List of Suppliers' Controlled Modified Release Excipients Application used in Vortioxetine on PharmaCompass.com

Vortioxetine

Megafine Pharma Vortioxetine Hydrobromide RMU

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Metrochem Vortioxetine Hydrobromide

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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
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 23 USDMF, 3 JDMF, 5 EU WC, 8 KDMF, 8 NDC API, 32 Listed Suppliers, $ API Reference Price

45 API Suppliers
23 USDMF
3 JDMF
5 EU WC
8 KDMF
8 NDC API
32 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

79 FDF Dossiers, 18 FDA Orange Book, 30 Europe, 3 Canada, 15 South Africa, 13 Listed Dossiers

79 FDF Dossiers
18 FDA Orange Book
30 Europe
3 Canada
15 South Africa
13 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE

drugProductComposition
TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE
TABLET;ORAL - EQ 5MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 2 DKSH, 7 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 Clariant, 3 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 5 Kerry, 9 Microlex e.U, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 14 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

37 Fillers, Diluents & Binders, 22 Direct Compression, 14 Disintegrants & Superdisintegrants, 13 Thickeners and Stabilizers, 11 Taste Masking, 11 Lubricants & Glidants, 11 Chewable & Orodispersible Aids, 11 Co-Processed Excipients, 9 Granulation, 8 Coating Systems & Additives, 5 Parenteral, 4 Film Formers & Plasticizers, 4 Controlled & Modified Release, 2 Topical, 2 Coloring Agents, 2 Rheology Modifiers, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Emulsifying Agents

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 44 NEWS #PharmaBuzz

media
4 DATA COMPILATION #PharmaFlow
44 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 25 Finished Drug Prices, 17 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
25 Finished Drug Prices
17 Annual Reports

MARKET PLACE

8 APIs, 4 FDF Dossiers, 1 Intermediates

marketPlace
8 APIs
4 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

80 US Patents, 12 US Exclusivities, 12 Health Canada Patents

patents
80 US Patents
12 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 Others

otherSolutions
7 Others

Megafine Pharma Vortioxetine Hydrobromide Popup

Synopsis

ACTIVE PHARMA INGREDIENTS

45

API Suppliers

23

USDMF

0

CEP/COS

CEP/COS Certifications

3

JDMF

5

EU WC

8

KDMF

8

NDC API

0

VMF

32

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 3,500

MARKET PLACE

8

API

4

FDF

9INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

79

FDF Dossiers

18

FDA Orange Book

FDA (Orange Book)

30

Europe

3

Canada

0

Australia

15

South Africa

13

Listed Dossiers

5DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

7

Others

PATENTS & EXCLUSIVITIES

80

US Patents

12

US Exclusivities

12

Health Canada Patents

DIGITAL CONTENT

4

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

44

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

366,780,643

Annual Reports (USD Million)

7,952

Finished Drug Prices

91 RELATED EXCIPIENT COMPANIES

169EXCIPIENTS BY APPLICATIONS

Chemistry

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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 Formula	C₁₈H₂₃BrN₂S
Molecular Weight	379.4 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	378.07653 g/mol
Monoisotopic Mass	378.07653 g/mol
Topological Polar Surface Area	40.6 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	316
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 Information

1 of 2
Drug Name	Brintellix
PubMed Health	Meclizine, Buclizine, and Cyclizine (Oral route, Parenteral route)
Drug Label	BRINTELLIX 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 Ingredient	Vortioxetine hydrobromide
Dosage Form	Tablet
Route	Oral
Strength	eq 15mg base; eq 5mg base; eq 20mg base; eq 10mg base
Market Status	Prescription
Company	Takeda Pharms Usa

2 of 2
Drug Name	Brintellix
PubMed Health	Meclizine, Buclizine, and Cyclizine (Oral route, Parenteral route)
Drug Label	BRINTELLIX 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 Ingredient	Vortioxetine hydrobromide
Dosage Form	Tablet
Route	Oral
Strength	eq 15mg base; eq 5mg base; eq 20mg base; eq 10mg base
Market Status	Prescription
Company	Takeda 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

