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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 | |
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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.
Certificate Number : R1-CEP 2018-040 - Rev 00
Issue Date : 2023-05-03
Type : Chemical
Substance Number : 1750
Status : Valid
Registration Number : 303MF10172
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2021-12-09
Latest Date of Registration :
Registrant Name : Korea Mundipharma Co., Ltd.
Registration Date : 2024-05-31
Registration Number : 20240531-209-J-1652
Manufacturer Name : Euroapi France
Manufacturer Address : 4 Lieu Dit La Paterie, Vertolaye, 63480, France
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-11
Pay. Date : 2018-04-10
DMF Number : 21879
Submission : 2008-08-12
Status : Active
Type : II
Certificate Number : R0-CEP 2021-492 - Rev 00
Issue Date : 2023-06-01
Type : Chemical
Substance Number : 1750
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009n
Address of the Firm :
NDC Package Code : 49076-5501
Start Marketing Date : 2018-10-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40285
Submission : 2024-08-13
Status : Active
Type : II
Certificate Number : CEP 2020-078 - Rev 02
Issue Date : 2023-12-11
Type : Chemical
Substance Number : 1750
Status : Valid
Date of Issue : 2022-06-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0155
Address of the Firm :
NDC Package Code : 66412-0679
Start Marketing Date : 2023-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-23
Pay. Date : 2014-05-05
DMF Number : 15456
Submission : 2001-05-24
Status : Active
Type : II
Certificate Number : CEP 2007-192 - Rev 09
Issue Date : 2024-11-26
Type : Chemical
Substance Number : 1750
Status : Valid
Registration Number : 218MF10834
Registrant's Address : Offer Park, Building C, 4th floor, 94 Shlomo Shmeltzer Road, POB 3158, Petah Tikva 4970602, Israel
Initial Date of Registration : 2006-10-20
Latest Date of Registration :
Available Reg Filing : ASMF |
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DMF Review : Reviewed
Rev. Date : 2018-11-02
Pay. Date : 2018-10-31
DMF Number : 20463
Submission : 2007-04-24
Status : Active
Type : II
Certificate Number : CEP 2008-117 - Rev 02
Issue Date : 2024-05-23
Type : Chemical
Substance Number : 1750
Status : Valid
NDC Package Code : 46439-8729
Start Marketing Date : 2007-04-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R0-CEP 2013-158 - Rev 02
Issue Date : 2016-07-08
Type : Chemical
Substance Number : 1750
Status : Expired
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
NDC Package Code : 22552-0043
Start Marketing Date : 2015-01-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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DMF Review : Reviewed
Rev. Date : 2014-06-02
Pay. Date : 2013-03-11
DMF Number : 22980
Submission : 2009-07-22
Status : Active
Type : II
Certificate Number : R1-CEP 2007-262 - Rev 03
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1750
Status : Valid
Date of Issue : 2022-08-24
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
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NDC Package Code : 15308-0200
Start Marketing Date : 2005-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Details:
The acquisition of “Combihale” is expected to strengthen Mankind’s presence in the inhalation respiratory market segment. Daffy is a soap-free moisturising bar for infant babies.
Lead Product(s): Formoterol Fumarate,Fluticasone Propionate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Combihale
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Mankind Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 16, 2022
Lead Product(s) : Formoterol Fumarate,Fluticasone Propionate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Mankind Pharma
Deal Size : Undisclosed
Deal Type : Acquisition
Mankind Pharma to Acquire Combihale and Daffy Brands From Dr Reddy's Laboratories
Details : The acquisition of “Combihale” is expected to strengthen Mankind’s presence in the inhalation respiratory market segment. Daffy is a soap-free moisturising bar for infant babies.
