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1. 1 Phenyl 3 Methyl 5 Pyrazolone
2. 1-phenyl-3-methyl-5-pyrazolone
3. 3 Methyl 1 Phenyl 2 Pyrazolin 5 One
4. 3-methyl-1-phenyl-2-pyrazolin-5-one
5. Edarabone
6. Mci 186
7. Mci-186
8. Mci186
9. Norantipyrine
10. Norphenazone
11. Phenylmethylpyrazolone
12. Radicava
1. 89-25-8
2. 3-methyl-1-phenyl-2-pyrazolin-5-one
3. Radicut
4. Norphenazone
5. Mci-186
6. Developer Z
7. Methylphenylpyrazolone
8. Norantipyrine
9. C.i. Developer 1
10. Phenyl Methyl Pyrazolone
11. Phenylmethylpyrazolone
12. Radicava
13. 3-methyl-1-phenyl-1h-pyrazol-5(4h)-one
14. 5-methyl-2-phenyl-2,4-dihydro-3h-pyrazol-3-one
15. 1-phenyl-3-methyl-5-oxo-2-pyrazoline
16. 5-methyl-2-phenyl-4h-pyrazol-3-one
17. 1-phenyl-3-methylpyrazolone
18. 3h-pyrazol-3-one, 2,4-dihydro-5-methyl-2-phenyl-
19. 1-phenyl-3-methylpyrazolone-5
20. 3-methyl-1-phenylpyrazol-5-one
21. 3-methyl-1-phenyl-2-pyrazoline-5-one
22. Nci-c03952
23. 2-pyrazolin-5-one, 3-methyl-1-phenyl-
24. 5-pyrazolone, 3-methyl-1-phenyl-
25. 2,4-dihydro-5-methyl-2-phenyl-3h-pyrazol-3-one
26. Edaravone (mci-186)
27. 1-fenyl-3-methyl-2-pyrazolin-5-on
28. 3-methyl-1-phenyl-4,5-dihydro-1h-pyrazol-5-one
29. Chebi:31530
30. Nsc-2629
31. Nsc-26139
32. Antipyrine Related Compound A
33. Mls000069602
34. 3-methyl-1-phenyl-2-pyrazolin-5-one (mci-186)
35. Ci Developer 1
36. Ncgc00164015-01
37. Smr000059020
38. Dsstox_cid_1130
39. Dsstox_rid_75961
40. Dsstox_gsid_21130
41. Monopyrazolone
42. Wln: T5nmv Dhj Br& E1
43. Cas-89-25-8
44. Ccris 512
45. Radicut (tn)
46. Hsdb 4102
47. 3h-pyrazol-3-one,4-dihydro-5-methyl-2-phenyl-
48. Sr-01000000135
49. 1-fenyl-3-methyl-2-pyrazolin-5-on [czech]
50. Einecs 201-891-0
51. Mfcd00003138
52. Unii-s798v6yjrp
53. Brn 0609575
54. Ai3-03557
55. Mci186
56. (edaravone)
57. Radicava (tn)
58. (mci-186)
59. Cds1_000986
60. Spectrum_000267
61. Tocris-0786
62. Mci-186; Edaravone
63. Edaravone [usan:inn]
64. Maybridge1_005738
65. Opera_id_1057
66. Spectrum2_001574
67. Spectrum3_000971
68. Spectrum4_001091
69. Spectrum5_001217
70. M0687
71. Ec 201-891-0
72. Schembl4704
73. Bspbio_001235
74. Bspbio_002601
75. Kbiogr_000575
76. Kbiogr_001502
77. Kbioss_000575
78. Kbioss_000747
79. Ae-641/00371017
80. Mls001146878
81. Mls002415675
82. Mls006011753
83. Divk1c_001018
84. Divk1c_002026
85. Spectrum1503635
86. Spbio_001508
87. Chembl290916
88. Edaravone (usan/jp17/inn)
89. Dtxsid9021130
90. Bcbcmap01_000127
91. Gtpl11994
92. Hms503k17
93. Hms557m18
94. Kbio1_001018
95. Kbio2_000575
96. Kbio2_000747
97. Kbio2_003143
98. Kbio2_003315
99. Kbio2_005711
100. Kbio2_005883
101. Kbio3_001029
102. Kbio3_001030
103. Kbio3_001821
104. Nsc2629
105. Ninds_001018
106. Bcpp000246
107. Bio1_000438
