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1. Asmanex
2. Asmanex Twisthaler
3. Elocon
4. Furoate Monohydrate, Mometasone
5. Furoate, Mometasone
6. Mometasone
7. Mometasone Furoate Monohydrate
8. Monohydrate, Mometasone Furoate
9. Nasonex
10. Rinelon
11. Sch 32088
12. Sch-32088
13. Sch32088
14. Twisthaler, Asmanex
1. 83919-23-7
2. Asmanex
3. Nasonex
4. Elocon
5. Monovo
6. Sch 32088
7. Mometasone 17-furoate
8. Sinuva
9. Mometasone Furoate Anhydrous
10. Sch32088
11. Sch-32088
12. Nsc-746171
13. Chembl1161
14. Lyr210
15. (8s,9r,10s,11s,13s,14s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl Furan-2-carboxylate
16. [(8s,9r,10s,11s,13s,14s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate
17. Chebi:47564
18. Lyr-210
19. 04201gdn4r
20. Nsc-760077
21. (11beta,16alpha)-9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methylpregna-1,4-diene-3,20-dione
22. Danitin
23. Ecural
24. Elomet
25. Dsstox_cid_3333
26. Asmanex Twisthaler
27. Dsstox_rid_76981
28. Dsstox_gsid_23333
29. (9beta,10alpha,11alpha,14beta,16alpha,17alpha)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl Furan-2-carboxylate
30. 9,21-dichloro-11beta-hydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-17-yl Furan-2-carboxylate
31. Elocone
32. Flumeta
33. Nosorex
34. Rimelon
35. Ovixan
36. Asmanex Hfa
37. Mometasone Fuorate
38. Mof
39. Unii-04201gdn4r
40. Mometasone-furoate
41. Ncgc00016950-01
42. Prestwick_924
43. Asmanex (tn)
44. Mometasone Furoate [usan:usp:jan]
45. Cas-83919-23-7
46. Elocon (tn)
47. Las 41002
48. Brn 4340538
49. Prestwick0_000572
50. Prestwick1_000572
51. Prestwick2_000572
52. Prestwick3_000572
53. Mometasone Furancarboxylate
54. Schembl4568
55. Bspbio_000384
56. Mometasone 17-(2-furoate)
57. Mls002153879
58. Spbio_002603
59. Mometasone Furoate (jan/usp)
60. Bpbio1_000424
61. Mometasone Furoate [mi]
62. Dtxsid4023333
63. Mometasone Furoate [jan]
64. Mometasone Furoate [usan]
65. Hms1569d06
66. Hms2096d06
67. Hms2235i14
68. Hms3713d06
69. Mometasone Furoate [vandf]
70. Mometasone Furoate [mart.]
71. Mometasone Furoate [usp-rs]
72. Mometasone Furoate [who-dd]
73. Zinc3938677
74. Tox21_110705
75. Ac-941
76. Bdbm50148733
77. Mfcd00866003
78. Nsc746171
79. S1987
80. Mometasone Furoate, >=98% (hplc)
81. Akos015994732
82. Tox21_110705_1
83. Ccg-220572
84. Db14512
85. Ks-1275
86. Mometasone Furoate [green Book]
87. Nsc 746171
88. Nsc 760077
89. 9,21-dichloro-11beta,17-dihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 17-(2-furoate)
90. Mometasone Furoate [orange Book]
91. Mometasone Furoate [ep Monograph]
92. Ncgc00179578-01
93. Ncgc00179578-03
94. Ncgc00179578-04
95. (11beta,16alpha)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl Furan-2-carboxylate
96. Dulera Component Mometasone Furoate
97. Hy-13693
98. Mometasone Furoate [usp Monograph]
99. Smr001233233
100. M2354
101. Mometasone Furoate Component Of Dulera
102. C07817
103. D00690
104. Mometasone Furoate 1000 Microg/ml In Methanol
105. 919m237
106. A840685
107. Mometasone Furoate 100 Microg/ml In Acetonitrile
108. Sr-01000841209
109. Lyr-220 Active Component Mometasone Furoate
110. Q-101380
111. Q1044248
112. Sr-01000841209-2
113. Brd-k60640630-001-03-7
114. Brd-k60640630-001-11-0
115. Mometasone Furoate, European Pharmacopoeia (ep) Reference Standard
116. Mometasone Furoate, United States Pharmacopeia (usp) Reference Standard
117. 11?,16?)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl 2-furoate
118. Mometasone Furoate, Pharmaceutical Secondary Standard; Certified Reference Material
119. (11.beta.,16.alpha.)-9,21-dichloro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methylpregna-1,4-diene-3,20-dione
120. [(8s,9r,10s,11s,13s,14s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate;mometasone Furoate
121. [(9r,10s,11s,13s,16r,17r)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate
122. 9,21-dichloro-11.beta.,17-dihydroxy-16.alpha.-methylpregna-1,4-diene-3,20-dione 17-(2-furoate)
123. Pregna-1,20-dione, 9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-, (11.beta.,16.alpha.)-
124. Pregna-1,4-diene-3,20-dione, 9,21-dichloro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methyl-, (11.beta.,16.alpha.)
