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Also known as: 913611-97-9, Opc-34712, Rexulti, 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one, Opc 34712, 2j3ybm1k8c
Molecular Formula
C25H27N3O2S
Molecular Weight
433.6  g/mol
InChI Key
ZKIAIYBUSXZPLP-UHFFFAOYSA-N
FDA UNII
2J3YBM1K8C

Brexpiprazole
Brexpiprazole is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM), and a potent antagonist of serotonin 2A receptors, noradrenergic alpha 1B and 2C receptors. Brexpiprazole is approved for the treatment of schizophrenia, and as an adjunctive treatment for major depressive disorder (MDD). Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).
Brexpiprazole is an Atypical Antipsychotic.
1 2D Structure

Brexpiprazole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
7-[4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy]-1H-quinolin-2-one
2.1.2 InChI
InChI=1S/C25H27N3O2S/c29-25-9-7-19-6-8-20(18-22(19)26-25)30-16-2-1-11-27-12-14-28(15-13-27)23-4-3-5-24-21(23)10-17-31-24/h3-10,17-18H,1-2,11-16H2,(H,26,29)
2.1.3 InChI Key
ZKIAIYBUSXZPLP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CN(CCN1CCCCOC2=CC3=C(C=C2)C=CC(=O)N3)C4=C5C=CSC5=CC=C4
2.2 Other Identifiers
2.2.1 UNII
2J3YBM1K8C
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 7-(4-(4-(1-benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one

2. Rexulti

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2007-01-03
3 Chemical and Physical Properties
Molecular Weight 433.6 g/mol
Molecular Formula C25H27N3O2S
XLogP34.7
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count7
Exact Mass433.18239829 g/mol
Monoisotopic Mass433.18239829 g/mol
Topological Polar Surface Area73 Ų
Heavy Atom Count31
Formal Charge0
Complexity636
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

As an adjunctive treatment of major depressive disorder (MDD) and for treatment of schizophrenia.


FDA Label


Treatment of schizophrenia.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
BREXPIPRAZOLE
5.2.2 FDA UNII
2J3YBM1K8C
5.2.3 Pharmacological Classes
Atypical Antipsychotic [EPC]
5.3 ATC Code

N05AX16


N - Nervous system

N05 - Psycholeptics

N05A - Antipsychotics

N05AX - Other antipsychotics

N05AX16 - Brexpiprazole


5.4 Absorption, Distribution and Excretion

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


5.5 Metabolism/Metabolites

Metabolized mainly by CYP3A4 and CYP2D6 enzymes into its major metabolite, DM-3411. DM-3411 is not considered to contribute any therapeutic effect.


5.6 Biological Half-Life

Brexpiprazole and its major metabolite, DM-3411 have half lives of 91 and 96 hours respectively.


5.7 Mechanism of Action

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.


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Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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DMF Review : N/A

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DMF Number : 32347

Submission : 2017-12-21

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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DMF Review : Complete

Rev. Date : 2019-04-16

Pay. Date : 2019-03-22

DMF Number : 33704

Submission : 2019-03-20

Status : Active

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Tapi Nl Bv

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DMF Review : Complete

Rev. Date : 2019-03-18

Pay. Date : 2018-10-01

DMF Number : 33450

Submission : 2019-02-12

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Rev. Date : 2018-07-10

Pay. Date : 2018-03-27

DMF Number : 32532

Submission : 2018-06-04

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Jubilant Pharmova Ltd

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Lupin Ltd

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Lupin Ltd

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DMF Review : Complete

Rev. Date : 2019-05-02

Pay. Date : 2019-02-07

DMF Number : 33421

Submission : 2019-02-07

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Brexpiprazole IH

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...

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Brexpiprazole IH

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...

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Brexpiprazole IH

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...

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Honour Lab

India
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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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brexpiprazole

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, ...

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Polpharma

Poland
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Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Brexpiprazole

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...

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 development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.
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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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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...

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-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
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LGM Pharma

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

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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, ...

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, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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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...

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 groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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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...

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 offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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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...

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, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Honour Lab

India
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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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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...

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 Synthesis and Honour Specialty, we embrace the science of partnership and possibilities. Our 2500+ team delivers excellence to our pharmaceutical and biotechnology partners through practical solutions. Our commitment to transforming everyday life expands to specialty ingredients for electronics and pharma. Upholding top Environmental, Social, and Governance standards, we collaborate with stakeholders for sustainable, people-centric, transformative outcomes.
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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...

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, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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Brexpiprazole

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...

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 markets of USA, Europe, Russia, Canada and also for non-regulated markets. The first Morepen manufacturing plant was set up on the foothills of the Himalayas in the idyllic surroundings of Parwanoo. The large and spread-out facility is USDFA approved for manufacture of Loratadine, an anti-allergy drug- internationally known as Claritin.
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Brexpiprazole

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...

