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Chemistry

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Also known as: Veramyst, Avamys, 397864-44-7, Allermist, Furamist, Arnuity ellipta
Molecular Formula
C27H29F3O6S
Molecular Weight
538.6  g/mol
InChI Key
XTULMSXFIHGYFS-VLSRWLAYSA-N
FDA UNII
JS86977WNV

Fluticasone Furoate
Fluticasone Furoate is the furoate salt form of fluticasone, a synthetic trifluorinated glucocorticoid receptor agonist with anti-allergic, anti-inflammatory and anti-pruritic effects. Upon administration, fluticasone binds to and activates glucocorticoid receptor, resulting in the activation of lipocortin. Lipocortin, in turn, inhibits cytosolic phospholipase A2 and the cascade of reactions involved in the synthesis of inflammatory mediators, such as prostaglandins and leukotrienes. Secondly, mitogen-activated protein kinase (MAPK) phosphatase 1 is induced, which leads to dephosphorylation and inactivation of Jun N-terminal kinase and directly inhibits c-Jun mediated transcription. Finally, transcriptional activity of nuclear factor (NF)-kappa-B is blocked, thereby inhibiting the transcription of cyclooxygenase 2 (COX-2), which is essential for prostaglandin production.
1 2D Structure

Fluticasone Furoate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9-difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate
2.1.2 InChI
InChI=1S/C27H29F3O6S/c1-14-9-16-17-11-19(29)18-10-15(31)6-7-24(18,2)26(17,30)21(32)12-25(16,3)27(14,23(34)37-13-28)36-22(33)20-5-4-8-35-20/h4-8,10,14,16-17,19,21,32H,9,11-13H2,1-3H3/t14-,16+,17+,19+,21+,24+,25+,26+,27+/m1/s1
2.1.3 InChI Key
XTULMSXFIHGYFS-VLSRWLAYSA-N
2.1.4 Canonical SMILES
CC1CC2C3CC(C4=CC(=O)C=CC4(C3(C(CC2(C1(C(=O)SCF)OC(=O)C5=CC=CO5)C)O)F)C)F
2.1.5 Isomeric SMILES
C[C@@H]1C[C@H]2[C@@H]3C[C@@H](C4=CC(=O)C=C[C@@]4([C@]3([C@H](C[C@@]2([C@]1(C(=O)SCF)OC(=O)C5=CC=CO5)C)O)F)C)F
2.2 Other Identifiers
2.2.1 UNII
JS86977WNV
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Veramyst

2. Avamys

3. 397864-44-7

4. Allermist

5. Furamist

6. Arnuity Ellipta

7. Ennhale

8. Gsk 685 698

9. Flonase Sensimist

10. Gw685698x

11. Gsk 685698

12. Gw-685698x

13. Js86977wnv

14. Chebi:74899

15. Gsk685968

16. Gsk-685968

17. Gw 685698x

18. [(6s,8s,9r,10s,11s,13s,14s,16r,17r)-6,9-difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate

19. Alisade

20. (6s,8s,9r,10s,11s,13s,14s,16r,17r)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl Furan-2-carboxylate