125. Pregna-1,4-diene-3,20-dione, 9,21-dichloro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methyl-, (11beta,16alpha)-
Molecular Weight | 521.4 g/mol |
---|---|
Molecular Formula | C27H30Cl2O6 |
XLogP3 | 3.9 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 5 |
Exact Mass | 520.1419441 g/mol |
Monoisotopic Mass | 520.1419441 g/mol |
Topological Polar Surface Area | 93.8 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 1020 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 8 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 6 | |
---|---|
Drug Name | Elocon |
Drug Label | ELOCON (mometasone furoate) Ointment, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.Chemically, mometasone furoate is 9,21-dichloro-11,17-dihydroxy-16-methylpr... |
Active Ingredient | Mometasone furoate |
Dosage Form | Lotion; Ointment; Cream |
Route | Topical |
Strength | 0.1% |
Market Status | Prescription |
Company | Merck Sharp Dohme |
2 of 6 | |
---|---|
Drug Name | Mometasone furoate |
PubMed Health | Mometasone |
Drug Classes | Anti-Inflammatory, Corticosteroid, Strong |
Drug Label | Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure... |
Active Ingredient | Mometasone furoate |
Dosage Form | Ointment; Cream; Lotion |
Route | Topical |
Strength | 0.1% |
Market Status | Prescription |
Company | Taro; Glenmark Generics; Fougera Pharms; Perrigo; Perrigo New York; Tolmar; G And W Labs |
3 of 6 | |
---|---|
Drug Name | Nasonex |
Drug Label | Mometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, an... |
Active Ingredient | Mometasone furoate monohydrate |
Dosage Form | Spray, metered |
Route | Nasal |
Strength | eq 0.05mg base/spray |
Market Status | Prescription |
Company | Merck Sharp Dohme |
4 of 6 | |
---|---|
Drug Name | Elocon |
Drug Label | ELOCON (mometasone furoate) Ointment, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.Chemically, mometasone furoate is 9,21-dichloro-11,17-dihydroxy-16-methylpr... |
Active Ingredient | Mometasone furoate |
Dosage Form | Lotion; Ointment; Cream |
Route | Topical |
Strength | 0.1% |
Market Status | Prescription |
Company | Merck Sharp Dohme |
5 of 6 | |
---|---|
Drug Name | Mometasone furoate |
PubMed Health | Mometasone |
Drug Classes | Anti-Inflammatory, Corticosteroid, Strong |
Drug Label | Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure... |
Active Ingredient | Mometasone furoate |
Dosage Form | Ointment; Cream; Lotion |
Route | Topical |
Strength | 0.1% |
Market Status | Prescription |
Company | Taro; Glenmark Generics; Fougera Pharms; Perrigo; Perrigo New York; Tolmar; G And W Labs |
6 of 6 | |
---|---|
Drug Name | Nasonex |
Drug Label | Mometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, an... |
Active Ingredient | Mometasone furoate monohydrate |
Dosage Form | Spray, metered |
Route | Nasal |
Strength | eq 0.05mg base/spray |
Market Status | Prescription |
Company | Merck Sharp Dohme |
There are 3 formulations of mometasone furoate with various indications. The inhaler is indicated for prophylaxis of asthma in patients 4 years. The nasal spray is indicated for treating nasal symptoms of allergic rhinitis in patients 2 years, treating symptoms of nasal congestion from seasonal allergic rhinitis in patients 2 years, treating nasal polyps in patients 18 years, and prophylaxis of seasonal allergic rhinitis in patients 12 years. The ointment is indicated for symptomatic treatment of dermatitis and pruritis in patients 2 years.