108. Bio1_000927
109. Bio1_001416
110. Bio2_000448
111. Bio2_000928
112. Hms1362m17
113. Hms1792m17
114. Hms1990m17
115. Hms2234m19
116. Hms3266f04
117. Hms3403m17
118. Hms3411l05
119. Hms3654l15
120. Hms3675l05
121. Hms3884a11
122. Pharmakon1600-01503635
123. Act07289
124. Bcp26336
125. Hy-b0099
126. Nsc26139
127. Tox21_112077
128. Tox21_201747
129. Tox21_302819
130. Bdbm50200541
131. Ccg-39352
132. Nsc758622
133. S1326
134. Stk201315
135. Zinc18203737
136. 3-methyl-1-phenyl-2-pyrazolin-5one
137. Akos000313817
138. Tox21_112077_1
139. Ac-4745
140. Bcp9000635
141. Cs-1832
142. Db12243
143. Nsc-758622
144. Sb19128
145. Idi1_001018
146. Idi1_002203
147. 1-pehnyl-3-methyl-5-pyrazalone
148. Ncgc00018218-01
149. Ncgc00018218-02
150. Ncgc00018218-03
151. Ncgc00018218-04
152. Ncgc00018218-05
153. Ncgc00018218-06
154. Ncgc00018218-07
155. Ncgc00018218-08
156. Ncgc00018218-10
157. Ncgc00018218-17
158. Ncgc00022665-02
159. Ncgc00022665-04
160. Ncgc00022665-05
161. Ncgc00022665-06
162. Ncgc00256515-01
163. Ncgc00259296-01
164. Sbi-0051836.p002
165. Db-002517
166. Am20060748
167. Ft-0608243
168. Sw148216-2
169. 5-methyl-2-phenyl-2,4-dihydro-3-pyrazolone
170. 3-methyl-1-phenyl-2-pyrazoline-5-one, 99%
171. 4e-901
172. 5-methyl-2-phenyl-2,4-dihydro-pyrazol-3-one
173. D01552
174. D86209
175. 3-?methyl-?1-?phenyl-?2-?pyrazolin-?5-?one
176. Ab00375776_14
177. Ab00375776_15
178. 2 4-dihydro-5-methyl-2-phenyl-3h-pyrazol-3-one
179. 2,4-dihydro-2-phenyl-5-methyl-3h-pyrazol-3-one
180. A843105
181. Q335099
182. Q-200386
183. Sr-01000000135-2
184. Sr-01000000135-3
185. Sr-01000000135-5
186. 5-methyl-2-phenyl-2,4-dihydro-3h-pyrazol-3-one #
187. Brd-k35458079-001-04-2
188. Brd-k35458079-001-12-5
189. Brd-k35458079-001-23-2
190. Z50145861
191. F0391-0021
192. 3-methyl-1-phenyl-2-pyrazoline-5-one, Saj Special Grade
193. 3-methyl-1-phenyl-2-pyrazoline-5-one, Purum, >=98.0% (nt)
194. 5-methyl-2-phenyl-2,4-dihydro-3h-pyrazol-3-one (edaravone)
195. Phenazone Impurity A, European Pharmacopoeia (ep) Reference Standard
196. 5-methyl-2-phenyl-1,2-dihydropyrazol-3-one;3-methyl-1-phenyl-2-pyrazolin-5-one
197. Antipyrine Related Compound A, United States Pharmacopeia (usp) Reference Standard
Molecular Weight | 174.20 g/mol |
---|---|
Molecular Formula | C10H10N2O |
XLogP3 | 1.3 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 1 |
Exact Mass | 174.079312947 g/mol |
Monoisotopic Mass | 174.079312947 g/mol |
Topological Polar Surface Area | 32.7 Ų |
Heavy Atom Count | 13 |
Formal Charge | 0 |
Complexity | 241 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Indicated for improving neurological symptoms and damage from acute ischemic stroke and delaying disease progression of ALS.
