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VRAYLAR

Megafine Pharma Cariprazine Hydrochloride RMU

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 9 USDMF, 2 EU WC, 5 NDC API, 16 Listed Suppliers, $ API Reference Price

25 API Suppliers
9 USDMF
2 EU WC
5 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

28 FDF Dossiers, 12 FDA Orange Book, 8 Europe, 4 Australia, 4 South Africa

28 FDF Dossiers
12 FDA Orange Book
8 Europe
4 Australia
4 South Africa

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 7 DKSH, 6 Gangwal Healthcare, 4 ACG Worldwide, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 1 Kerry, 3 Lonza Capsugel, 5 Microlex e.U, 2 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 8 Roquette, 2 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Vasa Pharmachem

relatedExcipients
3 SPI Pharma
7 DKSH
6 Gangwal Healthcare
4 ACG Worldwide
2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Gangwal Chemicals
2 Ingredion Pharma Solutions
1 Kerry
3 Lonza Capsugel
5 Microlex e.U
2 Pluviaendo
1 Prachin Chemical
1 Qualicaps
8 Roquette
2 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

23 Fillers, Diluents & Binders, 9 Direct Compression, 8 Empty Capsules, 8 Lubricants & Glidants, 7 Coating Systems & Additives, 7 Thickeners and Stabilizers, 6 Co-Processed Excipients, 4 Taste Masking, 4 Disintegrants & Superdisintegrants, 3 Chewable & Orodispersible Aids, 3 Coloring Agents, 2 Controlled & Modified Release, 2 Film Formers & Plasticizers, 1 Emulsifying Agents, 1 Granulation

excipientsByApplications
23 Fillers, Diluents & Binders
9 Direct Compression
8 Empty Capsules
8 Lubricants & Glidants
7 Coating Systems & Additives
7 Thickeners and Stabilizers
6 Co-Processed Excipients
4 Taste Masking
4 Disintegrants & Superdisintegrants
3 Chewable & Orodispersible Aids
3 Coloring Agents
2 Controlled & Modified Release
2 Film Formers & Plasticizers
1 Emulsifying Agents
1 Granulation

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 38 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 8 Finished Drug Prices, 8 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
8 Finished Drug Prices
8 Annual Reports

MARKET PLACE

9 APIs

marketPlace
9 APIs

PATENTS & EXCLUSIVITIES

55 US Patents, 4 US Exclusivities

patents
55 US Patents
4 US Exclusivities

Megafine Pharma Cariprazine Hydrochloride Popup

Synopsis

ACTIVE PHARMA INGREDIENTS

25

API Suppliers

9

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

2

EU WC

0

KDMF

5

NDC API

0

VMF

16

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 20,255

MARKET PLACE

9

API

0

FDF

9INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

28

FDF Dossiers

12

FDA Orange Book

FDA (Orange Book)

8

Europe

0

Canada

4

Australia

4

South Africa

0

Listed Dossiers

5DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

55

US Patents

4

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

2

Data Compilation #PharmaFlow

1

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

38

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

708,765,555

Annual Reports (USD Million)

9,204

Finished Drug Prices

51 RELATED EXCIPIENT COMPANIES

88EXCIPIENTS BY APPLICATIONS

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 Formula	C₂₁H₃₃Cl₃N₄O
Molecular Weight	463.9 g/mol
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 Å²
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

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

API SUPPLIERS

01

Megafine Pharma (P) Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

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India

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Megafine Pharma

Product Web Link

Digital Content

Corporate PDF

02

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Product Web Link

Digital Content

03

Aptra Synthesis

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

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India

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Aptra Synthesis

Product Web Link

Digital Content

Corporate PDF

04

Chongqing Sintaho Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

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China

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Chongqing Sintaho Pharmaceutical

Product Web Link

Digital Content

Corporate PDF

05

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU

AUDIT

HRV Global Life Sciences

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Digital Content

06

Hubei Gedian Humanwell Pharmaceuti...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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China

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Hubei Gedian Humanwell Pharmaceutical

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Digital Content

07

Porton Pharma Solutions

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

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China

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Porton Company Banner

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Digital Content

08

Lee Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Discovery on Target

Not Confirmed

09

Gedeon Richter

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Discovery on Target

Not Confirmed

10

Zhejiang Huahai Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Discovery on Target

Not Confirmed

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USDMF

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EU WC

01

Sionc Pharmaceuticals

India

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Not Confirmed

02

Sionc Pharmaceuticals

India

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API Reference Price

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VERBEN S.A","supplierCountry":"SWITZERLAND","foreign_port":"BUENOS AIRES, BA","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"35000","totalValueFC":"5285.1","currency":"USD","unitRateINR":"2933000","date":"27-Dec-2023","totalValueINR":"439950","totalValueInUsd":"5285.1","indian_port":"Bombay Air","hs_no":"29222990","bill_no":"9432326","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Micronized","supplierPort":"BUENOS AIRES, BA","supplierAddress":"LIGANO BRANCHVIA F. 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Number of Transactions

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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