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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
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
Molecular Weight | 508.6 g/mol |
---|---|
Molecular Formula | C28H32N2O7 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 8 |
Exact Mass | 508.22095136 g/mol |
Monoisotopic Mass | 508.22095136 g/mol |
Topological Polar Surface Area | 156 Ų |
Heavy Atom Count | 37 |
Formal Charge | 0 |
Complexity | 708 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Arcapta neohaler |
PubMed Health | Indacaterol (By breathing) |
Drug Classes | Bronchodilator |
Drug Label | ARCAPTA 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 Ingredient | Indacaterol maleate |
Dosage Form | Powder |
Route | Inhalation |
Strength | eq 75mcg base |
Market Status | Prescription |
Company | Novartis |
2 of 2 | |
---|---|
Drug Name | Arcapta neohaler |
PubMed Health | Indacaterol (By breathing) |
Drug Classes | Bronchodilator |
Drug Label | ARCAPTA 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 Ingredient | Indacaterol maleate |
Dosage Form | Powder |
Route | Inhalation |
Strength | eq 75mcg base |
Market Status | Prescription |
Company | Novartis |
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
R03AC18
R03AC18
R03AC18
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info :
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 0.15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 0.15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 0.3mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Indacaterol; Mometasone-17 furoase
Brand Name : Atectura Breezhaler
Dosage Form : Inh Kaps
Dosage Strength : 150mcg/160mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Indacaterol; Mometasone-17 furoase
Brand Name : Atectura Breezhaler
Dosage Form : Inh Kaps
Dosage Strength : 150mcg/160mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Indacaterol; Mometasone-17 furoase
Brand Name : Atectura Breezhaler
Dosage Form : Inh Kaps
Dosage Strength : 150mcg/80mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Indacaterol; Mometasone-17 furoase
Brand Name : Atectura Breezhaler
Dosage Form : Inh Kaps
Dosage Strength : 150mcg/80mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ultibro Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 110mcg/50mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ultibro Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 110mcg/50mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Indacaterolum; Glycopyrronium; Mometasoni-17 furoas
Brand Name : Enerzair Breezhaler Inha
Dosage Form : Inh Caps
Dosage Strength : 150/50/160Mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Onbrez
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Onbrez
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Onbrez
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Onbrez
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Indacaterol; Glycopyrronium Bromide
Brand Name :
Dosage Form : Capsule - Powder for I...
Dosage Strength : 85MCG; 43MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Indacaterol; Glycopyrronium Bromide
Dosage : Capsule - Powder for I...
Dosage Strength : 85MCG; 43MCG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Indacaterol Maleate; Glycopyrronium Bromide
Brand Name :
Dosage Form : Inhalation Powder
Dosage Strength : 85; 43
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Indacaterol Maleate; Glycopyrronium Bromide
Dosage : Inhalation Powder
Dosage Strength : 85; 43
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Global Sales Information
Dosage Form : Inh Caps
Dosage Strength : 0.15mg
Price Per Pack (Euro) : 35.06
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Inh Caps
Dosage Strength : 0.3mg
Price Per Pack (Euro) : 41.12
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Inh Caps
Dosage Strength : 0.15mg
Price Per Pack (Euro) : 89.4
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Inh Caps
Dosage Strength : 0.3mg
Price Per Pack (Euro) : 104.88
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Indacaterol Maleate; Glycopyrronium Bromide
Dosage Form : Inh Caps
Dosage Strength : 110mcg/50mcg
Price Per Pack (Euro) : 45.57
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Indacaterol Maleate; Glycopyrronium Bromide
Dosage Form : Inh Caps
Dosage Strength : 110mcg/50mcg
Price Per Pack (Euro) : 136.55
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Indacaterol Maleate; Glycopyrronium Bromide; Mometasone Furoate
Dosage Form : Inh Caps
Dosage Strength : 150/50/160Mcg
Price Per Pack (Euro) : 63.11
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Indacaterol Maleate; Glycopyrronium Bromide; Mometasone Furoate
Dosage Form : Inh Caps
Dosage Strength : 150/50/160Mcg
Price Per Pack (Euro) : 189.33
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Indacaterol Maleate; Glycopyrronium Bromide; Mometasone Furoate
Dosage Form : Inh Caps
Dosage Strength : 150/50/160Mcg
Price Per Pack (Euro) : 63.11
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Indacaterol Maleate; Mometasone Furoate
Dosage Form : Inh Kaps
Dosage Strength : 150mcg/160mcg
Price Per Pack (Euro) : 32.28
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2028-10-20
GLYCOPYRROLATE; INDACATEROL MALEATE
US Patent Number : 8182838
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 207930
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-20
Patent Expiration Date : 2025-02-25
US Patent Number : 6878721
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 22383
Patent Use Code : U-1168
Delist Requested :
Patent Use Description : THE LONG TERM, ONCE-DA...
Patent Expiration Date : 2025-02-25
Patent Expiration Date : 2025-02-25
GLYCOPYRROLATE; INDACATEROL MALEATE
US Patent Number : 6878721
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 207930
Patent Use Code : U-1773
Delist Requested :
Patent Use Description : LONG - TERM MAINTENANC...
Patent Expiration Date : 2025-02-25
Patent Expiration Date : 2028-10-11
GLYCOPYRROLATE; INDACATEROL MALEATE
US Patent Number : 8479730
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 207930
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-11
Patent Expiration Date : 2025-05-12
Date Granted : 2013-09-24
Brand Name : ONBREZ BREEZHALER
Patent Number : 2563573
Filing Date : 2005-05-12
Strength per Unit : 75 ?g
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Capsule Inhalation
Patent Expiration Date : 2025-05-12
Date Granted : 2013-09-24
Patent Expiration Date : 2020-06-02
Date Granted : 2010-09-07
Brand Name : ONBREZ BREEZHALER
Patent Number : 2375810
Filing Date : 2000-06-02
Strength per Unit : 75 ?g
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Capsule Inhalation
Patent Expiration Date : 2020-06-02
Date Granted : 2010-09-07
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
19
PharmaCompass offers a list of Indacaterol Maleate 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 Indacaterol Maleate manufacturer or Indacaterol Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Indacaterol Maleate manufacturer or Indacaterol Maleate supplier.
PharmaCompass also assists you with knowing the Indacaterol Maleate API Price utilized in the formulation of products. Indacaterol Maleate API Price is not always fixed or binding as the Indacaterol Maleate Price is obtained through a variety of data sources. The Indacaterol Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).