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Also known as: 960203-27-4, Vortioxetine hbr, Brintellix, Vortioxetine (lu aa21004) hbr, Trintellix, Vortioxetine (hydrobromide)
Molecular Formula
C18H23BrN2S
Molecular Weight
379.4  g/mol
InChI Key
VNGRUFUIHGGOOM-UHFFFAOYSA-N
FDA UNII
TKS641KOAY

Vortioxetine Hydrobromide
A piperazine derivative that acts as a serotonin reuptake inhibitor, as a 5-HT3 receptor antagonist, and 5-HT1A receptor agonist. It is used for the treatment of anxiety and depression.
1 2D Structure

Vortioxetine Hydrobromide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide
2.1.2 InChI
InChI=1S/C18H22N2S.BrH/c1-14-7-8-17(15(2)13-14)21-18-6-4-3-5-16(18)20-11-9-19-10-12-20;/h3-8,13,19H,9-12H2,1-2H3;1H
2.1.3 InChI Key
VNGRUFUIHGGOOM-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC(=C(C=C1)SC2=CC=CC=C2N3CCNCC3)C.Br
2.2 Other Identifiers
2.2.1 UNII
TKS641KOAY
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(2-(2,4-dimethylphenylsulfanyl)phenyl)piperazine

2. Brintellix

3. Lu Aa21004

4. Lu-aa21004

5. Luaa21004

6. Vortioxetine

2.3.2 Depositor-Supplied Synonyms

1. 960203-27-4

2. Vortioxetine Hbr

3. Brintellix

4. Vortioxetine (lu Aa21004) Hbr

5. Trintellix

6. Vortioxetine (hydrobromide)

7. Unii-tks641koay

8. Lu Aa 21004 Hydrobromide

9. Vortioxetine Hydrobromide [usan]

10. Lu Aa21004 Hbr

11. Tks641koay

12. Lu-aa21004 Hydrobromide

13. Lu Aa21004 (hbr)

14. 1-(2-((2,4-dimethylphenyl)thio)phenyl)piperazine Hydrobromide

15. 960203-27-4 (hbr)

