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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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P-28M) (INDACATEROL MALEATE MICRONIZED) (FOR R&D PURPOSE ONLY)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.04","actualQuantity":"0.04","unit":"KGS","unitRateFc":"198000","totalValueFC":"8621","currency":"EUR","unitRateINR":"17760600","date":"27-Dec-2022","totalValueINR":"710424","totalValueInUsd":"8621","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"3929469","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":"Q3","strtotime":1690482600,"product":"INDACATEROL MALEATE (BATCH NO. P-30M) (INDACATEROL MALEATE MICRONIZED) (FOR R&D PURPOSE ONLY)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.03","unit":"KGS","unitRateFc":"198000","totalValueFC":"6775.5","currency":"EUR","unitRateINR":"18562500.4","date":"28-Jul-2023","totalValueINR":"556874.661","totalValueInUsd":"6775.5","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"0","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. 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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
19-Dec-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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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

Arcapta neohaler (TN) Manufacturers

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

Arcapta neohaler (TN) Suppliers

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

click here to find a list of Arcapta neohaler (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Arcapta neohaler (TN) USDMF

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

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

click here to find a list of Arcapta neohaler (TN) suppliers with USDMF on PharmaCompass.

Arcapta neohaler (TN) KDMF

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

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

After submitting a Arcapta neohaler (TN) 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 Arcapta neohaler (TN) API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Arcapta neohaler (TN) suppliers with KDMF on PharmaCompass.

Arcapta neohaler (TN) WC

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

click here to find a list of Arcapta neohaler (TN) suppliers with Written Confirmation (WC) on PharmaCompass.

Arcapta neohaler (TN) 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 Arcapta neohaler (TN) as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Arcapta neohaler (TN) suppliers with NDC on PharmaCompass.

Arcapta neohaler (TN) GMP

Arcapta neohaler (TN) 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 Arcapta neohaler (TN) 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 Arcapta neohaler (TN) GMP manufacturer or Arcapta neohaler (TN) GMP API supplier for your needs.

Arcapta neohaler (TN) CoA

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

Arcapta neohaler (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Arcapta neohaler (TN) 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.

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