Synopsis
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1. Decadron Phosphate
2. Dexamethasone 21-phosphate
3. Dexamethasone 21-phosphate, (6alpha,11beta,16alpha)-isomer
4. Dexamethasone 21-phosphate, Copper (+2) Salt (2:3), (11beta,16alpha)-isomer
5. Dexamethasone 21-phosphate, Disodium Salt, (11beta,16alpha)-isomer
6. Dexamethasone 21-phosphate, Disodium Salt, (6alpha,11beta,16alpha)-isomer
7. Dexamethasone 21-phosphate, Monosodium Salt, (11beta,16alpha)-isomer
8. Dexamethasone 21-phosphate, Sodium Salt, (11beta,16alpha)-isomer
9. Dexamethasone Phosphate
10. Dexamethasone Phosphate Disodium Salt
11. Dexamethasonedisodium Phosphate
12. Solu- Decadron
13. Spersadex
14. Spersadox
1. 2392-39-4
2. Dexamethasone 21-phosphate Disodium Salt
3. Dalalone
4. Dexadreson
5. Dexamethasone Disodium Phosphate
6. Megacort
7. Soldesam
8. Dexagro
9. 55203-24-2
10. Decadron Phosphate
11. Dexabene
12. Orgadrone
13. Ak-dex
14. Sodium Dexamethasone Phosphate
15. Dexamethasone 21-(disodium Phosphate)
16. Dexamethasone Phosphate Disodium
17. 2392-39-4 (disodium)
18. Chebi:4462
19. Tlc399
20. Tlc-399
21. Ai9376y64p
22. Nsc-756722
23. Disodium;[2-[(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Phosphate
24. Spersadox
25. Decdan
26. Solu-decadron
27. Maxidex Ointment
28. Dsstox_cid_27429
29. Dsstox_rid_82342
30. Dsstox_gsid_47429
31. Hexadrol Injectable
32. Disodium [2-[(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Phosphate
33. Colvasone
34. Dexagel
35. Onadron
36. Baldex
37. Mfcd00079105
38. Dexaject Sp
39. Egp 437
40. Sodium 2-((8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-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)-2-oxoethyl Phosphate
41. Cas-2392-39-4
42. Disodium Dexamethasone Phosphate
43. 21-disodium Phosphate Dexamethasone
44. Einecs 219-243-0
45. Dexamethasone-21-phosphate Disodium Salt
46. Dexamethazone Sodium Phosphate
47. Unii-ai9376y64p
48. Ncgc00094644-01
49. Dalalone (tn)
50. Mephamesone
51. Soludecadron
52. Totocortin
53. Solupen N
54. Egp437. Dex-phos
55. Dexamethasone Sodium Phosphate [usp:ban:jan]
56. Schembl7778
57. Decadron Inhalation, Injection, Ophthalmic Solution And Ointment, And Topical Cream
58. 9-fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen Phosphate) Disodium Salt
59. Chembl2021430
60. Dtxsid3047429
61. Dexamethasone Phosphate Sodium Salt
62. Bcp16805
63. Tox21_113181
64. Tox21_302586
65. S4028
66. Akos015896357
67. Akos015951212
68. Am84812
69. Ccg-269820
70. Ks-1150
71. Nsc 756722
72. Ncgc00256783-01
73. Ac-17992
74. Dexamethasone Sodium Phosphate (jan/usp)
75. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, Disodium Salt, (11.beta.,16.alpha.)-
76. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, Disodium Salt, (11beta,16alpha)-
77. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-, 21-(dihydrogen Phosphate) Disodium Salt
