Synopsis
Synopsis
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JDMF
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VMF
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South Africa
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1. 6 Alpha-fluorodihydroxy-16 Alpha,17 Alpha-isopropylidenedioxy-1,4-pregnadiene-3,20- Dione
2. 6alpha-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione Cyclic 16, 17-acetal With Acetone
3. Aerobid
4. Aerospan
5. Apo-flunisolide
6. Flunisolide 21-acetate
7. Flunisolide Acetate
8. Flunisolide Anhydrous
9. Flunisolide Hemihydrate
10. Flunisolide Hemihydrate, (6alpha,11beta,16alpha)-isomer
11. Flunisolide Hfa
12. Flunisolide Hydrofluoroalkane
13. Flunisolide, (6beta,11beta,16alpha)-isomer
14. Inhacort
15. Nasalide
16. Nasarel
17. Ratio-flunisolide
18. Rhinalar
19. Rs-1320
20. Rs-3999
21. Rs1320
22. Syntaris
1. 3385-03-3
2. Aerobid
3. Rhinalar
4. Synaclyn
5. Flunisolide Anhydrous
6. Nasarel
7. Syntaris
8. Flunisolide Hfa
9. Nasalide
10. Aerospan
11. Bronalide
12. Flunisolide [inn]
13. Flunisolida
14. Flunisolidum
15. Aerospan Hfa
16. Lunis
17. Rs-3999
18. Chebi:5106
19. Flunisolide Hemihydrate
20. Nisolid
21. Soluzione
22. Mls002153928
23. 78m02aa8kf
24. Pregna-1,4-diene-3,20-dione,6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6a,11b,16a)-
25. Aerobid M
26. Dsstox_cid_25534
27. Dsstox_rid_80936
28. Dsstox_gsid_45534
29. (1s,2s,4r,8s,9s,11s,12s,13r,19s)-19-fluoro-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one
30. Flunisolide [anhydrous]
31. Cas-3385-03-3
32. Nsc-757871
33. Flunisolidum [inn-latin]
34. Flunisolida [inn-spanish]
35. Syntaris Hayfever
36. Ncgc00016983-01
37. Lunisolide Anhydrous
38. Prestwick_223
39. Einecs 222-193-2
40. Rs 3999
41. Flunisolide [mi]
42. Prestwick0_000643
43. Prestwick1_000643
44. Prestwick2_000643
45. Prestwick3_000643
46. Schembl4351
47. Chembl1512
48. Unii-78m02aa8kf
49. Bspbio_000645
50. Flunisolide [who-dd]
51. 6alpha-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione Cyclic 16, 17-acetal With Acetone
52. Spbio_002566
53. Bpbio1_000711
54. Gtpl7076
55. Dtxsid1045534
56. Hms1570a07
57. Hms2097a07
58. Hms2236a06
59. Hms3259l10
60. Hms3714a07
61. Hy-b1121
62. Zinc4097305
63. Tox21_110725
64. Bdbm50248007
65. Akos025402038
66. Tox21_110725_1
67. Ac-3514
68. Bcp9000696
69. Ccg-220643
70. Cs-4713
71. Db00180
72. Nc00716
73. 6-fluoro-11,21-dihydroxy-16,17-(isopropylidenedioxy)pregna-1,4-diene-3,20-dione
74. Ncgc00179492-01
75. Ncgc00179492-03
76. Pregna-1,4-diene-3,20-dione, 6-alpha-fluoro-11-beta,16-alpha,17,21-tetrahydroxy-, Cyclic 16,17-acetal With Acetone
77. Pregna-1,4-diene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (6alpha,11beta,16alpha)-
78. Smr001233272
79. Flunisolide 100 Microg/ml In Acetonitrile
80. F0437
81. (6a,11b,16a)-6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione
82. C07005
83. D78324
84. 385f033
85. Q3746835
86. Brd-k49577446-001-03-1
87. (1s,2s,4r,8s,9s,11s,12s,13r,19s)-19-fluoro-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.0^{2,9}.0^{4,8}.0^{13,18}]icosa-14,17-dien-16-one
88. 6.alpha.-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxypregna-1,4-diene-3,20-dione Cyclic 16,17-acetal With Acetone
89. 6alpha-fluoro-11beta,21-dihydroxy-16alpha,17alpha-(isopropylidenedioxy)pregna-1,4-diene-3,20-dione
90. Pregna-1,4-diene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))- (6.alpha.,11.beta.,16.alpha.)-
Molecular Weight | 434.5 g/mol |
---|---|
Molecular Formula | C24H31FO6 |
XLogP3 | 2.5 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 2 |
Exact Mass | 434.21046687 g/mol |
Monoisotopic Mass | 434.21046687 g/mol |
Topological Polar Surface Area | 93.1 Ų |
Heavy Atom Count | 31 |
Formal Charge | 0 |
Complexity | 910 |
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 4 | |
---|---|
Drug Name | Aerospan hfa |
PubMed Health | Flunisolide |
Drug Classes | Anti-Inflammatory |
Drug Label | Flunisolide hemihydrate, the active component of AEROSPANTM (flunisolide HFA, 80 mcg) Inhalation Aerosol, is a corticosteroid having the chemical name 6-Fluoro-11, 16, 17, 21 tetrahydroxylpregna-1, 4-diene-3, 20-dione cyclic-16, 17-acetal wi... |
Active Ingredient | Flunisolide |
Dosage Form | Aerosol, metered |
Route | Inhalation |
Strength | 0.078mg/inh |
Market Status | Prescription |
Company | Meda Pharms |
2 of 4 | |
---|---|
Drug Name | Flunisolide |
Active Ingredient | Flunisolide |
Dosage Form | Spray, metered |
Route | Nasal |
Strength | 0.025mg/spray; 0.029mg/spray |
Market Status | Prescription |
Company | Apotex; Hi Tech Pharma; Bausch And Lomb |
3 of 4 | |
---|---|
Drug Name | Aerospan hfa |
PubMed Health | Flunisolide |
