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1. 7-(4-(4-(1-benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one
2. Rexulti
1. 913611-97-9
2. Opc-34712
3. Rexulti
4. 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one
5. Opc 34712
6. 2j3ybm1k8c
7. 7-(4-(4-(1-benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one
8. 7-[4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy]-1h-quinolin-2-one
9. Brexpiprazole [usan]
10. Unii-2j3ybm1k8c
11. Brexpiprazole [usan:inn]
12. Rxulti
13. Rexulti (tn)
14. Brexpiprazole.2h2o
15. Brexpiprazole-[d8]
16. Brexpiprazole [mi]
17. Brexpiprazole [inn]
18. Brexpiprazole [jan]
19. Brexpiprazole(opc34712)
20. Brexpiprazole; Opc-34712
21. Brexpiprazole [who-dd]
22. Gtpl7672
23. Schembl1037592
24. Brexpiprazole (jan/usan/inn)
25. Chembl2105760
26. Schembl14772509
27. Amy6914
28. Dtxsid40238527
29. Chebi:134716
30. Hms3885p12
31. Brexpiprazole [orange Book]
32. Bcp10218
33. Bcp24077
34. Ex-a2639
35. Opc34712
36. Mfcd27987920
37. S4639
38. Zinc84758479
39. Akos025291100
40. Akos037515802
41. Ccg-269055
42. Db09128
43. Sb16735
44. Ncgc00378574-01
45. Ncgc00378574-02
46. Ac-30404
47. As-56467
48. Da-35913
49. Hy-15780
50. Ft-0712292
51. A13527
52. D10309
53. Q2924764
54. 2(1h)-quinolinone, 7-(4-(4-benzo(b)thien-4-yl-1-piperazinyl)butoxy)-
55. 7-[4-(4-benzo[b]thien-4-yl-1-piperazinyl)butoxy]- 2(1h)-quinolinone
56. 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1h-quinolin-2-one
57. 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1h-quinolin-2-one
58. 7-[4-(4-benzo[b]thiophen-4-ylpiperazin-1-yl)butoxy]-1h-quinolin-2-one
Molecular Weight | 433.6 g/mol |
---|---|
Molecular Formula | C25H27N3O2S |
XLogP3 | 4.7 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 7 |
Exact Mass | 433.18239829 g/mol |
Monoisotopic Mass | 433.18239829 g/mol |
Topological Polar Surface Area | 73 Ų |
Heavy Atom Count | 31 |
Formal Charge | 0 |
Complexity | 636 |
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 | 1 |
As an adjunctive treatment of major depressive disorder (MDD) and for treatment of schizophrenia.
FDA Label
Treatment of schizophrenia.
Dopamine Agonists
Drugs that bind to and activate dopamine receptors. (See all compounds classified as Dopamine Agonists.)
Serotonin Agents
Drugs used for their effects on serotonergic systems. Among these are drugs that affect serotonin receptors, the life cycle of serotonin, and the survival of serotonergic neurons. (See all compounds classified as Serotonin Agents.)
N05AX16
N - Nervous system
N05 - Psycholeptics
N05A - Antipsychotics
N05AX - Other antipsychotics
N05AX16 - Brexpiprazole
Absorption
Brexpiprazole reaches peak plasma concentration within 4 hours of administration, and steady state occurs within 10-12 days of dosing. Oral bioavailability is 95%, and can be administered with or without food.
Route of Elimination
Approximately 25% urinary and 46% fecal excretion. <1% and ~14% of the unchanged drug was recovered in the urine and feces, respectively.
Volume of Distribution
Intravenous volume of distribution is 1.56L/kg.
Clearance
19.8mL/h/kg
Metabolized mainly by CYP3A4 and CYP2D6 enzymes into its major metabolite, DM-3411. DM-3411 is not considered to contribute any therapeutic effect.
Brexpiprazole and its major metabolite, DM-3411 have half lives of 91 and 96 hours respectively.
Although the mechanism of action of brexpiprazole in the treatment of MDD and schizophrenia is unclear, the efficacy of brexpiprazole may be attributed to partial agonist activity at serotonin 1A and dopamine D2 receptors, and antagonist activity at serotonin 2A receptors.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32347
Submission : 2017-12-21
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-16
Pay. Date : 2019-03-22
DMF Number : 33704
Submission : 2019-03-20
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-18
Pay. Date : 2018-10-01
DMF Number : 33450
Submission : 2019-02-12
Status : Active
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-10
Pay. Date : 2018-03-27
DMF Number : 32532
Submission : 2018-06-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-07
Pay. Date : 2019-04-15
DMF Number : 33122
Submission : 2018-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32995
Submission : 2018-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-02
Pay. Date : 2019-02-07
DMF Number : 33421
Submission : 2019-02-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2019-01-28
DMF Number : 32142
Submission : 2017-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33231
Submission : 2018-10-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-27
Pay. Date : 2018-12-20
DMF Number : 33437
Submission : 2019-01-02
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-02-07
Written Confirmation Number : WC-0082
Address of the Firm : Karakhadi Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist - Vadodara 391 450...
