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Chemistry

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Also known as: 1083076-69-0, Cariprazine hcl, Vraylar, Rgh188 hydrochloride, Rgh-188 hcl, Cariprazine (hydrochloride)
Molecular Formula
C21H33Cl3N4O
Molecular Weight
463.9  g/mol
InChI Key
GPPJWWMREQHLQT-UHFFFAOYSA-N
FDA UNII
KQD7C255YG

Cariprazine Hydrochloride
1 2D Structure

Cariprazine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea;hydrochloride
2.1.2 InChI
InChI=1S/C21H32Cl2N4O.ClH/c1-25(2)21(28)24-17-8-6-16(7-9-17)10-11-26-12-14-27(15-13-26)19-5-3-4-18(22)20(19)23;/h3-5,16-17H,6-15H2,1-2H3,(H,24,28);1H
2.1.3 InChI Key
GPPJWWMREQHLQT-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(C)C(=O)NC1CCC(CC1)CCN2CCN(CC2)C3=C(C(=CC=C3)Cl)Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
KQD7C255YG
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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)

2.4 Create Date
2008-12-15
3 Chemical and Physical Properties
Molecular Weight 463.9 g/mol
Molecular Formula C21H33Cl3N4O
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count5
Exact Mass462.171995 g/mol
Monoisotopic Mass462.171995 g/mol
Topological Polar Surface Area38.8 Ų
Heavy Atom Count29
Formal Charge0
Complexity491
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Reagila is indicated for the treatment of schizophrenia in adult patients.


Treatment of schizophrenia


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.)


5.2 ATC Code

N05AX15


EU WC

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Cariprazine Hydrochloride IH

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. ...

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Cariprazine Hydrochloride IH

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...

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Cariprazine Hydrochloride IH

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...

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Cariprazine Hydrochloride IH

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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Virtual BoothDelivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.

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Cariprazine Hydrochloride

About the Company : Zeal Medipharma is a Star-rated Export House serving customers in over 50 countries for more than two decades. The company specializes in sourcing and exporting APIs for human and ...

Zeal Medipharma is a Star-rated Export House serving customers in over 50 countries for more than two decades. The company specializes in sourcing and exporting APIs for human and veterinary use, along with drug intermediates, excipients, and semi-finished forms such as pellets and DC granules. Its portfolio also includes herbal extracts, phytochemicals, nutraceuticals, food and feed ingredients, agrochemicals, preservatives, surfactants, and specialty chemicals, supporting global healthcare and industrial markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Cariprazine Hydrochloride

About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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HRV Pharma

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Cariprazine

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Cariprazine

About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...

Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compounds to NCEs and advanced intermediates. It manufactures APIs and intermediates in USFDA-approved facilities, applying advanced process chemistry in a regulatory-compliant environment for clinical and commercial stages. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Cariprazine Hydrochloride

About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...

Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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Cariprazine Hydrochloride

About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...

Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Through Honour Synthesis and Honour Specialty, it delivers innovative solutions leveraging chemistry expertise. Its team of over 2,500 professionals partners with pharmaceutical, biotech, and specialty industries worldwide to develop practical, scalable solutions. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Cariprazine Hydrochloride

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.
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Cariprazine Hydrochloride

About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
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Cariprazine Hydrochloride

About the Company : Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated mar...

Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated markets of USA, Europe, Russia, Canada and also for non-regulated markets. The first Morepen manufacturing plant was set up on the foothills of the Himalayas in the idyllic surroundings of Parwanoo. The large and spread-out facility is USDFA approved for manufacture of Loratadine, an anti-allergy drug- internationally known as Claritin.
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Nifty Labs

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Cariprazine Hydrochloride

About the Company : The company was founded by a technocrat Mr. D. Kesava Reddy in the year 2005. The Managing Director Mr. D. Kesava Reddy along with other three Board of Directors involved in contro...

