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    Chemistry

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    Also known as: 753498-25-8, Arcapta neohaler, Indacaterol (maleate), Indacterol maleate, Indacaterol maleate [usan], Qab149-afa
    Molecular Formula
    C28H32N2O7
    Molecular Weight
    508.6  g/mol
    InChI Key
    IREJFXIHXRZFER-PCBAQXHCSA-N
    FDA UNII
    2JEC1ITX7R
    Indacaterol Maleate
    1 2D Structure

    Indacaterol Maleate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (Z)-but-2-enedioic acid;5-[(1R)-2-[(5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1H-quinolin-2-one
    2.1.2 InChI
    InChI=1S/C24H28N2O3.C4H4O4/c1-3-14-9-16-11-18(12-17(16)10-15(14)4-2)25-13-22(28)19-5-7-21(27)24-20(19)6-8-23(29)26-24;5-3(6)1-2-4(7)8/h5-10,18,22,25,27-28H,3-4,11-13H2,1-2H3,(H,26,29);1-2H,(H,5,6)(H,7,8)/b;2-1-/t22-;/m0./s1
    2.1.3 InChI Key
    IREJFXIHXRZFER-PCBAQXHCSA-N
    2.1.4 Canonical SMILES
    CCC1=C(C=C2CC(CC2=C1)NCC(C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.C(=CC(=O)O)C(=O)O
    2.1.5 Isomeric SMILES
    CCC1=C(C=C2CC(CC2=C1)NC[C@@H](C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.C(=C\C(=O)O)\C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    2JEC1ITX7R
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-(2-(5,6-diethylindan-2-ylamino)-1-hydroxyethyl)-8-hydroxy-1h-quinolin-2-one

    2. Arcapta Neohaler

    3. Indacaterol

    4. Onbrez

    5. Qab-149

    2.3.2 Depositor-Supplied Synonyms

    1. 753498-25-8

    2. Arcapta Neohaler

    3. Indacaterol (maleate)

    4. Indacterol Maleate

    5. Indacaterol Maleate [usan]

    6. Qab149-afa

    7. Qab-149-afa

    8. Indacaterol (as Maleate)

    9. 2jec1itx7r

    10. Chebi:68573

    11. 753498-25-8 (malate)

    12. Qabi49

    13. (r)-5-(2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl)-8-hydroxyquinolin-2(1h)-one Maleate

    14. Qab-149 Maleate

    15. Unii-2jec1itx7r

    16. Qab 149afa

    17. Oslif Breezhaler

    18. Onbrez Breezhaler

    19. Hirobriz Breezhaler

    20. (r)-5-[2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1h)-one Maleate

    21. Arcapta Neohaler (tn)

    22. Onbrez Inhalation Capsules

    23. Indacaterol Maleic Acid Salt

    24. Schembl523627

    25. Chembl1789842

    26. Indacaterol Maleate [mi]

    27. Indacaterol Maleate (jan/usan)

    28. Indacaterol Maleate [jan]

    29. Hms3885o07

    30. Indacaterol Maleate [mart.]

    31. Hy-14299a

    32. Indacaterol Maleate [who-dd]

    33. Mfcd20526769

    34. Indacaterol Maleate [ema Epar]

    35. Ccg-269764

    36. Indacaterol Maleate [orange Book]

    37. Ac-30121

    38. As-10152

    39. Ultibro Component Indacaterol Maleate

    40. I0927

    41. Qva149 Component Indacaterol Maleate

    42. S3083

    43. Qva-149 Component Indacaterol Maleate

    44. D09319

    45. Indacaterol Maleate Component Of Utibron

    46. Q27137018

    47. (6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)pyrimidin-4-yl)amino)-2,2-dimethyl-3-oxo-2,3-dihydro-4h- Pyrido(3,2-b)-1,4-oxazin-4-yl)methyl Dihydrogen Phosphate

    48. (z)-but-2-enedioic Acid;5-[(1r)-2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1h-quinolin-2-one

    49. 2(1h)-quinolinone, 5-((1r)-2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl )-8-hydroxy-, (2z)-2-butenedioate (1:1)

    50. 2(1h)-quinolinone, 5-((1r)-2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl)-8-hydroxy-, (2z)-2-butenedioate (1:1)