78. Dexamethasone Phosphate (as Sodium)
79. Dexamethasone Sodium Phosphate [jan]
80. B1588
81. Dexamethasone Sodium Phosphate [mart.]
82. Dexamethasone Sodium Phosphate [vandf]
83. En300-52795
84. C08175
85. D00975
86. Dexamethasone Sodium Phosphate [usp-rs]
87. Dexamethasone Sodium Phosphate [who-dd]
88. Dexamethasone Sodium Phosphate [who-ip]
89. A816989
90. A830522
91. Dexamethasone 21-phosphate Disodium Salt, >=98%
92. Dexamethasone Sodium Phosphate [green Book]
93. Dexamethasone Sodium Phosphate [orange Book]
94. Dexamethasone Sodium Phosphate [usp Impurity]
95. Dexamethasoni Natrii Phosphas [who-ip Latin]
96. Dexamethasone 21-phosphate Disodium Salt [mi]
97. Dexamethasone Sodium Phosphate [usp Monograph]
98. Q27106391
99. Neodecadron Component Dexamethasone Sodium Phosphate
100. Dexamethasone Sodium Phosphate Component Of Neodecadron
101. Dexamethasone Sodium Phosphate, British Pharmacopoeia (bp) Reference Standard
102. Dexamethasone Sodium Phosphate, European Pharmacopoeia (ep) Reference Standard
103. Dexamethasone Sodium Phosphate, United States Pharmacopeia (usp) Reference Standard
104. 9-fluoro-11.beta.,17,21-trihydroxy-16.alpha.-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen Phosphate) Disodium Salt
105. Dexamethasone Sodium Phosphate For Peak Identification, European Pharmacopoeia (ep) Reference Standard
106. Dexamethasone Sodium Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material
107. Disodium [2-[(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoranyl-10,13,16-trimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] Phosphate
108. Disodium 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-21-yl Phosphate
109. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, Sodium Salt (1:2), (11beta,16alpha)-
Molecular Weight | 516.4 g/mol |
---|---|
Molecular Formula | C22H28FNa2O8P |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 3 |
Exact Mass | 516.13012157 g/mol |
Monoisotopic Mass | 516.13012157 g/mol |
Topological Polar Surface Area | 147 Ų |
Heavy Atom Count | 34 |
Formal Charge | 0 |
Complexity | 962 |
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 | 3 |
1 of 2 | |
---|---|
Drug Name | Dexamethasone sodium phosphate |
Drug Label | Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water.... |
Active Ingredient | Dexamethasone sodium phosphate |
Dosage Form | Injectable; Solution/drops |
Route | Ophthalmic, otic; Injection |
Strength | eq 10mg phosphate/ml; eq 0.1% phosphate; eq 4mg phosphate/ml |
Market Status | Prescription |
Company | Fresenius Kabi Usa; Hikma Maple; Bausch And Lomb; Alcon Pharms; Luitpold; Agila Speclts |
2 of 2 | |
---|---|
Drug Name | Dexamethasone sodium phosphate |
Drug Label | Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water.... |
Active Ingredient | Dexamethasone sodium phosphate |
Dosage Form | Injectable; Solution/drops |
Route | Ophthalmic, otic; Injection |
Strength | eq 10mg phosphate/ml; eq 0.1% phosphate; eq 4mg phosphate/ml |
Market Status | Prescription |
Company | Fresenius Kabi Usa; Hikma Maple; Bausch And Lomb; Alcon Pharms; Luitpold; Agila Speclts |
Glucocorticoids
A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-04
Pay. Date : 2022-02-28
DMF Number : 6525
Submission : 1986-08-11
Status : Active
Type : II
Certificate Number : R1-CEP 1998-154 - Rev 06
Issue Date : 2021-07-07
Type : Chemical
Substance Number : 549
Status : Valid
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
Human Pharmalabs manufacturer of high quality corticosteroid APIs with a state of the art facility in Kalol Gandhinagar.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-28
Pay. Date : 2013-01-16
DMF Number : 3963
Submission : 1980-10-10
Status : Active
Type : II
Certificate Number : R2-CEP 1992-014 - Rev 07
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 549
Status : Valid
Registration Number : 222MF10092
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2010-03-17
Latest Date of Registration :
NDC Package Code : 82298-113
Start Marketing Date : 2011-02-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : BASH HEALTH KOREA CORP.