The company was founded by a technocrat Mr. D. Kesava Reddy in the year 2005. The Managing Director Mr. D. Kesava Reddy along with other three Board of Directors involved in controlling the day to day operations of the company. The company has been focused on manufacturing and marketing of Bulk APIs (Bulk Drugs) and key Intermediates for APIs for Domestic and Global markets. About 60% is catered to domestic market and the rest 40% is catered to exports. The company does have a sister company named “Nifty Pharma Pvt. Ltd. located in Hyderabad focused on manufacturing & marketing of Semi-finished dosage forms.
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PU DONG","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"18000","totalValueFC":"1814.4","currency":"USD","unitRateINR":"1541700","date":"11-Dec-2024","totalValueINR":"154170","totalValueInUsd":"1814.4","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"7176696","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 , CHINA SDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734287400,"product":"CARIPRAZINE HYDROCHLORIDE","address":"20TH KM, HOSUR ROAD,","city":"BANGALORE","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"LINHAI, 33","customer":"BIOCON PHARMA LTD","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"16","totalValueFC":"3225.6","currency":"USD","unitRateINR":"1370.4","date":"16-Dec-2024","totalValueINR":"274080","totalValueInUsd":"3225.6","indian_port":"Biocon-SEZ","hs_no":"29420090","bill_no":"1016009","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINHAI, 33","supplierAddress":"LTD XUNQIAO LINHAI ZHEJIANG 317024CHINA CHINA","customerAddress":"20TH KM, HOSUR ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735151400,"product":"CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE","address":"IRIS- 1004, KESAR GARDEN, PLOT NO.","city":"NAVI MUMBAI.","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"V ENSURE PHARMA TECHNOLOGIES PRIVATE LTD","customerCountry":"INDIA","quantity":"9.70","actualQuantity":"9.7","unit":"KGS","unitRateFc":"10500","totalValueFC":"103025.9","currency":"USD","unitRateINR":"902475","date":"26-Dec-2024","totalValueINR":"8754007.5","totalValueInUsd":"103025.9","indian_port":"Bombay Air","hs_no":"29222990","bill_no":"7465695","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Xunqiao Linhai Zhejiang - 317024, , China SDNF China","customerAddress":"IRIS- 1004, KESAR GARDEN, PLOT NO."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754937000,"product":"CARIPRAZINE HYDROCHLORIDE IH","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR REDDY'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"14356.7","totalValueFC":"1453.4","currency":"USD","unitRateINR":"1272000","date":"12-Aug-2025","totalValueINR":"127200","totalValueInUsd":"1453.4","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29339990","bill_no":"3834367","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"FTO-7, PLOT NO.P1 TO P9, VSEZ, DUVV V.S.E.Z., DUVVADA, VISAKHAPATNAM SDNF India","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756665000,"product":"CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE","address":"FLAT NO 710,7TH FLOOR,,ADITYA TRAD","city":"HYDERABAD,TELANGANA","supplier":"APPCHEM LIMITED","supplierCountry":"HONG KONG","foreign_port":"HONG KONG","customer":"ANGENE CHEMICAL PRIVATE LTD","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"25","unit":"GMS","unitRateFc":"9.2","totalValueFC":"230.2","currency":"USD","unitRateINR":"812.7","date":"01-Sep-2025","totalValueINR":"20316.33","totalValueInUsd":"230.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4223086","productDescription":"API","marketType":"","country":"HONG KONG","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"ROOM 511, 5\/F, MING SANG INDUSTRIALBUILDING, 19-21 HING YIP STREET, KWUN TONG,KOWLOON,HONG KONG HK","customerAddress":"FLAT NO 710,7TH FLOOR,,ADITYA TRAD"}]
24-Jan-2022
12-Nov-2025
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

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FDF Dossiers

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01

AbbVie Inc

U.S.A

CARIPRAZINE HYDROCHLORIDE

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

Abbvie Company Banner

02

AbbVie Inc

U.S.A

CARIPRAZINE HYDROCHLORIDE

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

Abbvie Company Banner

03

AbbVie Inc

U.S.A

CARIPRAZINE HYDROCHLORIDE

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

Abbvie Company Banner

04

AbbVie Inc

U.S.A

CARIPRAZINE HYDROCHLORIDE

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

Abbvie Company Banner

05

AbbVie Inc

U.S.A

CARIPRAZINE HYDROCHLORIDE

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

Abbvie Company Banner

06

AbbVie Inc

U.S.A

CARIPRAZINE HYDROCHLORIDE

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

Abbvie Company Banner

07

AbbVie Inc

U.S.A

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

Abbvie Company Banner

08

AbbVie Inc

U.S.A

CARIPRAZINE (CARIPRAZINE HYDROCHLORIDE)

Brand Name : VRAYLAR

Dosage Form : CAPSULE

Dosage Strength : 3MG

Packaging :

Approval Date :

Application Number : 2526808

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

09

AbbVie Inc

U.S.A

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

Abbvie Company Banner

10

AbbVie Inc

U.S.A

CARIPRAZINE (CARIPRAZINE HYDROCHLORIDE)

Brand Name : VRAYLAR

Dosage Form : CAPSULE

Dosage Strength : 6MG

Packaging :

Approval Date :

Application Number : 2526824

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner
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Europe

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01

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Cariprazine Hydrochloride

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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02

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Cariprazine Hydrochloride

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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03

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Cariprazine Hydrochloride

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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04

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Cariprazine hydrochloride

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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05

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Kariprazine hydrochloride

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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06

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Kariprazine hydrochloride

Brand Name : Reagila

Dosage Form : Capsule

Dosage Strength : 6mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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07

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Cariprazine

Brand Name : Reagila

Dosage Form : Capsule

Dosage Strength : 45mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Cariprazine Hydrochloride

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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09

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
Not Confirmed

Cariprazine Hydrochloride

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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10

Recordati Ag

Italy
IMCAS World Congress
Not Confirmed
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Recordati Ag

Italy
arrow
IMCAS World Congress
Not Confirmed

Cariprazine

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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ABOUT THIS PAGE

Looking for 1083076-69-0 / Cariprazine Hydrochloride API manufacturers, exporters & distributors?

Cariprazine Hydrochloride manufacturers, exporters & distributors 1

86

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.

API | Excipient name

Cariprazine Hydrochloride

Synonyms

1083076-69-0, Cariprazine hcl, Vraylar, Rgh188 hydrochloride, Rgh-188 hcl, Cariprazine (hydrochloride)

Cas Number

1083076-69-0

Unique Ingredient Identifier (UNII)

KQD7C255YG

Cariprazine Manufacturers

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.

Cariprazine Suppliers

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.

Cariprazine USDMF

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.

Cariprazine WC

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.

Cariprazine 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 Cariprazine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cariprazine 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 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.

Compounded drug products

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 GMP

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.

Cariprazine CoA

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).

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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