FDA Label
Treatment of amyotrophic lateral sclerosis
Treatment of amyotrophic lateral sclerosis
Edaravone scavenges free hydroxyl radicals and peroxynitrite radicals which are highly associated with neuronal damage/death from many cerebral vascular disorders such as ischemic strokes and degenerative neurological disorders such as ALS. It exerts a neuroprotective and antioxidant effect and delays disease progression by limiting the extent of lipid peroxidation via free radical generation and cell membrane damage from oxidative stress. It reversed the reduction in regional blood flow and cerebral edema in a case of ischemic stroke.
Free Radical Scavengers
Substances that eliminate free radicals. Among other effects, they protect PANCREATIC ISLETS against damage by CYTOKINES and prevent myocardial and pulmonary REPERFUSION INJURY. (See all compounds classified as Free Radical Scavengers.)
Neuroprotective Agents
Drugs intended to prevent damage to the brain or spinal cord from ischemia, stroke, convulsions, or trauma. Some must be administered before the event, but others may be effective for some time after. They act by a variety of mechanisms, but often directly or indirectly minimize the damage produced by endogenous excitatory amino acids. (See all compounds classified as Neuroprotective Agents.)
N - Nervous system
N07 - Other nervous system drugs
N07X - Other nervous system drugs
N07XX - Other nervous system drugs
N07XX14 - Edaravone
Absorption
The peak plasma concentration of the parent drug is reached at the end of infusion, without accumulation of the drug with multiple dosing regimen. The mean Cmax value in healthy male adults is 888ng/mL for intravenous infusion. The values of AUC and Cmax are increased in a dose-proportional relationship. The oral bioavailability in mouse studies is 38% of the I.V. delivery.
Route of Elimination
About 0.7-0.9% of the dose is excreted as unchanged drug and 71.0-79.9% of the dose is excreted as metabolites (mostly as glucuronide conjugates) through mainly renal elimination.
Volume of Distribution
The mean Vd value following an intravenous infusion of a single 30mg dose is 18.5L/kg.
Clearance
The mean total plasma drug clearance following an intravenous infusion of a single 30mg dose is 0.1L/min.
Multiple renal and hepatic uridine diphosphate glucuronosyltransferase (UGT) isoforms catalyze glucuronidation reaction of edaravone to form glucuronide conjugates. Edaravone is also metabolized into sulfate conjugates via sulfotransferase activity, which is the main metabolite form predominantly found circulating in plasma. It is predicted that the sulfate conjugate is hydrolyzed back to edaravone, which is then converted to the glucuronide conjugate in the human kidney before excretion into the urine. These metabolites have no pharmacological activity.
The mean terminal elimination half-life of edaravone is 4.5 to 6 hours and the half-lives of its metabolites are 2 to 2.8 hours.
Nootropic and neuroprotective effects are mediated through inhibiting lipid peroxidation and scavenging free radicals. Edaravone acts to increase prostacyclin production, decrease lipoxygenase metabolism of arachidonic acid by trapping hydroxyl radicals, and inhibit alloxan-induced lipid peroxidation and quench active oxygen species. It targets various kinds of cells, including neurons, endothelial cells and myocardial cells. There is also evidence of reduction of neuronal nitric oxide synthase (nNOS) levels and potentiation of SOD1 levels after transient ischemia in rabbits thus preventing spinal cord injury.
