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Chemistry

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Also known as: 80474-14-2, Flovent, Cutivate, Flixotide, Flonase, Flixonase
Molecular Formula
C25H31F3O5S
Molecular Weight
500.6  g/mol
InChI Key
WMWTYOKRWGGJOA-CENSZEJFSA-N
FDA UNII
O2GMZ0LF5W

Fluticasone Propionate
A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.
1 2D Structure

Fluticasone Propionate

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] propanoate
2.1.2 InChI
InChI=1S/C25H31F3O5S/c1-5-20(31)33-25(21(32)34-12-26)13(2)8-15-16-10-18(27)17-9-14(29)6-7-22(17,3)24(16,28)19(30)11-23(15,25)4/h6-7,9,13,15-16,18-19,30H,5,8,10-12H2,1-4H3/t13-,15+,16+,18+,19+,22+,23+,24+,25+/m1/s1
2.1.3 InChI Key
WMWTYOKRWGGJOA-CENSZEJFSA-N
2.1.4 Canonical SMILES
CCC(=O)OC1(C(CC2C1(CC(C3(C2CC(C4=CC(=O)C=CC43C)F)F)O)C)C)C(=O)SCF
2.1.5 Isomeric SMILES
CCC(=O)O[C@@]1([C@@H](C[C@@H]2[C@@]1(C[C@@H]([C@]3([C@H]2C[C@@H](C4=CC(=O)C=C[C@@]43C)F)F)O)C)C)C(=O)SCF
2.2 Other Identifiers
2.2.1 UNII
O2GMZ0LF5W
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cutivate

2. Flixonase

3. Flixotide

4. Flonase

5. Flovent

6. Flovent Hfa

7. Fluticasone

8. Hfa, Flovent

9. Propionate, Fluticasone

2.3.2 Depositor-Supplied Synonyms

1. 80474-14-2

2. Flovent

3. Cutivate

4. Flixotide

5. Flonase

6. Flixonase

7. Flovent Hfa

8. Flunase

9. Flusonal

10. Fluspiral

11. Flutide

12. Flutivate

13. Asmatil

14. Axotide

15. Brethal

16. Fluinol

17. Flovent Diskus 50

18. Flixotide Disks

19. Flixotide Disk

20. Flovent Diskus

21. Flovent Diskus 100

22. Flovent Diskus 250

23. Flixotide Inhaler

24. Cultivate

25. Flixonase Nasal Spray

26. Fluticasonpropionat Allen

27. Cci-18781

28. Xhance

29. Fluticasone (propionate)

30. Cci 18781

31. Armonair Respiclick

32. Fluticasone-17-propionate

33. O2gmz0lf5w

34. Atemur

35. Chebi:31441

36. Nsc-759889

37. Inalacor

38. Rinosone

39. Trialona

40. Ubizol

41. Zoflut

42. Fluticasone Propionate (flonase, Veramyst)

43. Mfcd00866007

44. Flonase Aq

45. Pf-00241939

46. [(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] Propanoate

47. Flovent-hfa

48. Fluticasone Propionate [usan]

49. Unii-o2gmz0lf5w

50. Fluxonal

51. Skyron

52. Flovent Rotadisk

53. Cutivate (tn)

54. Fluticasone Propionate [usan:usp]

55. Flonase (tn)

56. Flovent (tn)

57. Fluticasone-propionate

58. Armonair Respiclicktm

59. Flonase Allergy Relief

60. Fluticasone Impurity B

61. Prestwick0_000997

62. Prestwick1_000997

63. Prestwick2_000997

64. Prestwick3_000997

65. Cci18781

66. Schembl4068

67. Chembl1473

68. Bspbio_001093

69. Mls001424085

70. S-(fluoromethyl) 6alpha,9-difluoro-11beta,17-dihydroxy-16alpha-methyl-3-oxoandrosta-1,4-diene-17beta-carbothioate, 17-propionate

71. Fluticasone Propionate- Bio-x

72. Spbio_002984

73. Bpbio1_001203

74. Gtpl7080

75. Dtxsid8045511

76. Fluticasone Propionate (jan/usp)

77. Fn-25

78. Hms1571g15

79. Hms2051n19

80. Hms2098g15

81. Hms3413a19

82. Hms3677a19

83. Hms3715g15

84. Fluticasone Propionate [mi]

85. Amy38235

86. Hy-b0154

87. Ymb56612

88. Zinc3920027

89. Fluticasone Propionate [jan]

90. Ac-457

91. Bdbm50354849

92. S1992

93. Fluticasone Propionate [vandf]

94. Akos015895220

95. Fluticasone Propionate [mart.]

96. Ccg-100981

97. Cci-187881

98. Cs-1986

99. Db00588

100. Fluticasone Propionate [usp-rs]

101. Fluticasone Propionate [who-dd]

102. Ks-1173

103. Nc00231

104. Nsc 759889

105. Ncgc00179308-01

106. Ncgc00179308-05

107. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-, (6alpha,11beta,16alpha,17alpha)-s-(fluoromethyl) Ester

