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Vortioxetine Hydrobromide

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

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 24 USDMF, 3 JDMF, 5 EU WC, 9 KDMF, 8 NDC API, 30 Listed Suppliers, $ API Reference Price

45 API Suppliers
24 USDMF
3 JDMF
5 EU WC
9 KDMF
8 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

70 FDF Dossiers, 18 FDA Orange Book, 30 Europe, 3 Canada, 6 South Africa, 13 Listed Dossiers

70 FDF Dossiers
18 FDA Orange Book
30 Europe
3 Canada
6 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- EQ 10MG BASE, TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE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TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Faran Shimi Pharmaceutical, 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, 12 Co-Processed Excipients, 11 Lubricants & Glidants, 11 Chewable & Orodispersible Aids, 11 Taste Masking, 9 Granulation, 8 Coating Systems & Additives, 5 Parenteral, 4 Controlled & Modified Release, 4 Film Formers & Plasticizers, 2 Coloring Agents, 2 Rheology Modifiers, 2 Topical, 1 Emulsifying Agents, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 44 NEWS #PharmaBuzz

media
5 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

8 Others

otherSolutions
8 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 3,511

MARKET PLACE

API

FDF

9INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

5DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

366,780,643

Annual Reports (USD Million)

7,952

Finished Drug Prices

93 RELATED EXCIPIENT COMPANIES

170EXCIPIENTS 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

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

01

Metrochem API Private Limited

India

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

Duphat

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Contact Supplier

India

Virtual Booth

Digital Content

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

02

LGM Pharma

U.S.A

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

Duphat

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

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

Product Web Link

03

HRV Global Life Sciences

India

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

Duphat

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

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

AUDIT

04

Nortec Quimica

Brazil

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

Duphat

Not Confirmed

Nortec Quimica is the largest API manufacturer in Latin America.

Contact Supplier

Brazil

Virtual Booth

Digital Content

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

05

Shandong Loncom Pharmaceutical

China

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

Duphat

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Contact Supplier

China

Virtual Booth

Digital Content

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

Shandong Loncom Pharmaceutical company banner

06

Raks Pharma

India

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

Duphat

Not Confirmed

07

Beijing Hope Pharmaceutical

China

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

Duphat

Not Confirmed

08

Beijing Hope Pharmaceutical

China

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

Duphat

Not Confirmed

09

Seasons Biotechnology

China

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

Duphat

Not Confirmed

10

Piramal Pharma Solutions

U.S.A

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

Duphat

Not Confirmed

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Not Confirmed

09

Raks Pharma Pvt Ltd

India

Pharma, Lab & Chemical Expo

Not Confirmed

10

Unichem Laboratories Ltd

India

Pharma, Lab & Chemical Expo

Not Confirmed

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API Reference Price

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ROAD,"},{"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":"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

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

DOSAGE - TABLET;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 204447

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ABOUT THIS PAGE

Vortioxetine Hydrobromide Manufacturers

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

Vortioxetine Hydrobromide Suppliers

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

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

Vortioxetine Hydrobromide USDMF

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

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

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

Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide Drug Master File in Japan (Vortioxetine Hydrobromide JDMF) empowers Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide suppliers with JDMF on PharmaCompass.

Vortioxetine Hydrobromide KDMF

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

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

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

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

Vortioxetine Hydrobromide WC

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

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

Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Vortioxetine Hydrobromide GMP

Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide GMP manufacturer or Vortioxetine Hydrobromide GMP API supplier for your needs.

Vortioxetine Hydrobromide CoA

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

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

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

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1 US Medicaid Prescriptions

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