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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
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33846
Submission : 2019-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-23
Pay. Date : 2019-06-26
DMF Number : 33956
Submission : 2019-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26321
Submission : 2012-07-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38749
Submission : 2023-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-14
Pay. Date : 2019-03-15
DMF Number : 33623
Submission : 2019-03-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33399
Submission : 2018-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-31
Pay. Date : 2019-07-18
DMF Number : 33834
Submission : 2019-07-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-14
Pay. Date : 2023-09-27
DMF Number : 38933
Submission : 2023-09-26
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40029
Submission : 2024-06-28
Status : Active
Type : II
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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 VRAYLAR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of VRAYLAR, including repackagers and relabelers. The FDA regulates VRAYLAR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. VRAYLAR 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 VRAYLAR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A VRAYLAR supplier is an individual or a company that provides VRAYLAR active pharmaceutical ingredient (API) or VRAYLAR finished formulations upon request. The VRAYLAR suppliers may include VRAYLAR API manufacturers, exporters, distributors and traders.
click here to find a list of VRAYLAR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A VRAYLAR DMF (Drug Master File) is a document detailing the whole manufacturing process of VRAYLAR active pharmaceutical ingredient (API) in detail. Different forms of VRAYLAR DMFs exist exist since differing nations have different regulations, such as VRAYLAR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A VRAYLAR DMF submitted to regulatory agencies in the US is known as a USDMF. VRAYLAR USDMF includes data on VRAYLAR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The VRAYLAR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of VRAYLAR suppliers with USDMF on PharmaCompass.
A VRAYLAR written confirmation (VRAYLAR WC) is an official document issued by a regulatory agency to a VRAYLAR manufacturer, verifying that the manufacturing facility of a VRAYLAR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting VRAYLAR APIs or VRAYLAR finished pharmaceutical products to another nation, regulatory agencies frequently require a VRAYLAR WC (written confirmation) as part of the regulatory process.
click here to find a list of VRAYLAR 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 VRAYLAR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for VRAYLAR 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 VRAYLAR 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 VRAYLAR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a VRAYLAR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of VRAYLAR suppliers with NDC on PharmaCompass.
VRAYLAR 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 VRAYLAR 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 VRAYLAR GMP manufacturer or VRAYLAR GMP API supplier for your needs.
A VRAYLAR CoA (Certificate of Analysis) is a formal document that attests to VRAYLAR's compliance with VRAYLAR specifications and serves as a tool for batch-level quality control.
VRAYLAR CoA mostly includes findings from lab analyses of a specific batch. For each VRAYLAR 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.
VRAYLAR may be tested according to a variety of international standards, such as European Pharmacopoeia (VRAYLAR EP), VRAYLAR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (VRAYLAR USP).