21. Unii-js86977wnv

22. Fluticasone Furoate [usan:inn]

23. Fluticasonum Furoas

24. Veramyst (tn)

25. Furoate De Fluticasone

26. Furoato De Fluticasona

27. Fluticasone Furancarboxylate

28. Chembl1676

29. Schembl140504

30. Flonase Sensimist Allergy Relief

31. Fluticasone Furoate [mi]

32. Gtpl10892

33. Fluticasone Furoate [inn]

34. Fluticasone Furoate [jan]

35. Gw685698

36. Dtxsid401024827

37. Fluticasone Furoate [usan]

38. Fluticasone Furoate [vandf]

39. Bcp18136

40. Fluticasone Furoate [mart.]

41. Zinc3992105

42. Bdbm50354851

43. Fluticasone Furoate [who-dd]

44. S6487

45. Fluticasone Furoate (jan/usan/inn)

46. Fluticasone Furoate [ema Epar]

47. Db08906

48. Fluticasone Furoate [orange Book]

49. Hy-15234

50. Avamys Pound>> Veramyst Pound>> Allermist

51. Gw-685698

52. Cs-0003822

53. Drosta-1,4-dien-17-yl Furan-2-carboxylate

54. D06315

55. E86983

56. Breo Ellipta Component Fluticasone Furoate

57. Arnuity Ellipta Component Fluticasone Furoate

58. Fluticasone Furoate Component Of Breo Ellipta

59. Q2166700

60. Trelegy Ellipta Component Fluticasone Furoate

61. Fluticasone Furoate Component Of Arnuity Ellipta

62. Fluticasone Furoate Component Of Trelegy Ellipta

63. (6.alpha.,11.beta.,16.alpha.,17.alpha.)-6,9-difluoro-17-(((fluoro-methyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate

64. (6.alpha.,11.beta.,16.alpha.,17.alpha.)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furoate

65. (6.alpha.,11.beta.,16.alpha.,17.alpha.)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl-2-furancarboxylate

66. (6alpha,11alpha,14beta,16alpha,17alpha)-6,9-difluoro-17-{[(fluoromethyl)sulfanyl]carbonyl}-11-hydroxy-16-methyl-3-oxoan

67. (6alpha,11alpha,14beta,16alpha,17alpha)-6,9-difluoro-17-{[(fluoromethyl)sulfanyl]carbonyl}-11-hydroxy-16-methyl-3-oxoan Drosta-1,4-dien-17-yl Furan-2-carboxylate

68. (6alpha,11alpha,14beta,16alpha,17alpha)-6,9-difluoro-17-{[(fluoromethyl)sulfanyl]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl Furan-2-carboxylate

69. (6alpha,11beta,16alpha,17alpha)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl-2-furancarboxylate

70. 6.alpha.,9-difluoro-17-(((fluoromethyl)sulfanyl)carbonyl)-11.beta.-hydroxy-16.alpha.-methyl-3-oxoandrosta-1,4-dien-17.alpha.-yl Furan-2-carboxylate

71. 6alpha,9-difluoro-17-(((fluoromethyl)sulfanyl)carbonyl)-11beta-hydroxy-16alpha-methyl-3-oxoandrosta-1,4-dien-17alpha-yl Furan-2-carboxylate

72. 6alpha,9-difluoro-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-11beta-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17alpha-yl 2-furoate

73. 911210-90-7

74. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-17-((2- Furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) Ester, (6alpha,11beta,16alpha,17alpha)-

75. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-17-((2- Furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) Ester, (6alpha,11beta,16alpha,17alpha)-

76. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) Ester, (6.alpha.,11.beta.,16.alpha.,17.alpha.)-

77. Gw6

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 538.6 g/mol
Molecular Formula C27H29F3O6S
XLogP34.8
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count10
Rotatable Bond Count6
Exact Mass538.16369430 g/mol
Monoisotopic Mass538.16369430 g/mol
Topological Polar Surface Area119 Ų
Heavy Atom Count37
Formal Charge0
Complexity1080
Isotope Atom Count0
Defined Atom Stereocenter Count9
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameVeramyst
PubMed HealthFluticasone
Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong
Drug LabelFluticasone furoate, the active component of VERAMYST Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6,11,16,17)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-...
Active IngredientFluticasone furoate
Dosage FormSpray, metered
RouteNasal
Strength0.0275mg/inh
Market StatusPrescription
CompanyGlaxosmithkline

2 of 2  
Drug NameVeramyst
PubMed HealthFluticasone
Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong
Drug LabelFluticasone furoate, the active component of VERAMYST Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6,11,16,17)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-...
Active IngredientFluticasone furoate
Dosage FormSpray, metered
RouteNasal
Strength0.0275mg/inh
Market StatusPrescription
CompanyGlaxosmithkline

4.2 Drug Indication

Fluticasone furoate is indicated as an inhaler for the treatment and management of asthma by prophylaxis. The fluticasone furoate nasal spray is indicated for treating season and perennial allergic rhinitis.


FDA Label


Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.


Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Systemically, in vitro experiments show fluticasone furoate activates glucocorticoid receptors, inhibits nuclear factor kappa b, and inhibits lung eosinophilia in rats.


