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    Chemistry

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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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OF","customerCountry":"EGYPT","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4932.7","totalValueFC":"4874.2","currency":"USD","unitRateINR":407440,"date":"05-Jul-2024","totalValueINR":"407440","totalValueInUsd":"4874.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29337990","bill_no":"4000546","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"BREXPIPRAZOLE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ZYDUS LIFESCIENCES LIMITED","supplierCountry":"INDIA","foreign_port":"YANGON","customer":"ALIDAC HEALTHCARE MYANMAR ","customerCountry":"MYANMAR","quantity":"0.81","actualQuantity":"0.805","unit":"KGS","unitRateFc":"7600","totalValueFC":"5989.5","currency":"USD","unitRateINR":621945.09316770185,"date":"11-Jul-2024","totalValueINR":"500665.8","totalValueInUsd":"5989.5","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"2334998","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MYANMAR","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"BREXPIPRAZOLEBXP(PT)188\/RD\/24","address":"PLOT NO.1-A SEC-16A","city":"NOIDA (U.P) INDIA","supplier":"JUBILANT PHARMOVA","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"G2GBIO CO LTD","customerCountry":"REPUBLIC OF KOREA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"20","totalValueFC":"1904.5","currency":"USD","unitRateINR":1591.9749999999999,"date":"12-Jul-2024","totalValueINR":"159197.5","totalValueInUsd":"1904.5","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"2372983","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"PLOT NO.1-A SEC-16A, NOIDA (U.P) INDIA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723141800,"product":"BREXPIPRAZOLE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"GUANGZHOU","customer":"ZHONGHUAN QIKANG(HEFEI)PHARMACEUTIC","customerCountry":"CHINA","quantity":"9.00","actualQuantity":"9","unit":"KGS","unitRateFc":"6200","totalValueFC":"55028.7","currency":"USD","unitRateINR":512858.44444444444,"date":"09-Aug-2024","totalValueINR":"4615726","totalValueInUsd":"55028.7","indian_port":"Vizag-HIPL SEZ","hs_no":"29337990","bill_no":"3096090","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723746600,"product":"BREXPIPRAZOLE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"N\/A","customer":"CMG PHARMACEUTICAL CO., LTD","customerCountry":"REPUBLIC OF KOREA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"24456.1","totalValueFC":"2415.6","currency":"USD","unitRateINR":2026190,"date":"16-Aug-2024","totalValueINR":"202619","totalValueInUsd":"2415.6","indian_port":"Vizag-HIPL SEZ","hs_no":"29337990","bill_no":"3243777","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733769000,"product":"BREXPIPRAZOLE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"EL QAHIRA (= CAIRO)","customer":"N\/A","customerCountry":"EGYPT","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"3882.7","totalValueFC":"19169.5","currency":"USD","unitRateINR":325762,"date":"10-Dec-2024","totalValueINR":"1628810","totalValueInUsd":"19169.5","indian_port":"Vizag-HIPL SEZ","hs_no":"29337990","bill_no":"6312109","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""}]
    19-Jan-2021
    10-Dec-2024
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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 - 4MG

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    ABOUT THIS PAGE

    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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