16. Chebi:76015

17. 1-(2-((2,4-dimethylphenyl)sulfanyl)phenyl)piperazine Monohydrobromide

18. Brintellix (tn)

19. 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine Hydrobromide

20. 1-[2-[(2,4-dimethylphenyl)thio]phenyl]piperazine Hydrobromide

21. Piperazine, 1-(2-((2,4-dimethylphenyl)thio)phenyl)-, Hydrobromide (1:1)

22. Trintellix (tn)

23. Voltiocetin Hydrobromide

24. Lu Aa21004 Hydrobromide

25. Vortioxetine Monohydrobromide

26. Schembl237653

27. Lu-aa21004 Hbr

28. Chembl2107387

29. Lu-aa-21004

30. Dtxsid501027850

31. Amy25254

32. Bcp09588

33. Ex-a2348

34. Hy-15414a

35. Mfcd22383961

36. S8021

37. Vortioxetine Hydrobromide (jan/usan)

38. Akos016340374

39. Ccg-268394

40. Cs-1472

41. Hg-0011

42. Sb16507

43. Vortioxetine Hydrobromide [jan]

44. Ac-28325

45. Vortioxetine (lu Aa21004) Hydrobromide

46. Vortioxetine Hydrobromide [who-dd]

47. 960203-27-4, Trintellix, Brintellix,

48. Ft-0696676

49. Sw219360-1

50. D10185

51. Vortioxetine Hydrobromide [orange Book]

52. A855301

53. Lu Aa 21004 Hydrobromide;lu Aa21004 Hydrobromide

54. Q27145682

55. 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine-hbr

56. 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide

57. 1-[2-[(2,4-dimethylphenyl)thio]phenyl]-piperazine Hydrobromide

58. 1-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazine Hydrobromide

59. 4-[2-(2,4-dimethyl-phenylsulfanyl)-phenyl]-piperazine Hydrobromide

60. 4-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazin-1-ium Bromide

2.3.3 Other Synonyms

1. Vortioxetine

2.4 Create Date
2012-03-21
3 Chemical and Physical Properties
Molecular Weight 379.4 g/mol
Molecular Formula C18H23BrN2S
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass378.07653 g/mol
Monoisotopic Mass378.07653 g/mol
Topological Polar Surface Area40.6 Ų
Heavy Atom Count22
Formal Charge0
Complexity316
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 Information
1 of 2  
Drug NameBrintellix
PubMed HealthMeclizine, Buclizine, and Cyclizine (Oral route, Parenteral route)
Drug LabelBRINTELLIX is an immediate-release tablet for oral administration that contains the beta () polymorph of vortioxetine hydrobromide (HBr), an antidepreant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazi...
Active IngredientVortioxetine hydrobromide
Dosage FormTablet
RouteOral
Strengtheq 15mg base; eq 5mg base; eq 20mg base; eq 10mg base
Market StatusPrescription
CompanyTakeda Pharms Usa

2 of 2  
Drug NameBrintellix
PubMed HealthMeclizine, Buclizine, and Cyclizine (Oral route, Parenteral route)
Drug LabelBRINTELLIX is an immediate-release tablet for oral administration that contains the beta () polymorph of vortioxetine hydrobromide (HBr), an antidepreant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazi...
Active IngredientVortioxetine hydrobromide
Dosage FormTablet
RouteOral
Strengtheq 15mg base; eq 5mg base; eq 20mg base; eq 10mg base
Market StatusPrescription
CompanyTakeda Pharms Usa

4.2 Drug Indication

Treatment of major depressive episodes in adults.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)


Antidepressive Agents

Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)


Selective Serotonin Reuptake Inhibitors

Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)


Serotonin 5-HT1 Receptor Agonists

Endogenous compounds and drugs that specifically stimulate SEROTONIN 5-HT1 RECEPTORS. Included under this heading are agonists for one or more of the specific 5-HT1 receptor subtypes. (See all compounds classified as Serotonin 5-HT1 Receptor Agonists.)


Serotonin 5-HT3 Receptor Antagonists

Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)


5.2 ATC Code

N06AX26


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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"ACTIVE PHARMACEUTICALS INGREDIENT (PHARMACEUTICAL RAW MATERIAL FOR PHARMA INDUSTRIES) NAME - VORTIOXETINE (D, L) LACTATE","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"\\\"TO THE ORDER OF\\\"","customerCountry":"GREECE","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3000","totalValueFC":"2725.1","currency":"USD","unitRateINR":236985.14000000001,"date":"24-Feb-2025","totalValueINR":"236985.14","totalValueInUsd":"2725.1","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"8464833","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740681000,"product":"VORTIOXETINE HYDROBROMIDE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE MUTUAL TRUST BANK","customerCountry":"BANGLADESH","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"4950","totalValueFC":"6357.5","currency":"USD","unitRateINR":368580.83333333331,"date":"28-Feb-2025","totalValueINR":"552871.25","totalValueInUsd":"6357.5","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"8590593","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652725800,"product":"VORTIOXETINE HYDROBROMIDE (VORTIOXETINE HYDROBROMIDE IN-HOUSE)","address":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ ITHA","city":"AMRITSAR,PUNJAB","supplier":"AFINE CHEMICALS LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"KWALITY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"4000","totalValueFC":"996.9","currency":"USD","unitRateINR":"308200","date":"17-May-2022","totalValueINR":"77050","totalValueInUsd":"996.9","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"8716520","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ ITHA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"VORTIOXETINE HYDROBROMIDE (TEST LICENCE FORM CT-1T NO.SW\/ND\/CT-17\/2024\/00003006 DT.22\/07\/2024)","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"MEDREICH","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"3000","totalValueFC":"15129","currency":"USD","unitRateINR":"253800","date":"03-Aug-2024","totalValueINR":"1269000","totalValueInUsd":"15129","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"4853446","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"LTD. XUNQIAO, LINHAIZHEJIANG 317024SDNF CHINA","customerAddress":"MEDREICH HOUSE, NO12\/8,"}]
18-Feb-2021
28-Feb-2025
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Average Price (USD/KGS)

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

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Listed Dossiers

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Vortioxetine

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Registration Country : Spain

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Vortioxetine

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Registration Country : Spain

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03

Peptide Therapy Summit
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Vortioxetine

