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1. 1-(2-(2,4-dimethylphenylsulfanyl)phenyl)piperazine
2. Brintellix
3. Lu Aa21004
4. Lu-aa21004
5. Luaa21004
6. Vortioxetine
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
1. Vortioxetine
| Molecular Weight | 379.4 g/mol |
|---|---|
| Molecular Formula | C18H23BrN2S |
| 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 Ų |
| 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 |
| 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 |
Treatment of major depressive episodes in adults.
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.)
N06AX26
API SUPPLIERS
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USDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41091
Submission : 2024-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-12-27
DMF Number : 31281
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29849
Submission : 2016-08-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-13
Pay. Date : 2017-02-23
DMF Number : 31389
Submission : 2017-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21224
Submission : 2008-01-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-14
Pay. Date : 2017-03-03
DMF Number : 31314
Submission : 2017-03-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-17
Pay. Date : 2017-03-16
DMF Number : 31507
Submission : 2017-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-03
Pay. Date : 2016-09-29
DMF Number : 30309
Submission : 2016-03-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-31
Pay. Date : 2017-05-11
DMF Number : 31411
Submission : 2017-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-24
Pay. Date : 2017-03-27
DMF Number : 31583
Submission : 2017-03-31
Status : Active
Type : II
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RLD :
TE Code :
Brand Name : VORTIOXETINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date :
Application Number : 211101
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : VORTIOXETINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date :
Application Number : 211101
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : VORTIOXETINE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date :
Application Number : 211024
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : VORTIOXETINE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date :
Application Number : 211024
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : VORTIOXETINE
Dosage Form : TABLET;ORAL
Dosage Strength : 15MG
Approval Date :
Application Number : 211024
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : VORTIOXETINE
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date :
Application Number : 211024
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : TRINTELLIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2013-09-30
Application Number : 204447
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TRINTELLIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2013-09-30
Application Number : 204447
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : VORTIOXETINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 5MG BASE
Approval Date :
Application Number : 211146
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : VORTIOXETINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date :
Application Number : 211146
RX/OTC/DISCN :
RLD :
TE Code :
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Regulatory Info :
Registration Country : Norway
Brand Name : Brintellix
Dosage Form : Tablet, film-coated
Dosage Strength : 20 mg
Packaging : Blisterpakning 98item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
vortioxetinhydrobromid, anhydrous
Brand Name : Brintellix
Dosage Form : FILM COATED PILL
Dosage Strength : 20 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
vortioxetinhydrobromid, anhydrous
Brand Name : Brintellix
Dosage Form : FILM COATED PILL
Dosage Strength : 5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Brintellix
Dosage Form : Vortioxetina 10Mg 28 Combined Oral Use
Dosage Strength : 28 cpr riv 10 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Brintellix
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Brintellix
Dosage Form : Tablet, film-coated
Dosage Strength : 5 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Brintellix
Dosage Form : Tablet, film-coated
Dosage Strength : 10 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Brintellix
Dosage Form : Filmtable
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Brintellix
Dosage Form : Filmtable
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Brintellix
Dosage Form : Tropfen
Dosage Strength : 20mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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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
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 204447
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ABOUT THIS PAGE
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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.
A Brintellix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brintellix, including repackagers and relabelers. The FDA regulates Brintellix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brintellix 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 Brintellix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brintellix supplier is an individual or a company that provides Brintellix active pharmaceutical ingredient (API) or Brintellix finished formulations upon request. The Brintellix suppliers may include Brintellix API manufacturers, exporters, distributors and traders.
click here to find a list of Brintellix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brintellix DMF (Drug Master File) is a document detailing the whole manufacturing process of Brintellix active pharmaceutical ingredient (API) in detail. Different forms of Brintellix DMFs exist exist since differing nations have different regulations, such as Brintellix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brintellix DMF submitted to regulatory agencies in the US is known as a USDMF. Brintellix USDMF includes data on Brintellix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brintellix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brintellix suppliers with USDMF on PharmaCompass.
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 Brintellix Drug Master File in Japan (Brintellix JDMF) empowers Brintellix 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 Brintellix JDMF during the approval evaluation for pharmaceutical products. At the time of Brintellix 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 Brintellix suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Brintellix Drug Master File in Korea (Brintellix KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brintellix. The MFDS reviews the Brintellix KDMF as part of the drug registration process and uses the information provided in the Brintellix KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brintellix 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 Brintellix API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brintellix suppliers with KDMF on PharmaCompass.
A Brintellix written confirmation (Brintellix WC) is an official document issued by a regulatory agency to a Brintellix manufacturer, verifying that the manufacturing facility of a Brintellix active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Brintellix APIs or Brintellix finished pharmaceutical products to another nation, regulatory agencies frequently require a Brintellix WC (written confirmation) as part of the regulatory process.
click here to find a list of Brintellix suppliers with Written Confirmation (WC) on PharmaCompass.
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 Brintellix as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brintellix API and other APIs are published in this directory by the FDA.
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 Brintellix 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.
The NDC directory also contains data on finished compounded human drug products that contain Brintellix and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brintellix NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brintellix suppliers with NDC on PharmaCompass.
Brintellix 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 Brintellix 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 Brintellix GMP manufacturer or Brintellix GMP API supplier for your needs.
A Brintellix CoA (Certificate of Analysis) is a formal document that attests to Brintellix's compliance with Brintellix specifications and serves as a tool for batch-level quality control.
Brintellix CoA mostly includes findings from lab analyses of a specific batch. For each Brintellix 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.
Brintellix may be tested according to a variety of international standards, such as European Pharmacopoeia (Brintellix EP), Brintellix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brintellix USP).
