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Also known as: 869113-09-7, Incruse ellipta, Gsk573719a, Umeclidinium (bromide), Anoro ellipta, 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-quinuclidinium bromide
Molecular Formula
C29H34BrNO2
Molecular Weight
508.5  g/mol
InChI Key
PEJHHXHHNGORMP-UHFFFAOYSA-M
FDA UNII
7AN603V4JV

Umeclidinium Bromide
Umeclidinium Bromide is the bromide salt form of umeclidinium, a muscarinic receptor antagonist, with bronchodilator activity. Although it does not display selectivity for specific muscarinic receptors, on topical application, umeclidinium acts mainly on M3 muscarinic receptors located on smooth muscle cells, thereby preventing smooth muscle contraction and resulting in bronchodilatory effect.
1 2D Structure

Umeclidinium Bromide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
diphenyl-[1-(2-phenylmethoxyethyl)-1-azoniabicyclo[2.2.2]octan-4-yl]methanol;bromide
2.1.2 InChI
InChI=1S/C29H34NO2.BrH/c31-29(26-12-6-2-7-13-26,27-14-8-3-9-15-27)28-16-19-30(20-17-28,21-18-28)22-23-32-24-25-10-4-1-5-11-25;/h1-15,31H,16-24H2;1H/q+1;/p-1
2.1.3 InChI Key
PEJHHXHHNGORMP-UHFFFAOYSA-M
2.1.4 Canonical SMILES
C1C[N+]2(CCC1(CC2)C(C3=CC=CC=C3)(C4=CC=CC=C4)O)CCOCC5=CC=CC=C5.[Br-]
2.2 Other Identifiers
2.2.1 UNII
7AN603V4JV
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 869113-09-7

2. Incruse Ellipta

3. Gsk573719a

4. Umeclidinium (bromide)

5. Anoro Ellipta

6. 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-quinuclidinium Bromide

7. Gsk-573719a

8. 7an603v4jv

9. Mfcd27976798

10. 1-(2-(benzyloxy)ethyl)-4-(hydroxydiphenylmethyl)quinuclidin-1-ium Bromide

11. Diphenyl-[1-(2-phenylmethoxyethyl)-1-azoniabicyclo[2.2.2]octan-4-yl]methanol Bromide

12. Chembl523299

13. Diphenyl-[1-(2-phenylmethoxyethyl)-1-azoniabicyclo[2.2.2]octan-4-yl]methanol;bromide

14. Unii-7an603v4jv

15. Umeclidinium Bromide [usan]

16. Umeclidinium Brom

17. Umeclidinium Bromide [usan:inn]

18. Umeclidinii Bromidum

19. 4-[hydroxy(diphenyl)methyl]-1-[2-[(phenylmethyl)oxy]ethyl]-1-azoniabicyclo[2.2.2]octane Bromide

20. 4-[hydroxy(diphenyl)methyl]-1-{2-[(phenylmethyl)oxy]ethyl}-1-azoniabicyclo[2.2.2]octane Bromide

21. Umec

22. Bromure D'umeclidinium

23. Bromuro De Umeclidinio

24. Incruse Ellipta (tn)

25. Schembl109931

26. Chebi:79040

27. Dtxsid50235966

28. Umeclidinium Bromide [mi]

29. Umeclidinium Bromide (jan/usan)

30. Hms3885a04

31. Umeclidinium Bromide [inn]

32. Umeclidinium Bromide [jan]

33. Bcp11148

34. Ex-a1683

35. Umeclidinium Bromide [vandf]

36. Umeclidinium Bromide [who-dd]

37. Akos025404842

38. Ccg-269761

39. Cs-0874

40. Sb16738

41. Ac-30852

42. As-57320

43. Hy-12100

44. Sy226333

45. Umeclidinium Bromide [orange Book]

46. Ft-0775078

47. D10181

48. A916880

49. Q15624035

50. Trelegy Ellipta Component Umeclidinium Bromide

51. Umeclidinium Bromide Component Of Trelegy Ellipta

52. 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-quinuclidiniumbromide

53. 1-(2-(benzyloxy)ethyl)-4-(hydroxydiphenylmethyl)-1-azoniabicyclo(2.2.2)octane Bromide

54. 1-[2-(benzyloxy)ethyl]-4(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane Bromide

55. 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azabicyclo[2.2.2]octan-1-ium Bromide

56. 1-[2-(benzyloxy)ethyl]-4-[hydroxy(diphenyl)methyl]-1-azoniabicyclo[2.2.2]octane Bromide

57. 1-(2-((benzyl)oxy)ethyl)4-(hydroxydi(phenyl)methyl)-1-azabicyclo(2.2.2)octan-1-ium Bromide

58. 1-azoniabicyclo(2.2.2)octane, 4-(hydroxydiphenylmethyl)-1-(2-(phenylmethoxy)ethyl)-, Bromide (1:1)

59. Gsk-573719 Pound>> Gsk573719 Pound>> Gsk 573719 Pound>>gsk573719a;gsk-573719a;gsk 573719a

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 508.5 g/mol
Molecular Formula C29H34BrNO2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count8
Exact Mass507.17729 g/mol
Monoisotopic Mass507.17729 g/mol
Topological Polar Surface Area29.5 Ų
Heavy Atom Count33
Formal Charge0
Complexity543
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameIncruse ellipta
PubMed HealthUmeclidinium (By breathing)
Drug ClassesRespiratory Agent
Active IngredientUmeclidinium bromide
Dosage FormPowder
RouteInhalation
Strengtheq 62.5mcg base/inh
Market StatusPrescription
CompanyGlaxo Grp England

2 of 2  
Drug NameIncruse ellipta
PubMed HealthUmeclidinium (By breathing)
Drug ClassesRespiratory Agent
Active IngredientUmeclidinium bromide
Dosage FormPowder
RouteInhalation
Strengtheq 62.5mcg base/inh
Market StatusPrescription
CompanyGlaxo Grp England

4.2 Drug Indication

Rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).


Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).


5 Pharmacology and Biochemistry
5.1 ATC Code

R03BB07


R03BB07


R03BB07

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03B - Other drugs for obstructive airway diseases, inhalants

R03BB - Anticholinergics

R03BB07 - Umeclidinium bromide


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ABOUT THIS PAGE

Umeclidinium Bromide Manufacturers

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

Umeclidinium Bromide Suppliers

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

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

Umeclidinium Bromide USDMF

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

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

click here to find a list of Umeclidinium Bromide suppliers with USDMF on PharmaCompass.

Umeclidinium Bromide KDMF

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

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

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

click here to find a list of Umeclidinium Bromide suppliers with KDMF on PharmaCompass.

Umeclidinium Bromide 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 Umeclidinium Bromide as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Umeclidinium Bromide suppliers with NDC on PharmaCompass.

Umeclidinium Bromide GMP

Umeclidinium Bromide 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 Umeclidinium Bromide 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 Umeclidinium Bromide GMP manufacturer or Umeclidinium Bromide GMP API supplier for your needs.

Umeclidinium Bromide CoA

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

Umeclidinium Bromide CoA mostly includes findings from lab analyses of a specific batch. For each Umeclidinium Bromide 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.

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