108. Bf160362

109. Bf161262

110. Smr000469159

111. Fluticasone Propionate [orange Book]

112. Ab00513992

113. Fluticasone Propionate [ep Monograph]

114. Advair Component Fluticasone Propionate

115. Fluticasone Propionate [usp Monograph]

116. A51110

117. D01708

118. Dymista Component Fluticasone Propionate

119. Ab00513992-06

120. Ab00513992_08

121. Fluticasone Propionate - Micronised Pharma Grade

122. Fluticasone Propionate Component Of Advair

123. Fluticasone Propionate, >=98% (hplc), Powder

124. 474f142

125. Advair Hfa Component Fluticasone Propionate

126. An-584/43505443

127. Fluticasone Propionate 100 Microg/ml In Methanol

128. Fluticasone Propionate Component Of Dymista

129. Lipo-102 Component Fluticasone Propionate

130. Sr-01000763355

131. Q-101393

132. Q8564098

133. Sr-01000763355-3

134. Brd-k62310379-001-03-0

135. Fluticasone Propionate 100 Microg/ml In Acetonitrile

136. Fluticasone Propionate Component Of Advair Hfa

137. Airduo Respiclick Component Fluticasone Propionate

138. Fluticasone 17(2)-carbonylsulfenic Acid 17-propionate

139. Fluticasone Propionate Component Of Airduo Respiclick

140. Fluticasone Propionate, European Pharmacopoeia (ep) Reference Standard

141. Fluticasone Propionate, United States Pharmacopeia (usp) Reference Standard

142. Fluticasone Propionate, Pharmaceutical Secondary Standard; Certified Reference Material

143. (1r,2s,8s,10s,11s,13r,14r,15s,17s)-1,8-difluoro-14-{[(fluoromethyl)sulfanyl]carbonyl}-17-hydroxy-2,13,15-trimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-14-yl Propanoate

144. (6?,11?,16?,17?)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic Acid Fluoromethyl Ester

145. 6alpha,9-difluoro-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-11beta-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17alpha-yl Propanoate

146. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-, (6.alpha.,11.beta.,16.alpha.,17.alpha.)-s-(fluoromethyl) Ester

147. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-,s-(fluoromethyl) Ester, (6.alpha.,11.beta.,16.alpha.,17.alpha.)-

148. Fluticasone Propionate For Impurity C Identification, Europepharmacopoeia (ep) Reference Standard

149. Fluticasone Propionate For Impurity G Identification, Europepharmacopoeia (ep) Reference Standard

150. S-fluoromethyl 6.alpha., 9.alpha.-difluoro-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-17.alpha.-propionyloxyandrosta-1,4-diene-17.beta-. Carbothioate

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 500.6 g/mol
Molecular Formula C25H31F3O5S
XLogP34
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count9
Rotatable Bond Count6
Exact Mass500.18442974 g/mol
Monoisotopic Mass500.18442974 g/mol
Topological Polar Surface Area106 Ų
Heavy Atom Count34
Formal Charge0
Complexity984
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 14  
Drug NameCutivate
PubMed HealthFluticasone
Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong
Drug LabelCUTIVATE (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6,11,16,17)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorina...
Active IngredientFluticasone propionate
Dosage FormLotion; Ointment
RouteTopical
Strength0.05%; 0.005%
Market StatusPrescription
CompanyFougera Pharms

2 of 14  
Drug NameFlonase
Drug LabelThe active component of FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, and FLOVENT HFA 220 mcg Inhalation Aerosol is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6,9-difluoro-11...
Active IngredientFluticasone propionate
Dosage FormSpray, metered
RouteNasal
Strength0.05mg/spray
Market StatusPrescription
CompanyGlaxosmithkline

3 of 14  
Drug NameFlovent diskus 100
Active IngredientFluticasone propionate
Dosage FormPowder
RouteInhalation
Strength0.1mg/inh
Market StatusPrescription
CompanyGlaxo Grp

