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1. 2 Propylpentanoic Acid
2. 2-propylpentanoic Acid
3. Calcium Valproate
4. Convulsofin
5. Depakene
6. Depakine
7. Depakote
8. Dipropyl Acetate
9. Divalproex
10. Divalproex Sodium
11. Ergenyl
12. Magnesium Valproate
13. Propylisopropylacetic Acid
14. Semisodium Valproate
15. Valproate
16. Valproate Calcium
17. Valproate Sodium
18. Valproic Acid
19. Valproic Acid, Sodium Salt (2:1)
20. Vupral
1. Sodium 2-propylpentanoate
2. 1069-66-5
3. Valproate Sodium
4. Valproic Acid Sodium Salt
5. Valproic Acid Sodium
6. Depacon
7. Sodium 2-propylvalerate
8. Epilim
9. Valproic Acid, Sodium Salt
10. Pentanoic Acid, 2-propyl-, Sodium Salt
11. 2-propylvaleric Acid Sodium Salt
12. Valerin
13. 2-propylpentanoic Acid Sodium Salt
14. Valproic Acid Sodium Salt (1:1)
15. Valproic Acid (sodium Salt)
16. Selenica
17. Abbott 44090
18. Valproate Sodium [usan]
19. Valproate
20. Valproic Acid, Sodium
21. Valproic Acid Sodium Salt (sodium Valproate)
22. Sodium;2-propylpentanoate
23. Mfcd00078604
24. 5vom6gyj0d
25. Abbott-44090
26. Chebi:9925
27. Eurekene
28. Labazene
29. Orfiril
30. Kw-6066n
31. Nsc-732626
32. Nsc-757376
33. Depakene (tn)
34. Natrium Valproat
35. Valproate Sodium (usan)
36. A-44090
37. Dipropylacetate Sodium
38. Sodium Dipropylacetate
39. Sodium Bispropylacetate
40. Chembl433
41. Valproinsaeure, Natrium
42. Sodium N-dipropylacetate
43. 2-propylpentanoic Acid Sodium
44. Smr000875243
45. Sodium 2-n-propyl-pentanoate
46. Kw 6066n
47. Einecs 213-961-8
48. Unii-5vom6gyj0d
49. Valeric Acid, 2-propyl-, Sodium Salt
50. Natrii Valproas
51. Valproate Sodium [usan:usp]
52. Valproicacidsodium
53. Selenica (tn)
54. Valproic Acid (sodium)
55. Lopac-p-4543
56. Sodium Valproate (jp17)
57. Dsstox_cid_17072
58. Dsstox_rid_79301
59. Dsstox_gsid_37072
60. Schembl35027
61. Mls001332431
62. Mls001332432
63. Mls002153189
64. Spectrum1500606
65. Sodium Valproate [jan]
66. Dtxsid5037072
67. Valproate Sodium [vandf]
68. Hms500n15
69. Valproic Acid Sodium Salt, 98%
70. Sodium Valproate [mart.]
71. Sodium Valproate [who-ip]
72. Valproate Sodium [who-dd]
73. Hms1921i21
74. Hms2092c12
75. Hms2230e16
76. Hms3262b20
77. Hms3369l11
78. Hms3648a12
79. Hms3654i14
80. Hms3872g13
81. Hms3884e05
82. Bcp02888
83. Tox21_302623
84. Tox21_500889
85. Ccg-40071
86. Hy-10585a
87. S1168
88. 2-propyl-pentanoic Acid, Sodium Salt
89. Akos005066057
90. Valproate Sodium [orange Book]
91. Ac-8391
92. Ccg-208088
93. Ccg-266330
94. Cs-1764
95. Lp00889
96. Natrii Valproas [who-ip Latin]
97. Nsc 732626
98. Nsc 757376
99. Sodium Valproate [ep Monograph]
100. Valproate Sodium [usp Impurity]
101. Ncgc00016192-01
102. Ncgc00016192-02
103. Ncgc00016192-03
104. Ncgc00016192-04
105. Ncgc00094208-01
106. Ncgc00094208-02
107. Ncgc00094208-03
108. Ncgc00167849-01
109. Ncgc00256651-01
110. Ncgc00261574-01
111. As-13150
112. Sy058189
113. 2-propylpentanoic Acid Sodium Salt (1:1)
114. Bcp0726000316
115. Cas-1069-66-5
116. Db-059527
117. Sodium 2-propylpentanoate [who-ip]
118. Eu-0100889
119. Ft-0633278
120. S0894
121. Sw219169-2
122. D00710
123. H11308
124. P 4543
125. Valproic Acid Sodium Salt (1:1) [mi]
126. Pentanoic Acid, 2-propyl-, Sodium Salt (1:1)
127. Valproic Acid, Sodium Salt - Cas 1069-66-5
128. Q-201918
129. Q4347890
130. Sodium Valproate, British Pharmacopoeia (bp) Reference Standard
131. Sodium Valproate, European Pharmacopoeia (ep) Reference Standard
132. Sodium Valproate, 2-propylpentanoic Acid . Na, Sodium 2-propylpentanoate
Molecular Weight | 166.19 g/mol |
---|---|
Molecular Formula | C8H15NaO2 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 5 |
Exact Mass | 166.09697400 g/mol |
Monoisotopic Mass | 166.09697400 g/mol |
Topological Polar Surface Area | 40.1 Ų |
Heavy Atom Count | 11 |
Formal Charge | 0 |
Complexity | 98.3 |
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 | 2 |
1 of 4 | |
---|---|
Drug Name | Depacon |
PubMed Health | Valproate Sodium (Injection) |
Drug Classes | Anticonvulsant |
Drug Label | Depacon (valproate sodium) is the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, cry... |
Active Ingredient | Valproate sodium |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 100mg base/ml |
Market Status | Prescription |
Company | Abbvie |
2 of 4 | |
---|---|
Drug Name | Valproate sodium |
PubMed Health | Valproate Sodium (Injection) |
Drug Classes | Anticonvulsant |