    51. 435273-74-8

    52. 5,6-diethyl-n-[(2r)-2-hydroxy-2-(8-hydroxy-2-oxo-1,2-dihydroquinolin-5-yl)ethyl]indan-2-aminium (2z)-3-carboxyacrylate

    53. 5-((1r)-2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl)-8- Hydroxyquinolin-2(1h)-one Hydrogen (2z)-2-butenedioate (salt)

    54. 5-[(r)-2-(5,6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1h-quinolin-2-one Maleate

    55. 5-{(1r)-2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl}-8-hydroxyquinolin-2(1h)-one (2z)-but-2-enedioate

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 508.6 g/mol
    Molecular Formula C28H32N2O7
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count8
    Exact Mass508.22095136 g/mol
    Monoisotopic Mass508.22095136 g/mol
    Topological Polar Surface Area156 Ų
    Heavy Atom Count37
    Formal Charge0
    Complexity708
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameArcapta neohaler
    PubMed HealthIndacaterol (By breathing)
    Drug ClassesBronchodilator
    Drug LabelARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALERinhaler. The inhalation powder is packaged in clear gelatin capsules.Each clear, hard gelatin capsule contains a dry powder blend...
    Active IngredientIndacaterol maleate
    Dosage FormPowder
    RouteInhalation
    Strengtheq 75mcg base
    Market StatusPrescription
    CompanyNovartis

    2 of 2  
    Drug NameArcapta neohaler
    PubMed HealthIndacaterol (By breathing)
    Drug ClassesBronchodilator
    Drug LabelARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALERinhaler. The inhalation powder is packaged in clear gelatin capsules.Each clear, hard gelatin capsule contains a dry powder blend...
    Active IngredientIndacaterol maleate
    Dosage FormPowder
    RouteInhalation
    Strengtheq 75mcg base
    Market StatusPrescription
    CompanyNovartis

    4.2 Drug Indication

    Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

    Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

    Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

    Chronic obstructive pulmonary disease

    5 Pharmacology and Biochemistry
    5.1 ATC Code

    R03AC18

    R03AC18

    R03AC18

    API Reference Price

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PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.04","actualQuantity":"0.04","unit":"KGS","unitRateFc":"180000","totalValueFC":"7533.3","currency":"EUR","unitRateINR":"14985000","date":"01-Aug-2022","totalValueINR":"599400","totalValueInUsd":"7533.3","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"9821195","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700764200,"product":"INDACATEROL MALEATE API (BATCH NO. P-31M) (INDACATEROL MALEATE MICRONIZED)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.28","actualQuantity":"0.28","unit":"KGS","unitRateFc":"198000","totalValueFC":"61085.2","currency":"EUR","unitRateINR":"18166500","date":"24-Nov-2023","totalValueINR":"5086620","totalValueInUsd":"61085.2","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8910139","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT C\/ARGENT 1 08755 CASTELLBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717698600,"product":"INDACATEROL MALEATE MICRONIZED (BATCH NO. P-33M) (INDACATEROL MALEATE)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"198000","totalValueFC":"5481.9","currency":"EUR","unitRateINR":"18305100","date":"07-Jun-2024","totalValueINR":"457627.5","totalValueInUsd":"5481.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3878310","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT C\/ARGENT 1 08755 CASTELLBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
    18-Jan-2021
    20-Sep-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH

    USFDA APPLICATION NUMBER - 207930

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    DOSAGE - POWDER;INHALATION - EQ 75MCG BASE

    USFDA APPLICATION NUMBER - 22383

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    ABOUT THIS PAGE

    Indacaterol Maleate Manufacturers

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

    Indacaterol Maleate Suppliers

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

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

    Indacaterol Maleate USDMF

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

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

    click here to find a list of Indacaterol Maleate suppliers with USDMF on PharmaCompass.

    Indacaterol Maleate KDMF

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

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

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

    click here to find a list of Indacaterol Maleate suppliers with KDMF on PharmaCompass.

    Indacaterol Maleate WC

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

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

    Indacaterol Maleate 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 Indacaterol Maleate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Indacaterol Maleate suppliers with NDC on PharmaCompass.

    Indacaterol Maleate GMP

    Indacaterol Maleate 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 Indacaterol Maleate 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 Indacaterol Maleate GMP manufacturer or Indacaterol Maleate GMP API supplier for your needs.

    Indacaterol Maleate CoA

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

    Indacaterol Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Indacaterol Maleate 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.

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