Registration Date : 2023-01-06
Registration Number : 20230106-209-J-1432
Manufacturer Name : EUROAPI France
Manufacturer Address : 4 La Paterie, 63480 VERTOLAYE, France
Available Reg Filing : ASMF |
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-04
Pay. Date : 2022-02-28
DMF Number : 6525
Submission : 1986-08-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-28
Pay. Date : 2013-01-16
DMF Number : 3963
Submission : 1980-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3684
Submission : 1980-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2378
Submission : 1974-12-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4497
Submission : 1982-03-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3841
Submission : 1980-05-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 582
Submission : 1963-06-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5971
Submission : 1985-08-07
Status : Inactive
Type : II
Dexamethasone Sodium Phosphate
Certificate Number : R1-CEP 1998-154 - Rev 06
Status : Valid
Issue Date : 2021-07-07
Type : Chemical
Substance Number : 549
Dexamethasone Sodium Phosphate
Certificate Number : R2-CEP 1992-014 - Rev 07
Status : Valid
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 549
Dexamethasone Sodium Phosphate
Certificate Number : R1-CEP 2008-026 - Rev 01
Status : Valid
Issue Date : 2021-08-24
Type : Chemical
Substance Number : 549
Dexamethasone Sodium Phosphate
Certificate Number : CEP 2024-065 - Rev 00
Status : Valid
Issue Date : 2025-01-03
Type : Chemical and TSE
Substance Number : 549
Dexamethasone Sodium Phosphate
Certificate Number : R1-CEP 2006-184 - Rev 00
Status : Valid
Issue Date : 2013-10-03
Type : Chemical
Substance Number : 549
Dexamethasone Sodium Phosphate
Certificate Number : R1-CEP 2013-142 - Rev 00
Status : Valid
Issue Date : 2020-05-15
Type : Chemical
Substance Number : 549
Dexamethasone Sodium Phosphate
Certificate Number : CEP 2023-042 - Rev 00
Status : Valid
Issue Date : 2025-04-08
Type : Chemical
Substance Number : 549
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
The proceeds from placement will be used to fund the clinical development of late-stage Erydex (dexamethasone sodium phosphate), which is being evaluated for the treatment of Ataxia Telangiectasia.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Brand Name: Erydex
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Nantahala Capital
Deal Size: $21.9 million Upfront Cash: $10.4 million
Deal Type: Private Placement June 12, 2025
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Nantahala Capital
Deal Size : $21.9 million
Deal Type : Private Placement
Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities
Details : The proceeds from placement will be used to fund the clinical development of late-stage Erydex (dexamethasone sodium phosphate), which is being evaluated for the treatment of Ataxia Telangiectasia.
Product Name : Erydex
Product Type : Steroid
Upfront Cash : $10.4 million
June 12, 2025
Details:
The Company intends to use the net proceeds for the clinical advancement of SP-102 (dexamethasone sodium phosphate), which is being evaluated for treating Lumbosacral Radicular Pain (Sciatica).
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Brand Name: SP-102
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Undisclosed
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 13, 2024
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $17.0 million
Deal Type : Public Offering
Scilex Holding Company Announces Closing of $17 Million Registered Direct Offering
Details : The Company intends to use the net proceeds for the clinical advancement of SP-102 (dexamethasone sodium phosphate), which is being evaluated for treating Lumbosacral Radicular Pain (Sciatica).
Product Name : SP-102
Product Type : Steroid
Upfront Cash : Undisclosed
December 13, 2024
Details:
The Company intends to use the net proceeds for the clinical advancement of SP-102 (dexamethasone sodium phosphate), which is being evaluated for treating Lumbosacral Radicular Pain (Sciatica).
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Brand Name: SP-102
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Undisclosed
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 12, 2024
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $17.0 million
Deal Type : Public Offering
Scilex Holding Company Announces $17 Million Registered Direct Offering
Details : The Company intends to use the net proceeds for the clinical advancement of SP-102 (dexamethasone sodium phosphate), which is being evaluated for treating Lumbosacral Radicular Pain (Sciatica).
Product Name : SP-102
Product Type : Steroid
Upfront Cash : Undisclosed
December 12, 2024
Details:
EryDex (dexamethasone sodium phosphate) is a glucocorticoid receptor agonist, which is being evaluated in the late-stage clinical trial studies for the treatment of Ataxia-Telangiectasia.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Brand Name: EryDex
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 25, 2024
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Quince Announces First Patient Dosed in Phase 3 Trial of EryDex for Ataxia-Telangiectasia
Details : EryDex (dexamethasone sodium phosphate) is a glucocorticoid receptor agonist, which is being evaluated in the late-stage clinical trial studies for the treatment of Ataxia-Telangiectasia.
Product Name : EryDex
Product Type : Steroid
Upfront Cash : Inapplicable
June 25, 2024
Details:
Semnur’s lead program, Semdexa (dexamethasone sodium phosphate), is the first non-opioid novel injectable corticosteroid gel formulation for moderate to severe chronic radicular sciatica.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Neurology Brand Name: Semdexa
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Denali Capital Acquisition Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger March 09, 2024
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Denali Capital Acquisition Corp
Deal Size : Undisclosed
Deal Type : Merger
Semnur to go Public via SPAC Merger with Denali Capital in $2.5 bln Deal
Details : Semnur’s lead program, Semdexa (dexamethasone sodium phosphate), is the first non-opioid novel injectable corticosteroid gel formulation for moderate to severe chronic radicular sciatica.
Product Name : Semdexa
Product Type : Steroid
Upfront Cash : Undisclosed
March 09, 2024
Details:
EryDex (dexamethasone sodium phosphate), utilizing company's AIDE technology, is in Phase 3 for treating Ataxia-Telangiectasia, a rare pediatric condition.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Brand Name: EryDex
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 06, 2024
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Quince Therapeutics Receives U.S. FDA Fast Track Designation for EryDex System
Details : EryDex (dexamethasone sodium phosphate), utilizing company's AIDE technology, is in Phase 3 for treating Ataxia-Telangiectasia, a rare pediatric condition.
