Till : 2028-07-14
Written Confirmation Number : WC-0021
Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...

Date of Issue : 2023-11-15
Valid Till : 2026-05-11
Written Confirmation Number : WC-0273
Address of the Firm : Plot No: 34A, Road No: 1, Jawaharlal Nehru Pharma City, Thanam Village, Parawada...

Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm : Plot No. 24/2, & 25, Phase -IV, GIDC Industrial Zone, At & Post - Panoli, Dist.-...

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Average Price (USD/KGS) |
Number of Transactions |
|---|
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Regulatory Info : RX
Registration Country : USA
Brand Name : VRAYLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 1.5MG BASE
Packaging :
Approval Date : 2015-09-17
Application Number : 204370
Regulatory Info : RX
Registration Country : USA
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Regulatory Info : RX
Registration Country : USA
Brand Name : VRAYLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 3MG BASE
Packaging :
Approval Date : 2015-09-17
Application Number : 204370
Regulatory Info : RX
Registration Country : USA
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Regulatory Info : RX
Registration Country : USA
Brand Name : VRAYLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 4.5MG BASE
Packaging :
Approval Date : 2015-09-17
Application Number : 204370
Regulatory Info : RX
Registration Country : USA
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Regulatory Info : RX
Registration Country : USA
Brand Name : VRAYLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 6MG BASE
Packaging :
Approval Date : 2015-09-17
Application Number : 204370
Regulatory Info : RX
Registration Country : USA
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Regulatory Info : RX
Registration Country : USA
Brand Name : VRAYLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2025-12-18
Application Number : 204370
Regulatory Info : RX
Registration Country : USA
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Regulatory Info : RX
Registration Country : USA
Brand Name : VRAYLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.75MG BASE
Packaging :
Approval Date : 2025-12-18
Application Number : 204370
Regulatory Info : RX
Registration Country : USA
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Regulatory Info : Prescription
Registration Country : Canada
CARIPRAZINE (CARIPRAZINE HYDROCHLORIDE)
Brand Name : VRAYLAR
Dosage Form : CAPSULE
Dosage Strength : 1.5MG
Packaging :
Approval Date :
Application Number : 2526794
Regulatory Info : Prescription
Registration Country : Canada
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Regulatory Info : Prescription
Registration Country : Canada
CARIPRAZINE (CARIPRAZINE HYDROCHLORIDE)
Brand Name : VRAYLAR
Dosage Form : CAPSULE
Dosage Strength : 3MG
Packaging :
Approval Date :
Application Number : 2526808
Regulatory Info : Prescription
Registration Country : Canada
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Regulatory Info : Prescription
Registration Country : Canada
CARIPRAZINE (CARIPRAZINE HYDROCHLORIDE)
Brand Name : VRAYLAR
Dosage Form : CAPSULE
Dosage Strength : 4.5MG
Packaging :
Approval Date :
Application Number : 2526816
Regulatory Info : Prescription
Registration Country : Canada
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Registration Country : Canada
CARIPRAZINE (CARIPRAZINE HYDROCHLORIDE)
Brand Name : VRAYLAR
Dosage Form : CAPSULE
Dosage Strength : 6MG
Packaging :
Approval Date :
Application Number : 2526824
Regulatory Info : Prescription
Registration Country : Canada
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Reagila
Dosage Form : Capsule
Dosage Strength :
Packaging :
Approval Date : 13/07/2017
Application Number : 20160305000083
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Reagila
Dosage Form : Capsule
Dosage Strength : 4.5mg
Packaging :
Approval Date : 13/07/2017
Application Number : 20160305000090
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Reagila
Dosage Form : Orodispersible Tablet
Dosage Strength :
Packaging :
Approval Date : 01/08/2024
Application Number : 20230627000044
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info :
Registration Country : Moldova
Brand Name : Reagila®
Dosage Form : Capsule
Dosage Strength :
Packaging :
Approval Date : 02-10-2023
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Reagila
Dosage Form : Capsule
Dosage Strength : 1.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Reagila
Dosage Form : Capsule
Dosage Strength : 6mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Reagila
Dosage Form : Capsule
Dosage Strength : 45mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : React
Dosage Form : Hard Capsule
Dosage Strength : 4.5MG
Packaging :
Approval Date : 12-02-2018
Application Number : 1171209021
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : React
Dosage Form : Hard Capsule
Dosage Strength : 6MG
Packaging :
Approval Date : 12-02-2018
Application Number : 1171209029
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Reagila
Dosage Form : Hard Capsule
Dosage Strength : 1.5mg
Packaging :
Approval Date : 19/06/2018
Application Number : 66364
Regulatory Info : Allowed
Registration Country : Switzerland

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PharmaCompass offers a list of Cariprazine Hydrochloride 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 Cariprazine Hydrochloride manufacturer or Cariprazine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cariprazine Hydrochloride manufacturer or Cariprazine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Cariprazine Hydrochloride API Price utilized in the formulation of products. Cariprazine Hydrochloride API Price is not always fixed or binding as the Cariprazine Hydrochloride Price is obtained through a variety of data sources. The Cariprazine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cariprazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cariprazine, including repackagers and relabelers. The FDA regulates Cariprazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cariprazine 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 Cariprazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cariprazine supplier is an individual or a company that provides Cariprazine active pharmaceutical ingredient (API) or Cariprazine finished formulations upon request. The Cariprazine suppliers may include Cariprazine API manufacturers, exporters, distributors and traders.
click here to find a list of Cariprazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cariprazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cariprazine active pharmaceutical ingredient (API) in detail. Different forms of Cariprazine DMFs exist exist since differing nations have different regulations, such as Cariprazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cariprazine DMF submitted to regulatory agencies in the US is known as a USDMF. Cariprazine USDMF includes data on Cariprazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cariprazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cariprazine suppliers with USDMF on PharmaCompass.
A Cariprazine written confirmation (Cariprazine WC) is an official document issued by a regulatory agency to a Cariprazine manufacturer, verifying that the manufacturing facility of a Cariprazine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cariprazine APIs or Cariprazine finished pharmaceutical products to another nation, regulatory agencies frequently require a Cariprazine WC (written confirmation) as part of the regulatory process.
click here to find a list of Cariprazine 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 Cariprazine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cariprazine 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 Cariprazine 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 Cariprazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cariprazine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cariprazine suppliers with NDC on PharmaCompass.
Cariprazine 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 Cariprazine 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 Cariprazine GMP manufacturer or Cariprazine GMP API supplier for your needs.
A Cariprazine CoA (Certificate of Analysis) is a formal document that attests to Cariprazine's compliance with Cariprazine specifications and serves as a tool for batch-level quality control.
Cariprazine CoA mostly includes findings from lab analyses of a specific batch. For each Cariprazine 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.
Cariprazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Cariprazine EP), Cariprazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cariprazine USP).