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Dosage Form : Film Coated Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Peptide Therapy Summit
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Vortioxetine

Dosage : Film Coated Tablet

Dosage Strength : 15MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Spain

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Peptide Therapy Summit
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Vortioxetine

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Peptide Therapy Summit
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Vortioxetine

Dosage : Film Coated Tablet

Dosage Strength : 20MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Spain

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05

TECNIMEDE

Portugal
Peptide Therapy Summit
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Portugal
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Vortioxetine

Brand Name :

Dosage Form : Oral Solution

Dosage Strength : 20MG/ML

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Approval Date :

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Registration Country : Portugal

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TECNIMEDE

Portugal
Peptide Therapy Summit
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Portugal
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Vortioxetine

Dosage : Oral Solution

Dosage Strength : 20MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Portugal

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06

TECNIMEDE

Portugal
Peptide Therapy Summit
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Portugal
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Vortioxetine

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

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TECNIMEDE

Portugal
Peptide Therapy Summit
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Portugal
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Vortioxetine

Dosage : Film Coated Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Portugal

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07

TECNIMEDE

Portugal
Peptide Therapy Summit
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TECNIMEDE

Portugal
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Peptide Therapy Summit
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Vortioxetine

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

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07

TECNIMEDE

Portugal
Peptide Therapy Summit
Not Confirmed
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TECNIMEDE

Portugal
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Peptide Therapy Summit
Not Confirmed

Vortioxetine

Dosage : Film Coated Tablet

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Portugal

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08

TECNIMEDE

Portugal
Peptide Therapy Summit
Not Confirmed
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TECNIMEDE

Portugal
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Peptide Therapy Summit
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Vortioxetine

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

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08

TECNIMEDE

Portugal
Peptide Therapy Summit
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TECNIMEDE

Portugal
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Vortioxetine

Dosage : Film Coated Tablet

Dosage Strength : 15MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Portugal

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09

Peptide Therapy Summit
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Vortioxetine Hydrobromide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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Peptide Therapy Summit
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Vortioxetine Hydrobromide

Dosage : Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Peptide Therapy Summit
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Vortioxetine Hydrobromide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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Peptide Therapy Summit
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Vortioxetine Hydrobromide

Dosage : Tablet

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 204447

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DOSAGE - TABLET;ORAL - EQ 15MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 204447

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DOSAGE - TABLET;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 204447

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DOSAGE - TABLET;ORAL - EQ 5MG BASE

USFDA APPLICATION NUMBER - 204447

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01

Brand Name : Brintellix

Denmark
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Denmark
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Vortioxetine Hydrobromide

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 39.908

Published in :

Country : Norway

RX/OTC/DISCN :

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02

Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 127.83

Published in :

Country : Norway

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Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 15 mg

Price Per Pack (Euro) : 52.217

Published in :

Country : Norway

RX/OTC/DISCN :

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Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 20 mg

Price Per Pack (Euro) : 201.69

Published in :

Country : Norway

RX/OTC/DISCN :

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Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Price Per Pack (Euro) : 21.835

Published in :

Country : Norway

RX/OTC/DISCN :

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06

Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

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Vortioxetine Hydrobromide

Dosage Form : Filmtabl

Dosage Strength : 5mg

Price Per Pack (Euro) : 21.86

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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07

Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Filmtable

Dosage Strength : 10mg

Price Per Pack (Euro) : 37.42

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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08

Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Filmtable

Dosage Strength : 10mg

Price Per Pack (Euro) : 130.12

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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09

Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Filmtable

Dosage Strength : 20mg

Price Per Pack (Euro) : 63.28

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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10

Brand Name : Brintellix

Denmark
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Brand Name : Brintellix

Denmark
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Vortioxetine Hydrobromide

Dosage Form : Filmtable

Dosage Strength : 20mg

Price Per Pack (Euro) : 219.24

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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ABOUT THIS PAGE

Looking for 960203-27-4 / Vortioxetine Hydrobromide API manufacturers, exporters & distributors?

Vortioxetine Hydrobromide manufacturers, exporters & distributors 1

57

PharmaCompass offers a list of Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide manufacturer or Vortioxetine Hydrobromide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vortioxetine Hydrobromide manufacturer or Vortioxetine Hydrobromide supplier.