Product Name : EryDex
Product Type : Steroid
Upfront Cash : Inapplicable
March 06, 2024
Details:
Through the acquisition, Quince gains right for EryDel's Phase 3 lead asset, EryDex (dexamethasone sodium phosphate), targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Brand Name: EryDex
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Quince Therapeutics
Deal Size: $485.0 million Upfront Cash: $485.0 million
Deal Type: Acquisition October 23, 2023
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Quince Therapeutics
Deal Size : $485.0 million
Deal Type : Acquisition
Quince Therapeutics Completes Acquisition of EryDel S.p.A.
Details : Through the acquisition, Quince gains right for EryDel's Phase 3 lead asset, EryDex (dexamethasone sodium phosphate), targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.
Product Name : EryDex
Product Type : Steroid
Upfront Cash : $485.0 million
October 23, 2023
Details:
EryDex (dexamethasone sodium phosphate) utilizes a unique drug/device combination that enables a fully automated process at the point of patient care for the autologous intracellular drug encapsulation for the Treatment of Ataxia-Telangiectasia.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Brand Name: EryDex
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 28, 2023
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Partial Clinical Hold Lifted on IND for EryDel’s Lead Phase 3 Asset EryDex for the Trea...
Details : EryDex (dexamethasone sodium phosphate) utilizes a unique drug/device combination that enables a fully automated process at the point of patient care for the autologous intracellular drug encapsulation for the Treatment of Ataxia-Telangiectasia.
Product Name : EryDex
Product Type : Steroid
Upfront Cash : Inapplicable
September 28, 2023
Details:
Through the acquisition, Quince gains right for EryDel's Phase 3 lead asset, EryDex (dexamethasone sodium phosphate), targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Genetic Disease Brand Name: EryDex
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Quince Therapeutics
Deal Size: $485.0 million Upfront Cash: $485.0 million
Deal Type: Acquisition July 24, 2023
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Quince Therapeutics
Deal Size : $485.0 million
Deal Type : Acquisition
Details : Through the acquisition, Quince gains right for EryDel's Phase 3 lead asset, EryDex (dexamethasone sodium phosphate), targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.
Product Name : EryDex
Product Type : Steroid
Upfront Cash : $485.0 million
July 24, 2023
Details:
SP-102 (semdexatm) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment for Lumbosacral Radicular Pain (Sciatica) in the trial is projected to occur in 2025.
Lead Product(s): Dexamethasone Sodium Phosphate
Therapeutic Area: Musculoskeletal Brand Name: Semdexa
Study Phase: Phase IIIProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 11, 2023
Lead Product(s) : Dexamethasone Sodium Phosphate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SP-102 (semdexatm) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment for Lumbosacral Radicular Pain (Sciatica) in the trial is projected to occur in 2025.
Product Name : Semdexa
Product Type : Steroid
Upfront Cash : Inapplicable
February 11, 2023
Regulatory Info : DISCN
Registration Country : USA
DEXAMETHASONE SODIUM PHOSPHATE
Brand Name : HEXADROL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 14694
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
DEXAMETHASONE SODIUM PHOSPHATE
Brand Name : HEXADROL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 14694
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
DEXAMETHASONE SODIUM PHOSPHATE
Brand Name : HEXADROL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 20MG PHOSPHATE/ML
Packaging :
Approval Date : 1982-01-01
Application Number : 14694
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Originator
Registration Country : South Africa
Dexamethasone sodium phosphate
Brand Name : Voxidex
Dosage Form : EED
Dosage Strength : 1mg/ml
Packaging : 1X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
DEXAMETHASONE SODIUM PHOSPHATE
Brand Name : DEXAMETHASONE SODIUM PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG PHOSPHATE/ML
Packaging :
Approval Date : 1986-04-09
Application Number : 89169
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXAMETHASONE SODIUM PHOSPHATE
Brand Name : DEXAMETHASONE SODIUM PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG PHOSPHATE/ML
Packaging :
Approval Date : 2015-12-01
Application Number : 206781
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Dexamethasone Sodium Phosphate
Brand Name :
Dosage Form : Injection
Dosage Strength : 4MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Italy
Dexamethasone Sodium Phosphate
Brand Name : DECADRON
Dosage Form : Injection
Dosage Strength : 4MG/ML
Packaging : 3 ampoules, 6 ampoules
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : RX
Registration Country : USA
DEXAMETHASONE SODIUM PHOSPHATE
Brand Name : DEXAMETHASONE SODIUM PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10MG PHOSPHATE/ML
Packaging :
Approval Date : 2019-05-10
Application Number : 211036
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Cortiarscolloid
Dosage Form :
Dosage Strength : Concentrated 10 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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Dosage Form : Tablet
Grade : Oral, Topical
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Emulsifying Agents
Pharmacopoeia Ref : USP-NF, EP, JP
Technical Specs : Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solubilizer
Ingredient(s) : Polysorbate 80
Dosage Form : Emulsion
Grade : Topical
Application : Rheology Modifiers
Excipient Details : Thickener, Emulsifier, Stabilizer, Texturizing agent, pH Independent & Non Thixotropic polymer for Topical Range (Skin,Vaginal & Anal mucosa)
Pharmacopoeia Ref : In house having US DMF Type IV...