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40910
Submission : 2025-02-26
Status : Active
Type : II
NDC Package Code : 64552-4098
Start Marketing Date : 2017-05-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-27
Pay. Date : 2024-01-22
DMF Number : 34751
Submission : 2020-06-16
Status : Active
Type : II
NDC Package Code : 73435-008
Start Marketing Date : 2020-12-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 34449
Submission : 2019-12-31
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-12-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 71796-017
Start Marketing Date : 2019-12-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-16
Pay. Date : 2020-10-23
DMF Number : 35204
Submission : 2020-09-29
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-2035
Start Marketing Date : 2020-09-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
NDC Package Code : 69037-0060
Start Marketing Date : 2017-05-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-24
Pay. Date : 2022-07-21
DMF Number : 34560
Submission : 2020-02-14
Status : Active
Type : II
Date of Issue : 2024-05-29
Valid Till : 2027-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
NDC Package Code : 72643-034
Start Marketing Date : 2023-05-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
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Details:
Sanbexin (a combination of edaravone and dexborneol) is a small molecule, sublingual tablet, which is being evaluated for the treatment of acute ischemic stroke.
Lead Product(s): Edaravone,Dexborneol
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Sanbexin
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2024
Lead Product(s) : Edaravone,Dexborneol
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Simcere’s Sanbexin® Approved in China for Acute Ischemic Stroke
Details : Sanbexin (a combination of edaravone and dexborneol) is a small molecule, sublingual tablet, which is being evaluated for the treatment of acute ischemic stroke.
Product Name : Sanbexin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 04, 2024
Details:
Radicava ORS (edaravone) is a free radical scavenger available in the form of oral suspension, which is approved by USFDA for the treatment of amyotrophic lateral sclerosis.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: Radicava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2024
Lead Product(s) : Edaravone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mitsubishi Tanabe Pharma America Receives Orphan Drug Exclusivity for RADICAVA ORS®
Details : Radicava ORS (edaravone) is a free radical scavenger available in the form of oral suspension, which is approved by USFDA for the treatment of amyotrophic lateral sclerosis.
Product Name : Radicava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 04, 2024
Details:
Sanbexin (a combination of edaravone and dexborneol) is a small molecule, sublingual tablet, which is being evaluated for the treatment of acute ischemic stroke.
Lead Product(s): Edaravone,Dexborneol
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Sanbexin
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2024
Lead Product(s) : Edaravone,Dexborneol
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sanbexin Sublingual Tablets Receive Breakthrough Therapy Designation from FDA
Details : Sanbexin (a combination of edaravone and dexborneol) is a small molecule, sublingual tablet, which is being evaluated for the treatment of acute ischemic stroke.
Product Name : Sanbexin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 09, 2024
Details:
Sanbexin (a combination of edaravone and dexborneol) is a small molecule, sublingual tablet, which is being evaluated for the treatment of acute ischemic stroke.
Lead Product(s): Edaravone,Dexborneol
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Sanbexin
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: NeuroDerm
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 20, 2024
Lead Product(s) : Edaravone,Dexborneol
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : NeuroDerm
Deal Size : Inapplicable
Deal Type : Inapplicable
Findings of a Phase III Clinical Study of Sanbexin® Sublingual Tablets Published in JAMA
Details : Sanbexin (a combination of edaravone and dexborneol) is a small molecule, sublingual tablet, which is being evaluated for the treatment of acute ischemic stroke.
Product Name : Sanbexin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 20, 2024
Details:
FAB122 (edaravone) is an investigational once daily, oral, small molecule drug candidate, which is currently being evaluated for the treatment of amyotrophic lateral sclerosis.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: FNP122
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 10, 2024
Ferrer Reports Top-Line Results from Phase III ADORE Study in ALS
Details : FAB122 (edaravone) is an investigational once daily, oral, small molecule drug candidate, which is currently being evaluated for the treatment of amyotrophic lateral sclerosis.