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
5.3 ATC Code

R01AD12


R01AD12


R - Respiratory system

R01 - Nasal preparations

R01A - Decongestants and other nasal preparations for topical use

R01AD - Corticosteroids

R01AD12 - Fluticasone furoate


R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03B - Other drugs for obstructive airway diseases, inhalants

R03BA - Glucocorticoids

R03BA09 - Fluticasone furoate


5.4 Absorption, Distribution and Excretion

Absorption

Intranasal exposure of fluticasone furoate results in patients swallowing a larger portion of the dose. However, absorption is poor and metabolism is high, therefore there is negligible systemic exposure with a nasal bioavailability of 0.50% and oral bioavialability of 1.26%. Inhaled bioavailability is 13.9%. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 6.3-18.4%.


Route of Elimination

Fluticasone furoate is eliminated 90% in the feces and 1-2% in the urine.


Volume of Distribution

608L at steady state for intravenous administration of fluticasone furoate. Other reports suggest the mean volume of distribution at steady state is 661L. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 704L following intravenous administration.


Clearance

57.8L/h for fluticasone furoate. A study of 24 healthy Caucasian males showed a clearance of 71.8L/h following intravenous administration.


5.5 Metabolism/Metabolites

Fluticasone furoate is cleared from hepatic metabolism by cytochrome P450 3A4. Fluticasone furoate is hydrolysed at the FIVE-S-fluoromethyl carbothioate group, forming an inactive metabolite.


5.6 Biological Half-Life

15.1 hours for intranasal fluticasone furoate and 24 hours for the inhaled formulation. A study of 24 healthy Caucasian males showed a half life of 13.6 hours following intravenous administration and 17.3-23.9 hours followed inhalation.


5.7 Mechanism of Action

Fluticasone furoate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. In vitro experiments show fluticasone furoate activating glucocorticoid receptors, inhibiting nuclear factor kappa b, and inhibiting lung eosinophilia in rats.


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22-Apr-2021
20-Mar-2025
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

Vilfuro-G (vilanterol, fluticasone furoate & glycopyrronium bromide) is world's first fixed-dose triple combination drug which is approved for the treatment of chronic obstructive pulmonary disease (COPD).


Lead Product(s): Vilanterol Trifenatate,Fluticasone Furoate,Glycopyrronium Bromide

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Vilfuro-G

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 23, 2023

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01

Lupin Ltd

India
arrow
Iran Expo
Not Confirmed

Lupin Ltd

India
arrow
Iran Expo
Not Confirmed

Details : Vilfuro-G (vilanterol, fluticasone furoate & glycopyrronium bromide) is world's first fixed-dose triple combination drug which is approved for the treatment of chronic obstructive pulmonary disease (COPD).

Product Name : Vilfuro-G

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 23, 2023

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Details:

A fixed dose combination of vilanterol (adrenergic receptor beta-2 agonist), glycopyrrolate & fluticasone furoate is approved for the treatment of chronic obstructive pulmonary disease.


Lead Product(s): Vilanterol Trifenatate,Fluticasone Furoate,Glycopyrronium Bromide

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 13, 2023

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02

Iran Expo
Not Confirmed
Iran Expo
Not Confirmed

Details : A fixed dose combination of vilanterol (adrenergic receptor beta-2 agonist), glycopyrrolate & fluticasone furoate is approved for the treatment of chronic obstructive pulmonary disease.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 13, 2023

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  • Development Update

Details:

Breo Ellipta ((vilanterol trifenatate, fluticasone furoate) is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, and the long-acting beta2-agonist (LABA) vilanterol. It is now approved for the treatment of pediatric patients with asthma.


Lead Product(s): Vilanterol Trifenatate,Fluticasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breo Ellipta

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 17, 2023

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03

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

Details : Breo Ellipta ((vilanterol trifenatate, fluticasone furoate) is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, and the long-acting beta2-agonist (LABA) vilanterol. It is now approved for the treatment of pediatric patien...

Product Name : Breo Ellipta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 17, 2023

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Details:

The Company now anticipates it will approach breakeven cash flow in the second half of 2022 without the cash flows from its interest in GSK's Trelegy Ellipta (fluticasone furoate) royalties, driven by disciplined spending within R&D and the growth of YUPELRI®.


Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Trelegy Ellipta

Study Phase: Approved FDFProduct Type: Steroid

Sponsor: Royalty Pharma

Deal Size: $1,550.0 million Upfront Cash: $1,100.0 million

Deal Type: Divestment July 13, 2022

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04

Iran Expo
Not Confirmed
Iran Expo
Not Confirmed

Details : The Company now anticipates it will approach breakeven cash flow in the second half of 2022 without the cash flows from its interest in GSK's Trelegy Ellipta (fluticasone furoate) royalties, driven by disciplined spending within R&D and the growth of YUP...

Product Name : Trelegy Ellipta

Product Type : Steroid

Upfront Cash : $1,100.0 million

July 13, 2022

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Details:

Vilor F (vilanterol trifenatate, fluticasone furoate) is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, and the long-acting beta2-agonist (LABA) vilanterol. It is now approved for the treatment of pediatric patients with Asthma & COPD.


Lead Product(s): Vilanterol Trifenatate,Fluticasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Vilor F

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 14, 2022

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05

Iran Expo
Not Confirmed
Iran Expo
Not Confirmed

Details : Vilor F (vilanterol trifenatate, fluticasone furoate) is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, and the long-acting beta2-agonist (LABA) vilanterol. It is now approved for the treatment of pediatric patients wit...

Product Name : Vilor F

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 14, 2022

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  • Development Update

Details:

Trelegy Ellipta (fluticasone furoate) is a glucocorticoid receptor binder which is approved in combination with umeclidinium & vilanterol for the treatment of chronic obstructive pulmonary disease.


Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Trelegy Ellipta

Study Phase: Approved FDFProduct Type: Steroid

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 26, 2022

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06

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

Details : Trelegy Ellipta (fluticasone furoate) is a glucocorticoid receptor binder which is approved in combination with umeclidinium & vilanterol for the treatment of chronic obstructive pulmonary disease.

Product Name : Trelegy Ellipta

Product Type : Steroid

Upfront Cash : Inapplicable

April 26, 2022

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Details:

Vilanterol, a long acting Beta-2 agonist used for the treatment of chronic obstructive pulmonary disease (COPD).


Lead Product(s): Vilanterol Trifenatate,Fluticasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Vilor F

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: GSK

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 19, 2021

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07

Iran Expo
Not Confirmed
Iran Expo
Not Confirmed

Details : Vilanterol, a long acting Beta-2 agonist used for the treatment of chronic obstructive pulmonary disease (COPD).

Product Name : Vilor F

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 19, 2021

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  • Development Update

Details:

Trelegy Ellipta (fluticasone furoate) is a glucocorticoid receptor binder which is being evaluated in phase 4 clinical trials in combination with umeclidinium & vilanterol for the treatment of chronic obstructive pulmonary disease.


Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Trelegy Ellipta

Study Phase: Phase IVProduct Type: Steroid

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 05, 2021

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08

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

Details : Trelegy Ellipta (fluticasone furoate) is a glucocorticoid receptor binder which is being evaluated in phase 4 clinical trials in combination with umeclidinium & vilanterol for the treatment of chronic obstructive pulmonary disease.

Product Name : Trelegy Ellipta

Product Type : Steroid

Upfront Cash : Inapplicable

October 05, 2021

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  • Development Update

Details:

The European Union’s healthcare regulator the European Medicines Agency (EMA) has decided against a label expansion for GlaxoSmithKline (GSK)’s drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include asthma.


Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Trelegy Ellipta

Study Phase: Approved FDFProduct Type: Steroid

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 03, 2021

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09

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

Details : The European Union’s healthcare regulator the European Medicines Agency (EMA) has decided against a label expansion for GlaxoSmithKline (GSK)’s drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include asthma.

Product Name : Trelegy Ellipta

Product Type : Steroid

Upfront Cash : Inapplicable

January 03, 2021

blank
  • Development Update

Details:

FDA has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with COPD.


Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Trelegy Ellipta

Study Phase: Approved FDFProduct Type: Steroid

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 09, 2020

blank

10

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

GSK

United Kingdom
arrow
Iran Expo
Not Confirmed

Details : FDA has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with COPD.

Product Name : Trelegy Ellipta

Product Type : Steroid

Upfront Cash : Inapplicable

September 09, 2020

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Iran Expo
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CAS Number : 527-69-5

End Use API : Fluticasone Furoate

About The Company : Novaphene comprises of two business divisions, Manufacturing - Novaphene Specialities Pvt. Ltd. and Distribution - Novaphene Impex. We are privately managed and...