4 of 14  
Drug NameFlovent diskus 250
Drug LabelFluticasone propionate, the active component of Fluticasone Propionate Nasal Spray USP, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6,9-difluoro-11-17-dihydroxy-16-methyl-3-oxoandrosta-1,4-diene-17-carbothioate, 17-...
Active IngredientFluticasone propionate
Dosage FormPowder
RouteInhalation
Strength0.25mg/inh
Market StatusPrescription
CompanyGlaxo Grp

5 of 14  
Drug NameFlovent diskus 50
Active IngredientFluticasone propionate
Dosage FormPowder
RouteInhalation
Strength0.05mg/inh
Market StatusPrescription
CompanyGlaxo Grp

6 of 14  
Drug NameFlovent hfa
Active IngredientFluticasone propionate
Dosage FormAerosol, metered
RouteInhalation
Strength0.22mg/inh; 0.11mg/inh; 0.044mg/inh
Market StatusPrescription
CompanyGlaxo Grp

7 of 14  
Drug NameFluticasone propionate
Drug LabelFluticasone propionate, the active component of FLONASE Nasal Spray, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6,9-difluoro-11-17-dihydroxy-16-methyl-3-oxoandrosta-1,4-diene-17-carbothioate, 17-propionate and the...
Active IngredientFluticasone propionate
Dosage FormOintment; Spray, metered; Cream; Lotion
RouteNasal; Topical
Strength0.05%; 0.005%; 0.05mg/spray
Market StatusPrescription
CompanyWockhardt; Apotex; Roxane; Glenmark Generics; Fougera Pharms; Hi Tech Pharma; Perrigo New York; Tolmar; G And W Labs; Perrigo Israel

8 of 14  
Drug NameFlovent diskus 250
Drug LabelFluticasone propionate, the active component of Fluticasone Propionate Nasal Spray USP, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6,9-difluoro-11-17-dihydroxy-16-methyl-3-oxoandrosta-1,4-diene-17-carbothioate, 17-...
Active IngredientFluticasone propionate
Dosage FormPowder
RouteInhalation
Strength0.25mg/inh
Market StatusPrescription
CompanyGlaxo Grp

9 of 14  
Drug NameFlovent diskus 50
Active IngredientFluticasone propionate
Dosage FormPowder
RouteInhalation
Strength0.05mg/inh
Market StatusPrescription
CompanyGlaxo Grp

10 of 14  
Drug NameFlovent hfa
Active IngredientFluticasone propionate
Dosage FormAerosol, metered
RouteInhalation
Strength0.22mg/inh; 0.11mg/inh; 0.044mg/inh
Market StatusPrescription
CompanyGlaxo Grp

11 of 14  
Drug NameFluticasone propionate
Drug LabelFluticasone propionate, the active component of FLONASE Nasal Spray, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6,9-difluoro-11-17-dihydroxy-16-methyl-3-oxoandrosta-1,4-diene-17-carbothioate, 17-propionate and the...
Active IngredientFluticasone propionate
Dosage FormOintment; Spray, metered; Cream; Lotion
RouteNasal; Topical
Strength0.05%; 0.005%; 0.05mg/spray
Market StatusPrescription
CompanyWockhardt; Apotex; Roxane; Glenmark Generics; Fougera Pharms; Hi Tech Pharma; Perrigo New York; Tolmar; G And W Labs; Perrigo Israel

12 of 14  
Drug NameCutivate
PubMed HealthFluticasone
Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong
Drug LabelCUTIVATE (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6,11,16,17)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorina...
Active IngredientFluticasone propionate
Dosage FormLotion; Ointment
RouteTopical
Strength0.05%; 0.005%
Market StatusPrescription
CompanyFougera Pharms

13 of 14  
Drug NameFlonase
Drug LabelThe active component of FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, and FLOVENT HFA 220 mcg Inhalation Aerosol is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6,9-difluoro-11...
Active IngredientFluticasone propionate
Dosage FormSpray, metered
RouteNasal
Strength0.05mg/spray
Market StatusPrescription
CompanyGlaxosmithkline

14 of 14  
Drug NameFlovent diskus 100
Active IngredientFluticasone propionate
Dosage FormPowder
RouteInhalation
Strength0.1mg/inh
Market StatusPrescription
CompanyGlaxo Grp

4.2 Drug Indication

Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxisas well as inflammatory and pruritic dermatoses. Fluticasone propionate nasal spray is indicated for managing allergic and nonallergic rhinitis.


FDA Label


Treatment of asthma


5 Pharmacology and Biochemistry
5.1 Pharmacology

Systemically, fluticasone propionate activates glucocorticoid receptors, and inhibits lung eosinophilia in rats. Fluticasone propionate as a topical formulation is also associated with vasoconstriction in the skin.