Product Name : FNP122
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 10, 2024
Details:
Under the licensing agreement, ST will be responsible for all marketing, regulatory and distribution activities of TW001, a unique oral formulation of edaravone which works by reducing the oxidative damage associated with neuron death in ALS, in Australia and New Zealand.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: TW001
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Specialised Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 28, 2023
Treeway Licensing Deal with Specialised Therapeutics
Details : Under the licensing agreement, ST will be responsible for all marketing, regulatory and distribution activities of TW001, a unique oral formulation of edaravone which works by reducing the oxidative damage associated with neuron death in ALS, in Australi...
Product Name : TW001
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 28, 2023
Details:
FAB122 (edaravone) is an investigational once daily, oral, small molecule drug candidate, which is currently being evaluated for the treatment of amyotrophic lateral sclerosis.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: FNP122
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 22, 2023
Ferrer Extends their Clinical Study in Amyotrophic Lateral Sclerosis (ALS)
Details : FAB122 (edaravone) is an investigational once daily, oral, small molecule drug candidate, which is currently being evaluated for the treatment of amyotrophic lateral sclerosis.
Product Name : FNP122
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 22, 2023
Details:
Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: Radicava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 23, 2023
Lead Product(s) : Edaravone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Product Name : Radicava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 23, 2023
Details:
Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: Radicava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2023
Lead Product(s) : Edaravone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Product Name : Radicava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 27, 2023
Details:
In clinical trials, the most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion, gait disturbance and headache. In an open-label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS (edaravone).
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: Radicava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 21, 2022
Lead Product(s) : Edaravone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mitsubishi Tanabe Pharma America Presents Data on RADICAVA ORS® (edaravone) at 2022 AANEM Annual ...
Details : In clinical trials, the most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion, gait disturbance and headache. In an open-label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS (edaravone).
Product Name : Radicava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 21, 2022
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PharmaCompass offers a list of Edaravone 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 Edaravone manufacturer or Edaravone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Edaravone manufacturer or Edaravone supplier.
PharmaCompass also assists you with knowing the Edaravone API Price utilized in the formulation of products. Edaravone API Price is not always fixed or binding as the Edaravone Price is obtained through a variety of data sources. The Edaravone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CAS-89-25-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-89-25-8, including repackagers and relabelers. The FDA regulates CAS-89-25-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-89-25-8 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A CAS-89-25-8 supplier is an individual or a company that provides CAS-89-25-8 active pharmaceutical ingredient (API) or CAS-89-25-8 finished formulations upon request. The CAS-89-25-8 suppliers may include CAS-89-25-8 API manufacturers, exporters, distributors and traders.
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A CAS-89-25-8 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-89-25-8 active pharmaceutical ingredient (API) in detail. Different forms of CAS-89-25-8 DMFs exist exist since differing nations have different regulations, such as CAS-89-25-8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-89-25-8 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-89-25-8 USDMF includes data on CAS-89-25-8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-89-25-8 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 CAS-89-25-8 Drug Master File in Japan (CAS-89-25-8 JDMF) empowers CAS-89-25-8 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 CAS-89-25-8 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-89-25-8 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A CAS-89-25-8 written confirmation (CAS-89-25-8 WC) is an official document issued by a regulatory agency to a CAS-89-25-8 manufacturer, verifying that the manufacturing facility of a CAS-89-25-8 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CAS-89-25-8 APIs or CAS-89-25-8 finished pharmaceutical products to another nation, regulatory agencies frequently require a CAS-89-25-8 WC (written confirmation) as part of the regulatory process.
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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 CAS-89-25-8 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CAS-89-25-8 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 CAS-89-25-8 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 CAS-89-25-8 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-89-25-8 NDC to their finished compounded human drug products, they may choose to do so.
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CAS-89-25-8 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 CAS-89-25-8 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 CAS-89-25-8 GMP manufacturer or CAS-89-25-8 GMP API supplier for your needs.
A CAS-89-25-8 CoA (Certificate of Analysis) is a formal document that attests to CAS-89-25-8's compliance with CAS-89-25-8 specifications and serves as a tool for batch-level quality control.
CAS-89-25-8 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-89-25-8 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.
CAS-89-25-8 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-89-25-8 EP), CAS-89-25-8 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-89-25-8 USP).