Drug Classes | Anti-Inflammatory |
Drug Label | Flunisolide hemihydrate, the active component of AEROSPANTM (flunisolide HFA, 80 mcg) Inhalation Aerosol, is a corticosteroid having the chemical name 6-Fluoro-11, 16, 17, 21 tetrahydroxylpregna-1, 4-diene-3, 20-dione cyclic-16, 17-acetal wi... |
Active Ingredient | Flunisolide |
Dosage Form | Aerosol, metered |
Route | Inhalation |
Strength | 0.078mg/inh |
Market Status | Prescription |
Company | Meda Pharms |
4 of 4 | |
---|---|
Drug Name | Flunisolide |
Active Ingredient | Flunisolide |
Dosage Form | Spray, metered |
Route | Nasal |
Strength | 0.025mg/spray; 0.029mg/spray |
Market Status | Prescription |
Company | Apotex; Hi Tech Pharma; Bausch And Lomb |
For the maintenance treatment of asthma as a prophylactic therapy.
FDA Label
Flunisolide is a synthetic corticosteroid. It is administered either as an oral metered-dose inhaler for the treatment of asthma or as a nasal spray for treating allergic rhinitis. Corticosteroids are naturally occurring hormones that prevent or suppress inflammation and immune responses. When given as an intranasal spray, flunisolide reduces watery nasal discharge (rhinorrhea), nasal congestion, postnasal drip, sneezing, and itching oat the back of the throat that are common allergic symptoms.
Anti-Asthmatic Agents
Drugs that are used to treat asthma. (See all compounds classified as Anti-Asthmatic Agents.)
Anti-Inflammatory Agents
Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)
R - Respiratory system
R01 - Nasal preparations
R01A - Decongestants and other nasal preparations for topical use
R01AD - Corticosteroids
R01AD04 - Flunisolide
R - Respiratory system
R03 - Drugs for obstructive airway diseases
R03B - Other drugs for obstructive airway diseases, inhalants
R03BA - Glucocorticoids
R03BA03 - Flunisolide
Absorption
Absorbed rapidly
Primarily hepatic, converted to the S beta-OH metabolite.
1.8 hours
Flunisolide is a glucocorticoid receptor agonist. The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding. Flunisolide binds to plasma transcortin, and it becomes active when it is not bound to transcortin.
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PharmaCompass offers a list of Flunisolide 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 Flunisolide manufacturer or Flunisolide supplier for your needs.
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A Syntaris manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Syntaris, including repackagers and relabelers. The FDA regulates Syntaris manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Syntaris 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 Syntaris manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Syntaris supplier is an individual or a company that provides Syntaris active pharmaceutical ingredient (API) or Syntaris finished formulations upon request. The Syntaris suppliers may include Syntaris API manufacturers, exporters, distributors and traders.
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A Syntaris DMF (Drug Master File) is a document detailing the whole manufacturing process of Syntaris active pharmaceutical ingredient (API) in detail. Different forms of Syntaris DMFs exist exist since differing nations have different regulations, such as Syntaris USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Syntaris DMF submitted to regulatory agencies in the US is known as a USDMF. Syntaris USDMF includes data on Syntaris's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Syntaris USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Syntaris as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Syntaris 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 Syntaris 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 Syntaris and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Syntaris NDC to their finished compounded human drug products, they may choose to do so.
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Syntaris 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).
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A Syntaris CoA (Certificate of Analysis) is a formal document that attests to Syntaris's compliance with Syntaris specifications and serves as a tool for batch-level quality control.
Syntaris CoA mostly includes findings from lab analyses of a specific batch. For each Syntaris 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.
Syntaris may be tested according to a variety of international standards, such as European Pharmacopoeia (Syntaris EP), Syntaris JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Syntaris USP).