5.2 MeSH Pharmacological Classification

Anti-Allergic Agents

Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)


Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


Bronchodilator Agents

Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)


Dermatologic Agents

Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
5.4 Absorption, Distribution and Excretion

Absorption

Intranasal bioavailability of fluticasone propionate is <2%, and oral bioavailability is <1%. Intranasal exposure results in the majority of the dose being swallowed. Topical absorption of fluticasone propionate is very low but can change depending on a number of factors including integrity of the skin and the presence of inflammation or disease. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 9.0%.


Route of Elimination

Fluticasone propionate is mainly eliminated in the feces with <5% eliminated in the urine.


Volume of Distribution

The volume of distribution of intravenous fluticasone propionate is 4.2L/kg. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 577L following intravenous administration.


Clearance

1093mL/min for fluticasone propionate. A study of 24 healthy Caucasian males showed a clearance of 63.9L/h following intravenous administration.


5.5 Metabolism/Metabolites

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


5.6 Biological Half-Life

7.8 hours for intravenous fluticasone propionate. A study of 24 healthy Caucasian males shows a half life of 14.0 hours following intravenous administration and 10.8 hours following inhalation.


5.7 Mechanism of Action

Fluticasone propionate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. Fluticasone propionate activates glucocorticoid receptors and inhibits lung eosinophilia in rats.


API Reference Price

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CHEMO IBERICA, S.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"0.35","actualQuantity":"0.35","unit":"KGS","unitRateFc":"25000","totalValueFC":"8861.1","currency":"USD","unitRateINR":"2107500","date":"14-Dec-2023","totalValueINR":"737625","totalValueInUsd":"8861.1","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"9223390","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO, 28, 3RD FLOOR28050 MADRID -SPAINSDNF ES","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704738600,"product":"FLUTICASONE PROPIONATE MICRONIZED","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"M\/S.CHEMO IBERICA, S.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.502","unit":"KGS","unitRateFc":"25000","totalValueFC":"12721.9","currency":"USD","unitRateINR":"2106250","date":"09-Jan-2024","totalValueINR":"1057337.5","totalValueInUsd":"12721.9","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"9588216","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO, 28, 3RDFLOOR 28050 MADRID -SPAINSDNF ES","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705257000,"product":"FLUTICASONE FUROATE (BATCH NO.FFPC-007\/23T 23PS0021) (20 GMS) FLUTICASONE FUROATE PRECIPITATE MICRONIZED","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"STERLING SPA","supplierCountry":"ITALY","foreign_port":"ROME","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"75000","totalValueFC":"1520.5","currency":"USD","unitRateINR":"6318750","date":"15-Jan-2024","totalValueINR":"126375","totalValueInUsd":"1520.5","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"9672574","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"ROME","supplierAddress":"VIA DELLA CARBONERIA 30 06073 SOLOMEO DI CORCIANO-PG ITALY, , ItalySDNF Italy","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708713000,"product":"FLUTICASONE PROPIONATE MICRONIZED (BATCH : PR240222)","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"M\/S. CHEMO IBERICA, S.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"25000","totalValueFC":"6319.8","currency":"USD","unitRateINR":"2097500","date":"24-Feb-2024","totalValueINR":"524375","totalValueInUsd":"6319.8","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"2291527","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO, 28, 3RD FLOOR28050 MADRID -SPAINSDNF ES","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710700200,"product":"FLUTICASONE PROPIONATE MICRONIZED","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"35000","totalValueFC":"882.5","currency":"USD","unitRateINR":"2931250","date":"18-Mar-2024","totalValueINR":"73281.25","totalValueInUsd":"882.5","indian_port":"Hyderabad Air","hs_no":"29372200","bill_no":"2632167","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO,28,3RD FLOOR 28050 MADRID SPAIN Madrid, , SpainSDNF Spain","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712169000,"product":"FLUTICASONE PROPIONATE MICRONIZED","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"M\/S. CHEMO IBERICA, S.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"25000","totalValueFC":"6286.9","currency":"USD","unitRateINR":"2100000","date":"04-Apr-2024","totalValueINR":"525000","totalValueInUsd":"6286.9","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"2876885","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO, 28, 3RD FLOOR28050 MADRID -SPAINSDNF ES","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"FLUTICASONE PROPIONATE (MICRONISED) IP","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"GSK","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"GSK","customerCountry":"INDIA","quantity":"2.38","actualQuantity":"2381","unit":"GMS","unitRateFc":"40","totalValueFC":"127799.3","currency":"GBP","unitRateINR":"4498","date":"25-Sep-2024","totalValueINR":"10709738","totalValueInUsd":"127799.3","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"5794112","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Micronized","supplierPort":"LONDON - HEATHROW","supplierAddress":"79 NEW OXFORD STREET LONDON WC1A 1D G UNITED KINGDOM London, , United K ingdom United Kingdom","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737397800,"product":"FLUTICASONE PROPIONATE, BATCH NO FTC-009\/21 L22653A1 FLUTICASONE PROPIONATE, BATCH NO FTC-009\/21 L22653A1","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"STERLING SPA","supplierCountry":"ITALY","foreign_port":"ROME","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.40","actualQuantity":"400","unit":"GMS","unitRateFc":"65","totalValueFC":"26262.6","currency":"USD","unitRateINR":"5661.5","date":"21-Jan-2025","totalValueINR":"2264600","totalValueInUsd":"26262.6","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"7910414","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROME","supplierAddress":"VIA DELLA CARBONERIA, 30 SOLOMEO 06 073 CORCIANO PERUGIA - SDNF","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
30-Jan-2021
28-Feb-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - OINTMENT;TOPICAL - 0.005% **Federal ...DOSAGE - OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19957