API SUPPLIERS

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USDMF

01

Alembic Pharmaceuticals Ltd

India

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Not Confirmed

02

Alp Pharm Beijing Co Ltd

China

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Not Confirmed

03

Cipla Ltd

India

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Not Confirmed

04

H Lundbeck As

Denmark

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Not Confirmed

05

Lek Pharmaceuticals Dd

Slovenia

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Not Confirmed

06

Lupin Ltd

India

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Not Confirmed

07

Msn Pharmachem Private Ltd

India

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Not Confirmed

08

Msn Pharmachem Private Ltd

India

Formnext Forum

Not Confirmed

09

Raks Pharma Pvt Ltd

India

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Not Confirmed

10

Unichem Laboratories Ltd

India

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Not Confirmed

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JDMF

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EU WC

01

Megafine Pharma (P) Limited

India

CPhI Worldwide, Milan

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

Contact Supplier

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India

Digital Content

Vortioxetine Hydrobromide IHS

Date of Issue : 2023-08-28

Valid Till : 2025-07-21

Written Confirmation Number : WC-0087-(Annexure-2)

Address of the Firm : Plot No.1 to 5, 31 to 35 & 48 to 51, 26 & K/201, Village Lakhmapur, Taluka Dindo...

Megafine Pharma

Product Web Link

Digital Content

Corporate PDF

02

Alembic Pharmaceuticals Limited

India

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Not Confirmed

03

Cipla

India

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Not Confirmed

04

Cipla

India

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05

MSN Laboratories

India

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Not Confirmed

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Listed Suppliers

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API Reference Price

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ROAD,"},{"dataSource":"API Import","activeIngredients":"VORTIOXETINE HYDROBROMIDE","year":"2021","qtr":"Q2","strtotime":1620757800,"product":"VORTIOXETINE HYDROBROMIDE API","address":"20TH K M, HOSUR ROAD,ELECTRONIC CITY P.O,","city":"BANGALORE","supplier":"BIOBETTA LIMITED","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"BIOCON","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"5966.7","totalValueFC":"1826.7","currency":"USD","unitRateINR":"446008.3","date":"12-May-2021","totalValueINR":"133802.5","totalValueInUsd":"1826.7","indian_port":"BANGALORE AIR","hs_no":"29420090","bill_no":"3922536","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"","customerAddress":"20TH K M, HOSUR ROAD,ELECTRONIC CITY P.O,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695407400,"product":"VORTIOXETINE HYDROBROMIDE IH BATCH NOS:VH21120006(EXP VIDE SB NO:2221363 DT:18-06-22,EXP INV NO:SI3622222120\/16-06-2022)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HIKMA PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"3.80","actualQuantity":"3.8","unit":"KGS","unitRateFc":"4500","totalValueFC":"17977.3","currency":"USD","unitRateINR":"392701.7","date":"23-Sep-2023","totalValueINR":"1492266.49","totalValueInUsd":"17977.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7965038","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMMAN","supplierAddress":"P.O.BOX:182400 INDUSTRIAL AREABAYADER WADI EI-SEER AMMAN11118 JO","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695407400,"product":"VORTIOXETINE HYDROBROMIDE IH BATCH NOS:VH22100003(EXP VIDE SB NO:6743485 DT:06-01-23,EXP INV NO:SI3622226829\/17-12-2022)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HIKMA PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"4.90","actualQuantity":"4.9","unit":"KGS","unitRateFc":"4500","totalValueFC":"23181.3","currency":"USD","unitRateINR":"392701.7","date":"23-Sep-2023","totalValueINR":"1924238.36","totalValueInUsd":"23181.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7965038","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMMAN","supplierAddress":"P.O.BOX:182400 INDUSTRIAL AREABAYADER WADI EI-SEER AMMAN11118 JO","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"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,"}]

Number of Transactions

Total Quantity (KGS)

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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DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 204447

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