FDA Label
Seasonal and perennial allergic rhinitis
Mometasone is a synthetic corticosteroid with an affinity for glucocorticoid receptors 22 times higher than that of [dexamethasone]. Mometasone furoate also has a lower affinity to mineralocorticoid receptors than natural corticosteroids, making it more selective in its action. Mometasone furoate diffuses across cell membranes to activate pathways responsible for reducing inflammation.
Anti-Inflammatory Agents
Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory 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.)
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.)
Absorption
The mean time to peak concentration is 1.0 to 2.5 hours. Bioavailability has been reported as <1% but studies of repeat doses of inhaled corticosteroids suggest a bioavailability of 11%. The 0.1% ointment may have a bioavailability of 0.7%.
Route of Elimination
For an inhaled dose, approximately 74% is excreted in the feces and 8% is excreted in the urine.
Volume of Distribution
Steady state volume of distribution of 152L.
Clearance
The clearance rate of mometasone furoate is not readily available, though it may be close to 90L/h.
Metabolism of mometasone furoate is largely performed hepatically by cytochrome P450 3A4 producing a number of metabolites. Some of these metabolites include free mometasone and 6-beta-hydroxy-mometasone furoate.
The terminal half life of an inhaled dose is approximately 5 hours though it has been reported as 5.8 hours by other sources.
In asthma, mometasone is believed to inhibit mast cells, eosinophils, basophils, and lymphocytes. There is also evidence of inhibition of histamine, leukotrienes, and cytokines. Corticosteroids diffuse across cell membranes into the cytosol of cells where they bind to glucocorticoid receptors to produce their activity. Mometasone furoate has a particularly high receptor affinity compare to other corticosteroids, 22 times higher than that of [dexamethasone]. Mometasone furoate binding to a glucocorticoid receptor causes conformational changes in the receptor, separation from chaperones, and the receptor moves to the nucleus. Once at the nucleus, receptors dimerize and bind to a DNA sequence known as the glucocorticoid response element which either increases expression of anti-inflammatory molecules or inhibits expression of pro-inflammatory molecules (such as interleukins 4 and 5). Mometasone furoate also reduces inflammation by blocking transcription factors such as activator-protein-1 and nuclear factor kappa B (NF-kappaB).