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DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY ...DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20121

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DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY

USFDA APPLICATION NUMBER - 202236

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DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY

USFDA APPLICATION NUMBER - 205434

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DOSAGE - POWDER;INHALATION - 0.05MG/INH

USFDA APPLICATION NUMBER - 20833

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DOSAGE - POWDER;INHALATION - 0.1MG/INH

USFDA APPLICATION NUMBER - 20833

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DOSAGE - POWDER;INHALATION - 0.25MG/INH

USFDA APPLICATION NUMBER - 20833

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DOSAGE - POWDER;INHALATION - 0.03MG/INH

USFDA APPLICATION NUMBER - 208798

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DOSAGE - POWDER;INHALATION - 0.055MG/INH

USFDA APPLICATION NUMBER - 208798

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DOSAGE - POWDER;INHALATION - 0.113MG/INH

USFDA APPLICATION NUMBER - 208798

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DOSAGE - POWDER;INHALATION - 0.232MG/INH

USFDA APPLICATION NUMBER - 208798

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DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH

USFDA APPLICATION NUMBER - 208799

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DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH

USFDA APPLICATION NUMBER - 208799

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DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH

USFDA APPLICATION NUMBER - 208799

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DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH

USFDA APPLICATION NUMBER - 21077

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DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH

USFDA APPLICATION NUMBER - 21077

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DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH

USFDA APPLICATION NUMBER - 21077

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DOSAGE - LOTION;TOPICAL - 0.05% **Federal Reg...DOSAGE - LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21152

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DOSAGE - AEROSOL, METERED;INHALATION - 0.045M...DOSAGE - AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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DOSAGE - AEROSOL, METERED;INHALATION - 0.115M...DOSAGE - AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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DOSAGE - AEROSOL, METERED;INHALATION - 0.044M...DOSAGE - AEROSOL, METERED;INHALATION - 0.044MG/INH

USFDA APPLICATION NUMBER - 21433

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DOSAGE - AEROSOL, METERED;INHALATION - 0.11MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.11MG/INH

USFDA APPLICATION NUMBER - 21433

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DOSAGE - AEROSOL, METERED;INHALATION - 0.22MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.22MG/INH

USFDA APPLICATION NUMBER - 21433

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ABOUT THIS PAGE

Looking for 80474-14-2 / Fluticasone Propionate API manufacturers, exporters & distributors?

Fluticasone Propionate manufacturers, exporters & distributors 1

24

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

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

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

API | Excipient name

Fluticasone Propionate

Synonyms

80474-14-2, Flovent, Cutivate, Flixotide, Flonase, Flixonase

Cas Number

80474-14-2

Unique Ingredient Identifier (UNII)

O2GMZ0LF5W

About Fluticasone Propionate

A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.

Fluticasone Manufacturers

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

Fluticasone Suppliers

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

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

Fluticasone USDMF

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

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

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

Fluticasone 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 Fluticasone Drug Master File in Japan (Fluticasone JDMF) empowers Fluticasone 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 Fluticasone JDMF during the approval evaluation for pharmaceutical products. At the time of Fluticasone 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 Fluticasone suppliers with JDMF on PharmaCompass.

Fluticasone KDMF

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

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

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

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

Fluticasone CEP

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

A Fluticasone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluticasone 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 Fluticasone suppliers with CEP (COS) on PharmaCompass.

Fluticasone WC

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

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

Fluticasone 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 Fluticasone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fluticasone GMP

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

Fluticasone CoA

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

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

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