Technical Specs : Ready to use liquid polymer for topical applications (Gel / Cream / Lotion/ Foam based formulation, ...
Ingredient(s) : Hydroxyethyl Acrylate
Dosage Form : Capsule
Grade : Oral
Application : Solubilizers
Excipient Details : Polysorbate 80 in dry powder form, a solubilizing agent acts as a surfactant and increases the solubility of various oral dosage forms.
Pharmacopoeia Ref : USP-NF, EP, JP & having US DMF
Technical Specs : Solubilizer in powder form, used in directly compressible dosage forms, Wet granulation, added durin...
Ingredient(s) : Magnesium aluminium silicate Excipient
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PharmaCompass offers a list of Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate manufacturer or Dexamethasone Sodium Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexamethasone Sodium Phosphate manufacturer or Dexamethasone Sodium Phosphate supplier.
PharmaCompass also assists you with knowing the Dexamethasone Sodium Phosphate API Price utilized in the formulation of products. Dexamethasone Sodium Phosphate API Price is not always fixed or binding as the Dexamethasone Sodium Phosphate Price is obtained through a variety of data sources. The Dexamethasone Sodium Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dexagel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexagel, including repackagers and relabelers. The FDA regulates Dexagel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexagel 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 Dexagel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexagel supplier is an individual or a company that provides Dexagel active pharmaceutical ingredient (API) or Dexagel finished formulations upon request. The Dexagel suppliers may include Dexagel API manufacturers, exporters, distributors and traders.
click here to find a list of Dexagel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexagel DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexagel active pharmaceutical ingredient (API) in detail. Different forms of Dexagel DMFs exist exist since differing nations have different regulations, such as Dexagel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexagel DMF submitted to regulatory agencies in the US is known as a USDMF. Dexagel USDMF includes data on Dexagel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexagel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexagel 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 Dexagel Drug Master File in Japan (Dexagel JDMF) empowers Dexagel 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 Dexagel JDMF during the approval evaluation for pharmaceutical products. At the time of Dexagel 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 Dexagel 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 Dexagel Drug Master File in Korea (Dexagel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexagel. The MFDS reviews the Dexagel KDMF as part of the drug registration process and uses the information provided in the Dexagel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexagel 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 Dexagel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dexagel suppliers with KDMF on PharmaCompass.
A Dexagel CEP of the European Pharmacopoeia monograph is often referred to as a Dexagel Certificate of Suitability (COS). The purpose of a Dexagel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dexagel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dexagel to their clients by showing that a Dexagel CEP has been issued for it. The manufacturer submits a Dexagel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dexagel CEP holder for the record. Additionally, the data presented in the Dexagel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dexagel DMF.
A Dexagel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dexagel 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 Dexagel suppliers with CEP (COS) on PharmaCompass.
A Dexagel written confirmation (Dexagel WC) is an official document issued by a regulatory agency to a Dexagel manufacturer, verifying that the manufacturing facility of a Dexagel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexagel APIs or Dexagel finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexagel WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexagel 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 Dexagel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexagel 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 Dexagel 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 Dexagel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexagel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexagel suppliers with NDC on PharmaCompass.
Dexagel 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 Dexagel 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 Dexagel GMP manufacturer or Dexagel GMP API supplier for your needs.
A Dexagel CoA (Certificate of Analysis) is a formal document that attests to Dexagel's compliance with Dexagel specifications and serves as a tool for batch-level quality control.
Dexagel CoA mostly includes findings from lab analyses of a specific batch. For each Dexagel 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.
Dexagel may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexagel EP), Dexagel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexagel USP).