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-01
Pay. Date : 2014-04-29
DMF Number : 20684
Submission : 2007-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25448
Submission : 2011-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35686
Submission : 2021-07-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31076
Submission : 2016-11-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30852
Submission : 2016-09-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-09
Pay. Date : 2019-09-18
DMF Number : 33446
Submission : 2019-03-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2014-03-20
DMF Number : 22319
Submission : 2008-12-18
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-25
Pay. Date : 2013-02-14
DMF Number : 23888
Submission : 2010-06-08
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15187
Submission : 2000-12-07
Status : Active
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23977
Submission : 2010-07-14
Status : Active
Type : II
Mometasone Furoate, Micronised
Certificate Number : R1-CEP 2007-194 - Rev 03
Status : Valid
Issue Date : 2022-08-26
Type : Chemical
Substance Number : 1449
Mometasone Furoate Monohydrate, Micronised
Certificate Number : CEP 2024-282 - Rev 00
Status : Valid
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 2858
Certificate Number : R0-CEP 2022-081 - Rev 00
Status : Valid
Issue Date : 2023-05-26
Type : Chemical
Substance Number : 1449
Mometasone Furoate, Micronised
Certificate Number : R1-CEP 2012-111 - Rev 00
Status : Valid
Issue Date : 2018-08-27
Type : Chemical
Substance Number : 1449
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Mometasone Furoate Monohydrate
Certificate Number : R0-CEP 2021-233 - Rev 01
Status : Valid
Issue Date : 2023-01-18
Type : Chemical
Substance Number : 2858
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R1-CEP 2007-302 - Rev 03
Status : Valid
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1449
Certificate Number : R1-CEP 2007-112 - Rev 03
Status : Valid
Issue Date : 2019-08-16
Type : Chemical
Substance Number : 1449
Certificate Number : R1-CEP 2005-163 - Rev 02
Status : Valid
Issue Date : 2021-08-24
Type : Chemical
Substance Number : 1449
Certificate Number : R1-CEP 2004-111 - Rev 02
Status : Valid
Issue Date : 2021-10-29
Type : Chemical
Substance Number : 1449
Certificate Number : R0-CEP 2019-268 - Rev 00
Status : Valid
Issue Date : 2021-11-08
Type : Chemical
Substance Number : 1449
Mometasone Furoate BP/EP/USP/IP; Mometasone Furoate Monohydrate IH/EP
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm : Plot No. 55, 56 & 57, HSIIDC Industrial Estate, Murthal, Sonipat 131029, Haryana
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Mometasone Furoate BP/USP/IH/EP
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm : Plot No. E-50, 50/1 and 59/1, Unit — IV, MIDC, Tarapur — 401506, Taluka: Pal...
Mometasone Furoate Monohydrate (EP)
Date of Issue : 2022-12-09
Valid Till : 2025-07-02
Written Confirmation Number : WC-0169
Address of the Firm : A-1/7, 1st Phase GIDC, Vapi-396 195, Valsad, Gujarat, India
Date of Issue : 2022-06-08
Valid Till : 2025-09-08
Written Confirmation Number : WC-0144nA2
Address of the Firm : D-7, MIDC, Industrial Area, Kurkumbh, Taluka: Daund, District: Pune -Zone4- 413 ...
Mometasone Furoate (BP/EP/USP)
Date of Issue : 2022-06-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-247
Address of the Firm : Plot No D-5/8, D-5/9, MIDC Turbhe,\r\nMumbai-400703, Maharashtra, India\r\n
Date of Issue : 2022-08-04
Valid Till : 2025-07-02
Written Confirmation Number : WC-241
Address of the Firm : Plot No. 409, Phase-IV, GIDC Industrial Estate, Naroda, Ahemdabad-382330, Gujara...
Date of Issue : 2020-09-25
Valid Till : 2023-09-24
Written Confirmation Number : WC-0485
Address of the Firm : Block No 203, Vaso-Alindra Road, PO Alindra-387510, Tal-Matar Dist. Kheda, Gujar...
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
Mometasone Furoate Monohydrate
About the Company : A research-based international pharmaceutical company, Coral Drugs has more than 27 years of expertise in manufacturing a wide variety of high-quality and affordable active pharmac...
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international ma...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
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Details:
QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 07, 2020
Lead Product(s) : Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
QVM149 Receives Regulatory Approval in Europe and Japan
Details : QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.
Product Name : Enerzair Breezhaler
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 07, 2020
Details:
LYR-210 (mometasone furoate) is a glucocorticoid receptor agonist. It is being evaluated as an anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Infections and Infectious Diseases Brand Name: LYR-210
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 15, 2024
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lyra Therapeutics Completes Enrollment in Phase 3 Trial for Chronic Rhinosinusitis
Details : LYR-210 (mometasone furoate) is a glucocorticoid receptor agonist. It is being evaluated as an anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis.