Nakoda Chemicals Ltd incorporated in 1989 is engaged in manufacturing, developing and marketing of Bulk API'S (Bulk Active Pharma Ingredients), Intermediates, Specialty chemicals and custom synthesis products. At Nakoda, the key strength lies in our policy to achieve highest standard of quality at competitive price and with committed delivery schedules.Nakoda has DMF's and technical dossiers ready for most of its API's and have European "Certificate of suitability" for "Acetazolamide"-a dieuretic drug.
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INCHEON INT\\'","customer":"KUKJEON PHARMACEUTICAL CO LTD","customerCountry":"KOREA, REPUBLIC OF","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"25000","totalValueFC":"2402.8","currency":"USD","unitRateINR":2015412,"date":"09-Aug-2024","totalValueINR":"201541.2","totalValueInUsd":"2402.8","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"3086195","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724092200,"product":"ORGANIC CHEMICAL (INV NO: PI\/3042100365DT. 27.07.2024) BREXPIPRAZOLE ANHYDROUSIH","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"AS PER INVOICE","customerCountry":"BRAZIL","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"18500","totalValueFC":"36656.6","currency":"USD","unitRateINR":1537350,"date":"20-Aug-2024","totalValueINR":"3074700","totalValueInUsd":"36656.6","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3345239","productDescription":"API","marketType":"","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS ? 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25-Jan-2022
06-Mar-2025
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INTERMEDIATE SUPPLIERS

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01

IOPC
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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...

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02

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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03

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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04

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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05

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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06

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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07

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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08

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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09

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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...

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10

IOPC
Not Confirmed
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IOPC
Not Confirmed
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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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 0.25MG

USFDA APPLICATION NUMBER - 205422

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DOSAGE - TABLET;ORAL - 0.5MG

USFDA APPLICATION NUMBER - 205422

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DOSAGE - TABLET;ORAL - 1MG

USFDA APPLICATION NUMBER - 205422

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DOSAGE - TABLET;ORAL - 2MG

USFDA APPLICATION NUMBER - 205422

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DOSAGE - TABLET;ORAL - 3MG

USFDA APPLICATION NUMBER - 205422

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DOSAGE - TABLET;ORAL - 4MG

USFDA APPLICATION NUMBER - 205422

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Patents & EXCLUSIVITIES

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US Patents

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01

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IOPC
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OTSUKA

Japan
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BREXPIPRAZOLE

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

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IOPC
Not Confirmed

OTSUKA

Japan
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IOPC
Not Confirmed

BREXPIPRAZOLE

US Patent Number : 10307419

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 205422

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-12

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IOPC
Not Confirmed

OTSUKA

Japan
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IOPC
Not Confirmed

BREXPIPRAZOLE

US Patent Number : 9839637

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 205422

Patent Use Code : U-543

Delist Requested :

Patent Use Description : TREATMENT OF SCHIZOPHR...

Patent Expiration Date : 2026-04-12

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Not Confirmed

OTSUKA

Japan
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Not Confirmed

BREXPIPRAZOLE

US Patent Number : 8349840

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 205422

Patent Use Code : U-1529

Delist Requested :

Patent Use Description : ADJUNCTIVE TREATMENT O...

Patent Expiration Date : 2026-04-12

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IOPC
Not Confirmed

OTSUKA

Japan
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IOPC
Not Confirmed

BREXPIPRAZOLE

US Patent Number : 9839637

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 205422

Patent Use Code : U-543

Delist Requested :

Patent Use Description : TREATMENT OF SCHIZOPHR...

Patent Expiration Date : 2026-04-12

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IOPC
Not Confirmed

OTSUKA

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BREXPIPRAZOLE

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

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IOPC
Not Confirmed

OTSUKA

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IOPC
Not Confirmed

BREXPIPRAZOLE

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

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IOPC
Not Confirmed

OTSUKA

Japan
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IOPC
Not Confirmed

BREXPIPRAZOLE

US Patent Number : 7888362

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 205422

Patent Use Code :

Delist Requested : Y

Patent Use Description :

Patent Expiration Date : 2026-04-12

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Not Confirmed

OTSUKA

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Not Confirmed

BREXPIPRAZOLE

US Patent Number : RE48059

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 205422

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-12-23

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OTSUKA

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BREXPIPRAZOLE

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

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ABOUT THIS PAGE

Looking for 913611-97-9 / Brexpiprazole API manufacturers, exporters & distributors?

Brexpiprazole manufacturers, exporters & distributors 1

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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.

API | Excipient name

Brexpiprazole

Synonyms

913611-97-9, Opc-34712, Rexulti, 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one, Opc 34712, 2j3ybm1k8c

Cas Number

913611-97-9

Unique Ingredient Identifier (UNII)

2J3YBM1K8C

About Brexpiprazole

Brexpiprazole is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM), and a potent antagonist of serotonin 2A receptors, noradrenergic alpha 1B and 2C receptors. Brexpiprazole is approved for the treatment of schizophrenia, and as an adjunctive treatment for major depressive disorder (MDD). Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).

Brexpiprazole Manufacturers

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.

Brexpiprazole Suppliers

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.

Brexpiprazole USDMF

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.

Brexpiprazole KDMF

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.

Brexpiprazole WC

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.

Brexpiprazole 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 Brexpiprazole as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Brexpiprazole 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 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.

Compounded drug products

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 GMP

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.

Brexpiprazole CoA

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).

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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