Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
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1. Cutivate
2. Flixonase
3. Flixotide
4. Flonase
5. Flovent
6. Flovent Hfa
7. Fluticasone
8. Hfa, Flovent
9. Propionate, Fluticasone
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
| Molecular Weight | 500.6 g/mol |
|---|---|
| Molecular Formula | C25H31F3O5S |
| XLogP3 | 4 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 6 |
| Exact Mass | 500.18442974 g/mol |
| Monoisotopic Mass | 500.18442974 g/mol |
| Topological Polar Surface Area | 106 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 984 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 9 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 14 | |
|---|---|
| Drug Name | Cutivate |
| PubMed Health | Fluticasone |
| Drug Classes | Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong |
| Drug Label | CUTIVATE (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 Ingredient | Fluticasone propionate |
| Dosage Form | Lotion; Ointment |
| Route | Topical |
| Strength | 0.05%; 0.005% |
| Market Status | Prescription |
| Company | Fougera Pharms |
| 2 of 14 | |
|---|---|
| Drug Name | Flonase |
| Drug Label | The 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 Ingredient | Fluticasone propionate |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.05mg/spray |
| Market Status | Prescription |
| Company | Glaxosmithkline |
| 3 of 14 | |
|---|---|
| Drug Name | Flovent diskus 100 |
| Active Ingredient | Fluticasone propionate |
| Dosage Form | Powder |
| Route | Inhalation |
| Strength | 0.1mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 4 of 14 | |
|---|---|
| Drug Name | Flovent diskus 250 |
| Drug Label | Fluticasone 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 Ingredient | Fluticasone propionate |
| Dosage Form | Powder |
| Route | Inhalation |
| Strength | 0.25mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 5 of 14 | |
|---|---|
| Drug Name | Flovent diskus 50 |
| Active Ingredient | Fluticasone propionate |
| Dosage Form | Powder |
| Route | Inhalation |
| Strength | 0.05mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 6 of 14 | |
|---|---|
| Drug Name | Flovent hfa |
| Active Ingredient | Fluticasone propionate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | 0.22mg/inh; 0.11mg/inh; 0.044mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 7 of 14 | |
|---|---|
| Drug Name | Fluticasone propionate |
| Drug Label | Fluticasone 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 Ingredient | Fluticasone propionate |
| Dosage Form | Ointment; Spray, metered; Cream; Lotion |
| Route | Nasal; Topical |
| Strength | 0.05%; 0.005%; 0.05mg/spray |
| Market Status | Prescription |
| Company | Wockhardt; Apotex; Roxane; Glenmark Generics; Fougera Pharms; Hi Tech Pharma; Perrigo New York; Tolmar; G And W Labs; Perrigo Israel |
| 8 of 14 | |
|---|---|
| Drug Name | Flovent diskus 250 |
| Drug Label | Fluticasone 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 Ingredient | Fluticasone propionate |
| Dosage Form | Powder |
| Route | Inhalation |
| Strength | 0.25mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 9 of 14 | |
|---|---|
| Drug Name | Flovent diskus 50 |
| Active Ingredient | Fluticasone propionate |
| Dosage Form | Powder |
| Route | Inhalation |
| Strength | 0.05mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 10 of 14 | |
|---|---|
| Drug Name | Flovent hfa |
| Active Ingredient | Fluticasone propionate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | 0.22mg/inh; 0.11mg/inh; 0.044mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 11 of 14 | |
|---|---|
| Drug Name | Fluticasone propionate |
| Drug Label | Fluticasone 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 Ingredient | Fluticasone propionate |
| Dosage Form | Ointment; Spray, metered; Cream; Lotion |
| Route | Nasal; Topical |
| Strength | 0.05%; 0.005%; 0.05mg/spray |
| Market Status | Prescription |
| Company | Wockhardt; Apotex; Roxane; Glenmark Generics; Fougera Pharms; Hi Tech Pharma; Perrigo New York; Tolmar; G And W Labs; Perrigo Israel |
| 12 of 14 | |
|---|---|
| Drug Name | Cutivate |
| PubMed Health | Fluticasone |
| Drug Classes | Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong |
| Drug Label | CUTIVATE (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 Ingredient | Fluticasone propionate |
| Dosage Form | Lotion; Ointment |
| Route | Topical |
| Strength | 0.05%; 0.005% |
| Market Status | Prescription |
| Company | Fougera Pharms |
| 13 of 14 | |
|---|---|
| Drug Name | Flonase |
| Drug Label | The 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 Ingredient | Fluticasone propionate |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.05mg/spray |
| Market Status | Prescription |
| Company | Glaxosmithkline |
| 14 of 14 | |
|---|---|
| Drug Name | Flovent diskus 100 |
| Active Ingredient | Fluticasone propionate |
| Dosage Form | Powder |
| Route | Inhalation |
| Strength | 0.1mg/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
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
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.
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.)
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.
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.
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.
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.