Product Name : LYR-210
Product Type : Steroid
Upfront Cash : Inapplicable
October 15, 2024
Details:
LYR-210 (mometasone furoate) is a glucocorticoid receptor agonist. It is being evaluated as an anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Infections and Infectious Diseases Brand Name: LYR-210
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 05, 2024
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lyra Therapeutics Reports Topline Results from Phase 3 ENLIGHTEN 1 Trial for LYR-210
Details : LYR-210 (mometasone furoate) is a glucocorticoid receptor agonist. It is being evaluated as an anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis.
Product Name : LYR-210
Product Type : Steroid
Upfront Cash : Inapplicable
June 05, 2024
Details:
Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Immunology Brand Name: Nasonex-Generic
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 19, 2024
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Receives USFDA Approval for Mometasone Furoate Nasal Spray
Details : Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.
Product Name : Nasonex-Generic
Product Type : Steroid
Upfront Cash : Inapplicable
March 19, 2024
Details:
LYR-220 (mometasone furoate) is a bioresorbable, polymetric matrix that is designed to deliver six months of continuous anti-inflammatory medication (7500µg MF) to the sinonasal passages for the treatment of CRS.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Infections and Infectious Diseases Brand Name: LYR-220
Study Phase: Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 09, 2023
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : LYR-220 (mometasone furoate) is a bioresorbable, polymetric matrix that is designed to deliver six months of continuous anti-inflammatory medication (7500µg MF) to the sinonasal passages for the treatment of CRS.
Product Name : LYR-220
Product Type : Steroid
Upfront Cash : Inapplicable
December 09, 2023
Details:
LYR-210 (mometasone furoate) is a bioresorbable nasal implant which is intended to deliver up to six months of continuous, proven anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat chronic rhinosinusitis (CRS).
Lead Product(s): Mometasone Furoate
Therapeutic Area: Infections and Infectious Diseases Brand Name: LYR-210
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 29, 2023
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : LYR-210 (mometasone furoate) is a bioresorbable nasal implant which is intended to deliver up to six months of continuous, proven anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat chronic rhinosinusitis (CRS).
Product Name : LYR-210
Product Type : Steroid
Upfront Cash : Inapplicable
August 29, 2023
Details:
LYR-220 (mometasone furoate) is a bioresorbable, polymetric matrix that is designed to deliver six months of continuous anti-inflammatory medication (7500µg MF) to the sinonasal passages for the treatment of CRS.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Infections and Infectious Diseases Brand Name: LYR-220
Study Phase: Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 02, 2023
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : LYR-220 (mometasone furoate) is a bioresorbable, polymetric matrix that is designed to deliver six months of continuous anti-inflammatory medication (7500µg MF) to the sinonasal passages for the treatment of CRS.
Product Name : LYR-220
Product Type : Steroid
Upfront Cash : Inapplicable
June 02, 2023
Details:
ESO-101 (mometasone furoate), designed as a locoregional, esophagus-adjusted drug formulation and novel delivery system to optimize mucosal contact time and maximize esophageal deposition, has the potential to provide significant clinical benefits to eosinophilic esophagitis.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Gastroenterology Brand Name: ESO-101
Study Phase: Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 12, 2023
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ESO-101 (mometasone furoate), designed as a locoregional, esophagus-adjusted drug formulation and novel delivery system to optimize mucosal contact time and maximize esophageal deposition, has the potential to provide significant clinical benefits to eos...
Product Name : ESO-101
Product Type : Steroid
Upfront Cash : Inapplicable
May 12, 2023
Details:
ESO-101 was designed as a locoregional, esophagus-adjusted drug formulation and novel delivery system to optimize mucosal contact time and maximize esophageal deposition of mometasone furoate. it has the potential to provide significant clinical benefits to EoE patients.
Lead Product(s): Mometasone Furoate
Therapeutic Area: Gastroenterology Brand Name: ESO-101
Study Phase: Phase IIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2023
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EsoCap Completes Patient Recruitment in ACESO Phase II Trial in Eosinophilic Esophagitis
Details : ESO-101 was designed as a locoregional, esophagus-adjusted drug formulation and novel delivery system to optimize mucosal contact time and maximize esophageal deposition of mometasone furoate. it has the potential to provide significant clinical benefits...