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - POWDER;INHALATION - 0.05MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.05MG/INH;EQ 0.025MG BASE/INH

USFDA APPLICATION NUMBER - 204275

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DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.025MG BASE/INH

USFDA APPLICATION NUMBER - 204275

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DOSAGE - POWDER;INHALATION - 0.2MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.2MG/INH;EQ 0.025MG BASE/INH

USFDA APPLICATION NUMBER - 204275

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DOSAGE - POWDER;INHALATION - 0.05MG/INH

USFDA APPLICATION NUMBER - 205625

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DOSAGE - POWDER;INHALATION - 0.1MG/INH

USFDA APPLICATION NUMBER - 205625

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DOSAGE - POWDER;INHALATION - 0.2MG/INH

USFDA APPLICATION NUMBER - 205625

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DOSAGE - SPRAY, METERED;NASAL - 0.0275MG/SPRA...DOSAGE - SPRAY, METERED;NASAL - 0.0275MG/SPRAY

USFDA APPLICATION NUMBER - 22051

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ABOUT THIS PAGE

Looking for 397864-44-7 / Fluticasone Furoate API manufacturers, exporters & distributors?

Fluticasone Furoate manufacturers, exporters & distributors 1

31

PharmaCompass offers a list of Fluticasone Furoate 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 Fluticasone Furoate manufacturer or Fluticasone Furoate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluticasone Furoate manufacturer or Fluticasone Furoate supplier.

PharmaCompass also assists you with knowing the Fluticasone Furoate API Price utilized in the formulation of products. Fluticasone Furoate API Price is not always fixed or binding as the Fluticasone Furoate Price is obtained through a variety of data sources. The Fluticasone Furoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Fluticasone Furoate

Synonyms

Veramyst, Avamys, 397864-44-7, Allermist, Furamist, Arnuity ellipta

Cas Number

397864-44-7

Unique Ingredient Identifier (UNII)

JS86977WNV

About Fluticasone Furoate

Fluticasone Furoate is the furoate salt form of fluticasone, a synthetic trifluorinated glucocorticoid receptor agonist with anti-allergic, anti-inflammatory and anti-pruritic effects. Upon administration, fluticasone binds to and activates glucocorticoid receptor, resulting in the activation of lipocortin. Lipocortin, in turn, inhibits cytosolic phospholipase A2 and the cascade of reactions involved in the synthesis of inflammatory mediators, such as prostaglandins and leukotrienes. Secondly, mitogen-activated protein kinase (MAPK) phosphatase 1 is induced, which leads to dephosphorylation and inactivation of Jun N-terminal kinase and directly inhibits c-Jun mediated transcription. Finally, transcriptional activity of nuclear factor (NF)-kappa-B is blocked, thereby inhibiting the transcription of cyclooxygenase 2 (COX-2), which is essential for prostaglandin production.

Veramyst Manufacturers

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

Veramyst Suppliers

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

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

Veramyst USDMF

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

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

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

Veramyst JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Veramyst Drug Master File in Japan (Veramyst JDMF) empowers Veramyst API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Veramyst JDMF during the approval evaluation for pharmaceutical products. At the time of Veramyst JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Veramyst suppliers with JDMF on PharmaCompass.

Veramyst KDMF

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

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

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

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

Veramyst CEP

A Veramyst CEP of the European Pharmacopoeia monograph is often referred to as a Veramyst Certificate of Suitability (COS). The purpose of a Veramyst CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Veramyst EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Veramyst to their clients by showing that a Veramyst CEP has been issued for it. The manufacturer submits a Veramyst CEP (COS) as part of the market authorization procedure, and it takes on the role of a Veramyst CEP holder for the record. Additionally, the data presented in the Veramyst CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Veramyst DMF.

A Veramyst CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Veramyst CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Veramyst suppliers with CEP (COS) on PharmaCompass.

Veramyst WC

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

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

Veramyst 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 Veramyst as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Veramyst GMP

Veramyst 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 Veramyst 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 Veramyst GMP manufacturer or Veramyst GMP API supplier for your needs.

Veramyst CoA

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

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

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