Product Name : Combihale
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 16, 2022
Details:
Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Fluticasone Propionate/Salmeterol-Generic
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Hikma Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 21, 2021
Lead Product(s) : Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Vectura Highlights Update Made by Hikma on Launch of Generic Advair Diskus®
Details : Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Product Name : Fluticasone Propionate/Salmeterol-Generic
Product Type : Steroid
Upfront Cash : Inapplicable
April 21, 2021
Details:
The new device is an evolution of Vectura’s lever-operated multi-dose (LOMI) device and builds on Vectura and Hikma’s shared experience with the generic Advair Diskus® programme, enabling accelerated development under this agreement.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Fluticasone Propionate/Salmeterol-Generic
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Hikma Pharmaceuticals
Deal Size: $95.0 million Upfront Cash: $15.0 million
Deal Type: Agreement December 17, 2020
Lead Product(s) : Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : $95.0 million
Deal Type : Agreement
Vectura Earns $11m Milestone as Hikma Receives US FDA Approval for Generic Advair Diskus®
Details : The new device is an evolution of Vectura’s lever-operated multi-dose (LOMI) device and builds on Vectura and Hikma’s shared experience with the generic Advair Diskus® programme, enabling accelerated development under this agreement.
Product Name : Fluticasone Propionate/Salmeterol-Generic
Product Type : Steroid
Upfront Cash : $15.0 million
December 17, 2020
Details:
Fluticasone Propionate / Salmeterol or VR315 is a generic, inhaled combination therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Fluticasone Propionate/Salmeterol-Generic
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Hikma Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 22, 2020
Lead Product(s) : Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fluticasone Propionate / Salmeterol or VR315 is a generic, inhaled combination therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.
Product Name : Fluticasone Propionate/Salmeterol-Generic
Product Type : Steroid
Upfront Cash : Inapplicable
September 22, 2020
Details:
Through the acquisition, Paratek will add Xhance (fluticasone propionate) to its portfolio which is approved for the treatment of nasal polyps in patients 18 years of age or older.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xhance
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Paratek Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition May 21, 2025
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Paratek Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Paratek Finalizes Optinose Acquisition, Expands Specialty Therapy Portfolio
Details : Through the acquisition, Paratek will add Xhance (fluticasone propionate) to its portfolio which is approved for the treatment of nasal polyps in patients 18 years of age or older.
Product Name : Xhance
Product Type : Steroid
Upfront Cash : Undisclosed
May 21, 2025
Details:
EP-104GI (fluticasone propionate) is a corticosteroid acts on glucocorticoid receptor, currently being investigated for eosinophilic esophagitis.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Gastroenterology Brand Name: EP-104GI
Study Phase: Phase I/ Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 05, 2025
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eupraxia Shows Lasting Benefits for EoE After Nine Months of EP-104GI
Details : EP-104GI (fluticasone propionate) is a corticosteroid acts on glucocorticoid receptor, currently being investigated for eosinophilic esophagitis.
Product Name : EP-104GI
Product Type : Steroid
Upfront Cash : Inapplicable
May 05, 2025
Details:
Through the acquisition, Paratek will add Xhance (fluticasone propionate) to its portfolio which is approved for the treatment of nasal polyps in patients 18 years of age or older.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xhance
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Paratek Pharmaceuticals
Deal Size: $330.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition March 19, 2025
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Paratek Pharmaceuticals
Deal Size : $330.0 million
Deal Type : Acquisition
Paratek to Acquire Optinose, Expanding XHANCE® in Chronic Rhinosinusitis
Details : Through the acquisition, Paratek will add Xhance (fluticasone propionate) to its portfolio which is approved for the treatment of nasal polyps in patients 18 years of age or older.
Product Name : Xhance
Product Type : Steroid
Upfront Cash : Undisclosed
March 19, 2025
Details:
EP-104GI (fluticasone propionate) is a glucocorticoid receptor agonist which is being evaluated for the treatment for patients with eosinophilic esophagitis.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Gastroenterology Brand Name: EP-104GI
Study Phase: Phase I/ Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 25, 2025
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eupraxia Reports Positive Data in EP-104GI EoE Trial
Details : EP-104GI (fluticasone propionate) is a glucocorticoid receptor agonist which is being evaluated for the treatment for patients with eosinophilic esophagitis.