Product Name : ESO-101
Product Type : Steroid
Upfront Cash : Inapplicable
May 09, 2023
Details:
LYR-210 is a bioresorbable nasal implant which is intended to deliver up to six months of continuous, proven anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat chronic rhinosinusitis (CRS).
Lead Product(s): Mometasone Furoate
Therapeutic Area: Infections and Infectious Diseases Brand Name: LYR-210
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 25, 2023
Lead Product(s) : Mometasone Furoate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : LYR-210 is a bioresorbable nasal implant which is intended to deliver up to six months of continuous, proven anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat chronic rhinosinusitis (CRS).
Product Name : LYR-210
Product Type : Steroid
Upfront Cash : Inapplicable
April 25, 2023
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PharmaCompass offers a list of Mometasone Furoate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mometasone Furoate manufacturer or Mometasone Furoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mometasone Furoate manufacturer or Mometasone Furoate supplier.
PharmaCompass also assists you with knowing the Mometasone Furoate API Price utilized in the formulation of products. Mometasone Furoate API Price is not always fixed or binding as the Mometasone Furoate Price is obtained through a variety of data sources. The Mometasone Furoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rimelon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimelon, including repackagers and relabelers. The FDA regulates Rimelon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimelon 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 Rimelon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rimelon supplier is an individual or a company that provides Rimelon active pharmaceutical ingredient (API) or Rimelon finished formulations upon request. The Rimelon suppliers may include Rimelon API manufacturers, exporters, distributors and traders.
click here to find a list of Rimelon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rimelon DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimelon active pharmaceutical ingredient (API) in detail. Different forms of Rimelon DMFs exist exist since differing nations have different regulations, such as Rimelon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimelon DMF submitted to regulatory agencies in the US is known as a USDMF. Rimelon USDMF includes data on Rimelon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimelon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimelon 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 Rimelon Drug Master File in Japan (Rimelon JDMF) empowers Rimelon 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 Rimelon JDMF during the approval evaluation for pharmaceutical products. At the time of Rimelon 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 Rimelon 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 Rimelon Drug Master File in Korea (Rimelon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rimelon. The MFDS reviews the Rimelon KDMF as part of the drug registration process and uses the information provided in the Rimelon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rimelon 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 Rimelon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rimelon suppliers with KDMF on PharmaCompass.
A Rimelon CEP of the European Pharmacopoeia monograph is often referred to as a Rimelon Certificate of Suitability (COS). The purpose of a Rimelon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rimelon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rimelon to their clients by showing that a Rimelon CEP has been issued for it. The manufacturer submits a Rimelon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rimelon CEP holder for the record. Additionally, the data presented in the Rimelon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rimelon DMF.
A Rimelon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rimelon 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 Rimelon suppliers with CEP (COS) on PharmaCompass.
A Rimelon written confirmation (Rimelon WC) is an official document issued by a regulatory agency to a Rimelon manufacturer, verifying that the manufacturing facility of a Rimelon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rimelon APIs or Rimelon finished pharmaceutical products to another nation, regulatory agencies frequently require a Rimelon WC (written confirmation) as part of the regulatory process.
click here to find a list of Rimelon 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 Rimelon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rimelon 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 Rimelon 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 Rimelon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rimelon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rimelon suppliers with NDC on PharmaCompass.
Rimelon 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 Rimelon 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 Rimelon GMP manufacturer or Rimelon GMP API supplier for your needs.
A Rimelon CoA (Certificate of Analysis) is a formal document that attests to Rimelon's compliance with Rimelon specifications and serves as a tool for batch-level quality control.
Rimelon CoA mostly includes findings from lab analyses of a specific batch. For each Rimelon 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.
Rimelon may be tested according to a variety of international standards, such as European Pharmacopoeia (Rimelon EP), Rimelon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rimelon USP).