PharmaCompass also assists you with knowing the Vortioxetine Hydrobromide API Price utilized in the formulation of products. Vortioxetine Hydrobromide API Price is not always fixed or binding as the Vortioxetine Hydrobromide Price is obtained through a variety of data sources. The Vortioxetine Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vortioxetine Hydrobromide

Synonyms

960203-27-4, Vortioxetine hbr, Brintellix, Vortioxetine (lu aa21004) hbr, Trintellix, Vortioxetine (hydrobromide)

Cas Number

960203-27-4

Unique Ingredient Identifier (UNII)

TKS641KOAY

About Vortioxetine Hydrobromide

A piperazine derivative that acts as a serotonin reuptake inhibitor, as a 5-HT3 receptor antagonist, and 5-HT1A receptor agonist. It is used for the treatment of anxiety and depression.

TRINTELLIX Manufacturers

A TRINTELLIX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRINTELLIX, including repackagers and relabelers. The FDA regulates TRINTELLIX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRINTELLIX 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 TRINTELLIX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

TRINTELLIX Suppliers

A TRINTELLIX supplier is an individual or a company that provides TRINTELLIX active pharmaceutical ingredient (API) or TRINTELLIX finished formulations upon request. The TRINTELLIX suppliers may include TRINTELLIX API manufacturers, exporters, distributors and traders.

click here to find a list of TRINTELLIX suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

TRINTELLIX USDMF

A TRINTELLIX DMF (Drug Master File) is a document detailing the whole manufacturing process of TRINTELLIX active pharmaceutical ingredient (API) in detail. Different forms of TRINTELLIX DMFs exist exist since differing nations have different regulations, such as TRINTELLIX USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A TRINTELLIX DMF submitted to regulatory agencies in the US is known as a USDMF. TRINTELLIX USDMF includes data on TRINTELLIX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRINTELLIX USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of TRINTELLIX suppliers with USDMF on PharmaCompass.

TRINTELLIX JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The TRINTELLIX Drug Master File in Japan (TRINTELLIX JDMF) empowers TRINTELLIX API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the TRINTELLIX JDMF during the approval evaluation for pharmaceutical products. At the time of TRINTELLIX JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of TRINTELLIX suppliers with JDMF on PharmaCompass.

TRINTELLIX KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a TRINTELLIX Drug Master File in Korea (TRINTELLIX KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TRINTELLIX. The MFDS reviews the TRINTELLIX KDMF as part of the drug registration process and uses the information provided in the TRINTELLIX KDMF to evaluate the safety and efficacy of the drug.

After submitting a TRINTELLIX 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 TRINTELLIX API can apply through the Korea Drug Master File (KDMF).

click here to find a list of TRINTELLIX suppliers with KDMF on PharmaCompass.

TRINTELLIX WC

A TRINTELLIX written confirmation (TRINTELLIX WC) is an official document issued by a regulatory agency to a TRINTELLIX manufacturer, verifying that the manufacturing facility of a TRINTELLIX active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TRINTELLIX APIs or TRINTELLIX finished pharmaceutical products to another nation, regulatory agencies frequently require a TRINTELLIX WC (written confirmation) as part of the regulatory process.

click here to find a list of TRINTELLIX suppliers with Written Confirmation (WC) on PharmaCompass.

TRINTELLIX 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 TRINTELLIX as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for TRINTELLIX 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 TRINTELLIX 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 TRINTELLIX and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRINTELLIX NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of TRINTELLIX suppliers with NDC on PharmaCompass.

TRINTELLIX GMP

TRINTELLIX 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 TRINTELLIX 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 TRINTELLIX GMP manufacturer or TRINTELLIX GMP API supplier for your needs.

TRINTELLIX CoA

A TRINTELLIX CoA (Certificate of Analysis) is a formal document that attests to TRINTELLIX's compliance with TRINTELLIX specifications and serves as a tool for batch-level quality control.

TRINTELLIX CoA mostly includes findings from lab analyses of a specific batch. For each TRINTELLIX 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.

TRINTELLIX may be tested according to a variety of international standards, such as European Pharmacopoeia (TRINTELLIX EP), TRINTELLIX JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRINTELLIX 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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