Product Name : EP-104GI
Product Type : Steroid
Upfront Cash : Inapplicable
February 25, 2025
Details:
EP-104GI (fluticasone propionate) is a glucocorticoid receptor agonist which is being evaluated for the treatment for patients with eosinophilic esophagitis.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Gastroenterology Brand Name: EP-104GI
Study Phase: Phase I/ Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 11, 2024
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eupraxia Announces Positive Data from Phase 1b/2a Trial of EP-104GI
Details : EP-104GI (fluticasone propionate) is a glucocorticoid receptor agonist which is being evaluated for the treatment for patients with eosinophilic esophagitis.
Product Name : EP-104GI
Product Type : Steroid
Upfront Cash : Inapplicable
December 11, 2024
Details:
EP-104GI (fluticasone propionate) is a glucocorticoid receptor agonist which is being evaluated for the treatment for patients with eosinophilic esophagitis.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Gastroenterology Brand Name: EP-104GI
Study Phase: Phase I/ Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 09, 2024
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eupraxia Shares Data from Phase 1b/2a Trial of EP-104GI for Eosinophilic Esophagitis
Details : EP-104GI (fluticasone propionate) is a glucocorticoid receptor agonist which is being evaluated for the treatment for patients with eosinophilic esophagitis.
Product Name : EP-104GI
Product Type : Steroid
Upfront Cash : Inapplicable
November 09, 2024
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Suspension, Tablet
Grade : Topical, Oral
Category : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : Carboxymethyl Cellulose
Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Carboxymethylcellulose serves as a disintegrant, binder, coating agent & thickener in oral formulations, also as a stabilizer in topical formulations.
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Grade : Oral
Category : Co-Processed Excipients, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Capsule, Injectable / Parenteral, Tablet
Grade : Oral, Parenteral
Category : Fillers, Diluents & Binders, Parenteral
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Dosage Form : Cream / Lotion / Ointment, Gel, Tablet
Grade : Oral, Topical
Category : Solubilizers, Topical
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Tablet
Grade : Oral, Topical
Category : Emulsifying Agents, Solubilizers, Thickeners and Stabilizers, Topical
Brand Name : Benzalkonium Chloride 17% USP NF
Application : Solubilizers
Excipient Details : A&C’s Benzalkonium Chloride 17% is a preservative which meets the NF monograph.
Pharmacopoeia Ref : USP NF
Technical Specs : 17% USP NF
Ingredient(s) : Benzalkonium chloride excipient
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Oral, Topical
Category : Emulsifying Agents, Solubilizers, Topical
Application : Emulsifying Agents, Solubilizers, Topical
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Pharmacopoeia Ref : USP/NF
Technical Specs : N/A
Ingredient(s) : Polyoxyl 40 Hydrogenated Castor Oil
Brand Name : Benzalkonium Chloride 50% NF
Application : Solubilizers
Excipient Details : A&C’s Benzalkonium Chloride 50% is a preservative which meets the NF monograph. It acts as a quarternary ammonium salt.
Dosage Form : Capsule, Cream / Lotion / Ointment, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers, Surfactant & Foaming Agents
Application : Solubilizers, Surfactant & Foaming Agents
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Dosage Form : Gel, Softgel Capsule, Solution, Suppository
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Nonionic solubilizer, emulsifier and co-emulsifier
Application : Solubilizers, Thickeners and Stabilizers
Excipient Details : It provides solubility and viscosity stability on medium viscosity.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Medium Viscosity
Ingredient(s) : Carboxymethyl cellulose sodium
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Paste, Shampoo, Solution, Syrup, Tablet
Grade : Topical, Oral
Category : Film Formers & Plasticizers, Solubilizers, Surfactant & Foaming Agents, Topical
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Film Formers & Plasticizers, Solubilizers, Surfactant & Foaming Agents, Topical
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Pharmacopoeia Ref : Ph.Eur, USP-NF
Technical Specs : HLB: 15, EO: 20; EXCiPACT
Ingredient(s) : Polysorbate 80
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
Grade : Topical, Parenteral
Category : Parenteral, Topical
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Dosage Form : Cream / Lotion / Ointment, Gel, Tablet
Grade : Oral, Topical
Category : Solubilizers, Topical
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Tablet
Grade : Oral, Topical
Category : Emulsifying Agents, Solubilizers, Thickeners and Stabilizers, Topical
Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Softgels, Tablet
Grade : Oral, Topical, Parenteral
Category : Film Formers & Plasticizers, Parenteral, Topical
Dosage Form : Emulsion
Grade : Topical
Category : Emulsifying Agents, Surfactant & Foaming Agents, Topical
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels
Grade : Parenteral, Oral, Topical
Category : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical
Dosage Form : Capsule, Cream / Lotion / Ointment