Date of Issue : 2022-08-08
Valid Till : 2025-08-08
Written Confirmation Number : WC-0383
Address of the Firm : Unit-ll, Sy No * Parts of 454,455,457,458 & 459 Chandampet-Village, Shankarampet...
Date of Issue : 2023-11-15
Valid Till : 2026-05-11
Written Confirmation Number : WC-0273
Address of the Firm : Plot No: 34A, Road No: 1, Jawaharlal Nehru Pharma City, Thanam Village, Parawada...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2020-11-06
Registration Number : 20201106-211-J-780
Manufacturer Name : Honour Lab Limited (Unit III...
Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapalli Mandal, ...
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and specialty chemicals & ingredients manufacturer with seven facilities set to global standards of safety and quality. With our offerings, Honour S...
About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...
About the Company : Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated mar...
About the Company : Nakoda Chemicals Ltd incorporated in 1989 is engaged in manufacturing, developing and marketing of Bulk API'S (Bulk Active Pharma Ingredients), Intermediates, Specialty chemicals a...
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7-Hydroxy-3,4-dihydro-1H-quinolin-2-one
CAS Number : 22246-18-0
End Use API : Brexpiprazole
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...
1-(2,3-Dichloro Phenyl) Piperazine HCl
CAS Number : 119532-26-2
End Use API : Brexpiprazole
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...
7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone
CAS Number : 129722-34-5
End Use API : Brexpiprazole
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...
CAS Number : 70500-72-0
End Use API : Brexpiprazole
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
CAS Number : 66490-33-3
End Use API : Brexpiprazole
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
1-(1-BENZOTHIOPHEN-4-YL)PIPERAZINE HCL
CAS Number : 913614-18-3
End Use API : Brexpiprazole
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
1-Benzo[b]thien-4-ylpiperazine monohydrochloride
CAS Number : 913614-18-3
End Use API : Brexpiprazole
About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...
CAS Number : 70500-72-0
End Use API : Brexpiprazole
About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...
7-Hydroxy-3,4-dihydro-2(1H)-Quinolinone
CAS Number : 22246-18-0
End Use API : Brexpiprazole
About The Company : Believe pharma is one of the leading manufacturers of APIs and its intermediates with multi-dimensional business activities. The company maintain a high standa...
CAS Number : 70500-72-0
End Use API : Brexpiprazole
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2033-04-12
US Patent Number : 10307419*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205422
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-04-12
Patent Expiration Date : 2026-10-12
US Patent Number : 8349840*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205422
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-10-12
Patent Expiration Date : 2026-10-12
US Patent Number : 8349840*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205422
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-10-12
Patent Expiration Date : 2026-10-12
US Patent Number : 8618109*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205422
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-10-12
REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Brexpiprazole 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 Brexpiprazole manufacturer or Brexpiprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brexpiprazole manufacturer or Brexpiprazole supplier.
PharmaCompass also assists you with knowing the Brexpiprazole API Price utilized in the formulation of products. Brexpiprazole API Price is not always fixed or binding as the Brexpiprazole Price is obtained through a variety of data sources. The Brexpiprazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Brexpiprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brexpiprazole, including repackagers and relabelers. The FDA regulates Brexpiprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brexpiprazole 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 Brexpiprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brexpiprazole supplier is an individual or a company that provides Brexpiprazole active pharmaceutical ingredient (API) or Brexpiprazole finished formulations upon request. The Brexpiprazole suppliers may include Brexpiprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Brexpiprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brexpiprazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Brexpiprazole active pharmaceutical ingredient (API) in detail. Different forms of Brexpiprazole DMFs exist exist since differing nations have different regulations, such as Brexpiprazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brexpiprazole DMF submitted to regulatory agencies in the US is known as a USDMF. Brexpiprazole USDMF includes data on Brexpiprazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brexpiprazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brexpiprazole suppliers with USDMF 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 Brexpiprazole Drug Master File in Korea (Brexpiprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brexpiprazole. The MFDS reviews the Brexpiprazole KDMF as part of the drug registration process and uses the information provided in the Brexpiprazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brexpiprazole 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 Brexpiprazole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brexpiprazole suppliers with KDMF on PharmaCompass.
A Brexpiprazole written confirmation (Brexpiprazole WC) is an official document issued by a regulatory agency to a Brexpiprazole manufacturer, verifying that the manufacturing facility of a Brexpiprazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Brexpiprazole APIs or Brexpiprazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Brexpiprazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Brexpiprazole 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 Brexpiprazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brexpiprazole 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 Brexpiprazole 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 Brexpiprazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brexpiprazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brexpiprazole suppliers with NDC on PharmaCompass.
Brexpiprazole 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 Brexpiprazole 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 Brexpiprazole GMP manufacturer or Brexpiprazole GMP API supplier for your needs.
A Brexpiprazole CoA (Certificate of Analysis) is a formal document that attests to Brexpiprazole's compliance with Brexpiprazole specifications and serves as a tool for batch-level quality control.
Brexpiprazole CoA mostly includes findings from lab analyses of a specific batch. For each Brexpiprazole 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.
Brexpiprazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Brexpiprazole EP), Brexpiprazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brexpiprazole USP).