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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
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
DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
USFDA APPLICATION NUMBER - 202236
DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY
USFDA APPLICATION NUMBER - 205434
DOSAGE - POWDER;INHALATION - 0.05MG/INH
USFDA APPLICATION NUMBER - 20833
DOSAGE - POWDER;INHALATION - 0.1MG/INH
USFDA APPLICATION NUMBER - 20833
DOSAGE - POWDER;INHALATION - 0.25MG/INH
USFDA APPLICATION NUMBER - 20833
DOSAGE - POWDER;INHALATION - 0.03MG/INH
USFDA APPLICATION NUMBER - 208798
DOSAGE - POWDER;INHALATION - 0.055MG/INH
USFDA APPLICATION NUMBER - 208798
DOSAGE - POWDER;INHALATION - 0.113MG/INH
USFDA APPLICATION NUMBER - 208798
DOSAGE - POWDER;INHALATION - 0.232MG/INH
USFDA APPLICATION NUMBER - 208798
DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH
USFDA APPLICATION NUMBER - 208799
DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH
USFDA APPLICATION NUMBER - 208799
DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH
USFDA APPLICATION NUMBER - 208799
DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH
USFDA APPLICATION NUMBER - 21077
DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH
USFDA APPLICATION NUMBER - 21077
DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH
USFDA APPLICATION NUMBER - 21077
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
DOSAGE - AEROSOL, METERED;INHALATION - 0.045M...DOSAGE - AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH
USFDA APPLICATION NUMBER - 21254
DOSAGE - AEROSOL, METERED;INHALATION - 0.115M...DOSAGE - AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH
USFDA APPLICATION NUMBER - 21254
DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH
USFDA APPLICATION NUMBER - 21254
DOSAGE - AEROSOL, METERED;INHALATION - 0.044M...DOSAGE - AEROSOL, METERED;INHALATION - 0.044MG/INH
USFDA APPLICATION NUMBER - 21433
DOSAGE - AEROSOL, METERED;INHALATION - 0.11MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.11MG/INH
USFDA APPLICATION NUMBER - 21433
DOSAGE - AEROSOL, METERED;INHALATION - 0.22MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.22MG/INH
USFDA APPLICATION NUMBER - 21433
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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.
A Fluticasone Propionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluticasone Propionate, including repackagers and relabelers. The FDA regulates Fluticasone Propionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluticasone Propionate 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 Propionate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluticasone Propionate supplier is an individual or a company that provides Fluticasone Propionate active pharmaceutical ingredient (API) or Fluticasone Propionate finished formulations upon request. The Fluticasone Propionate suppliers may include Fluticasone Propionate API manufacturers, exporters, distributors and traders.
click here to find a list of Fluticasone Propionate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluticasone Propionate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluticasone Propionate active pharmaceutical ingredient (API) in detail. Different forms of Fluticasone Propionate DMFs exist exist since differing nations have different regulations, such as Fluticasone Propionate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluticasone Propionate DMF submitted to regulatory agencies in the US is known as a USDMF. Fluticasone Propionate USDMF includes data on Fluticasone Propionate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluticasone Propionate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluticasone Propionate suppliers with USDMF on PharmaCompass.
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 Propionate Drug Master File in Japan (Fluticasone Propionate JDMF) empowers Fluticasone Propionate 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 Propionate JDMF during the approval evaluation for pharmaceutical products. At the time of Fluticasone Propionate 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 Propionate suppliers with JDMF 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 Fluticasone Propionate Drug Master File in Korea (Fluticasone Propionate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fluticasone Propionate. The MFDS reviews the Fluticasone Propionate KDMF as part of the drug registration process and uses the information provided in the Fluticasone Propionate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fluticasone Propionate 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 Propionate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fluticasone Propionate suppliers with KDMF on PharmaCompass.
A Fluticasone Propionate CEP of the European Pharmacopoeia monograph is often referred to as a Fluticasone Propionate Certificate of Suitability (COS). The purpose of a Fluticasone Propionate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluticasone Propionate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluticasone Propionate to their clients by showing that a Fluticasone Propionate CEP has been issued for it. The manufacturer submits a Fluticasone Propionate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluticasone Propionate CEP holder for the record. Additionally, the data presented in the Fluticasone Propionate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluticasone Propionate DMF.
A Fluticasone Propionate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluticasone Propionate 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 Propionate suppliers with CEP (COS) on PharmaCompass.
A Fluticasone Propionate written confirmation (Fluticasone Propionate WC) is an official document issued by a regulatory agency to a Fluticasone Propionate manufacturer, verifying that the manufacturing facility of a Fluticasone Propionate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fluticasone Propionate APIs or Fluticasone Propionate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fluticasone Propionate WC (written confirmation) as part of the regulatory process.
click here to find a list of Fluticasone Propionate 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 Fluticasone Propionate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fluticasone Propionate 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 Fluticasone Propionate 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 Fluticasone Propionate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluticasone Propionate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fluticasone Propionate suppliers with NDC on PharmaCompass.
Fluticasone Propionate 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 Propionate 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 Propionate GMP manufacturer or Fluticasone Propionate GMP API supplier for your needs.
A Fluticasone Propionate CoA (Certificate of Analysis) is a formal document that attests to Fluticasone Propionate's compliance with Fluticasone Propionate specifications and serves as a tool for batch-level quality control.
Fluticasone Propionate CoA mostly includes findings from lab analyses of a specific batch. For each Fluticasone Propionate 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 Propionate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluticasone Propionate EP), Fluticasone Propionate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluticasone Propionate USP).