Grade : Topical and Oral
Category : Film Formers & Plasticizers, Topical
Application : Film Formers & Plasticizers, Topical
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Oral, Topical
Category : Emulsifying Agents, Solubilizers, Topical
Application : Emulsifying Agents, Solubilizers, Topical
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Pharmacopoeia Ref : USP/NF
Technical Specs : N/A
Ingredient(s) : Polyoxyl 40 Hydrogenated Castor Oil
Dosage Form : Capsule, Cream / Lotion / Ointment, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers, Surfactant & Foaming Agents
Application : Solubilizers, Surfactant & Foaming Agents
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
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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 Flovent HFA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flovent HFA, including repackagers and relabelers. The FDA regulates Flovent HFA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flovent HFA 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 Flovent HFA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flovent HFA supplier is an individual or a company that provides Flovent HFA active pharmaceutical ingredient (API) or Flovent HFA finished formulations upon request. The Flovent HFA suppliers may include Flovent HFA API manufacturers, exporters, distributors and traders.
click here to find a list of Flovent HFA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flovent HFA DMF (Drug Master File) is a document detailing the whole manufacturing process of Flovent HFA active pharmaceutical ingredient (API) in detail. Different forms of Flovent HFA DMFs exist exist since differing nations have different regulations, such as Flovent HFA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flovent HFA DMF submitted to regulatory agencies in the US is known as a USDMF. Flovent HFA USDMF includes data on Flovent HFA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flovent HFA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flovent HFA 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 Flovent HFA Drug Master File in Japan (Flovent HFA JDMF) empowers Flovent HFA 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 Flovent HFA JDMF during the approval evaluation for pharmaceutical products. At the time of Flovent HFA 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 Flovent HFA 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 Flovent HFA Drug Master File in Korea (Flovent HFA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flovent HFA. The MFDS reviews the Flovent HFA KDMF as part of the drug registration process and uses the information provided in the Flovent HFA KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flovent HFA 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 Flovent HFA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flovent HFA suppliers with KDMF on PharmaCompass.
A Flovent HFA CEP of the European Pharmacopoeia monograph is often referred to as a Flovent HFA Certificate of Suitability (COS). The purpose of a Flovent HFA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flovent HFA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flovent HFA to their clients by showing that a Flovent HFA CEP has been issued for it. The manufacturer submits a Flovent HFA CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flovent HFA CEP holder for the record. Additionally, the data presented in the Flovent HFA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flovent HFA DMF.
A Flovent HFA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flovent HFA 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 Flovent HFA suppliers with CEP (COS) on PharmaCompass.
A Flovent HFA written confirmation (Flovent HFA WC) is an official document issued by a regulatory agency to a Flovent HFA manufacturer, verifying that the manufacturing facility of a Flovent HFA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Flovent HFA APIs or Flovent HFA finished pharmaceutical products to another nation, regulatory agencies frequently require a Flovent HFA WC (written confirmation) as part of the regulatory process.
click here to find a list of Flovent HFA 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 Flovent HFA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flovent HFA 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 Flovent HFA 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 Flovent HFA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flovent HFA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flovent HFA suppliers with NDC on PharmaCompass.
Flovent HFA 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 Flovent HFA 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 Flovent HFA GMP manufacturer or Flovent HFA GMP API supplier for your needs.
A Flovent HFA CoA (Certificate of Analysis) is a formal document that attests to Flovent HFA's compliance with Flovent HFA specifications and serves as a tool for batch-level quality control.
Flovent HFA CoA mostly includes findings from lab analyses of a specific batch. For each Flovent HFA 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.
Flovent HFA may be tested according to a variety of international standards, such as European Pharmacopoeia (Flovent HFA EP), Flovent HFA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flovent HFA USP).