Drug Label | Valproate sodium injection, USPis the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorles... |
Active Ingredient | Valproate sodium |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 100mg base/ml |
Market Status | Prescription |
Company | Bedford; Hikma Farmaceutica; Fresenius Kabi Usa |
3 of 4 | |
---|---|
Drug Name | Depacon |
PubMed Health | Valproate Sodium (Injection) |
Drug Classes | Anticonvulsant |
Drug Label | Depacon (valproate sodium) is the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, cry... |
Active Ingredient | Valproate sodium |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 100mg base/ml |
Market Status | Prescription |
Company | Abbvie |
4 of 4 | |
---|---|
Drug Name | Valproate sodium |
PubMed Health | Valproate Sodium (Injection) |
Drug Classes | Anticonvulsant |
Drug Label | Valproate sodium injection, USPis the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorles... |
Active Ingredient | Valproate sodium |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 100mg base/ml |
Market Status | Prescription |
Company | Bedford; Hikma Farmaceutica; Fresenius Kabi Usa |
Anticonvulsants
Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)
Antimanic Agents
Agents that are used to treat bipolar disorders or mania associated with other affective disorders. (See all compounds classified as Antimanic Agents.)
Enzyme Inhibitors
Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)
GABA Agents
Substances used for their pharmacological actions on GABAergic systems. GABAergic agents include agonists, antagonists, degradation or uptake inhibitors, depleters, precursors, and modulators of receptor function. (See all compounds classified as GABA Agents.)
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2022-01-10
Registration Number : 20210604-209-J-1010(1)
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Chem Pole 64, Avenue Du Lac, Mourenx, 64150, France
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : CEP 2004-198 - Rev 05
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 678
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-25
Pay. Date : 2019-09-18
DMF Number : 33350
Submission : 2019-09-24
Status : Active
Type : II
Certificate Number : R1-CEP 2004-302 - Rev 04
Issue Date : 2019-07-26
Type : Chemical
Substance Number : 678
Status : Valid
Registration Number : 229MF10059
Registrant's Address : No. 61, Ln. 309, Haihu N. Rd. , Luzhu Dist. , Taoyuan City 33856, Taiwan
Initial Date of Registration : 2017-03-03
Latest Date of Registration :
NDC Package Code : 68108-0233
Start Marketing Date : 2004-06-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-10-19
Registration Number : 20211019-209-J-1049
Manufacturer Name : SCI Pharmtech, Inc.
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist., Taoyuan City 33856, Taiwan
Available Reg Filing : CN |
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2021-06-04
Registration Number : 20210604-209-J-1010
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Chem Pole 64, Avenue Du Lac, Mourenx, 64150, France
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41502
Submission : 2025-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5159
Submission : 1983-12-05
Status : Inactive
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-25
Pay. Date : 2019-09-18
DMF Number : 33350
Submission : 2019-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5159
Submission : 1983-12-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41502
Submission : 2025-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11786
Submission : 1995-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-12
Pay. Date : 2014-09-25
DMF Number : 18007
Submission : 2005-01-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6015
Submission : 1985-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17225
Submission : 2004-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18016
Submission : 2005-01-19
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3329
Submission : 1978-07-13
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6519
Submission : 1986-08-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : CEP 2004-198 - Rev 05
Status : Valid
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 678
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Certificate Number : R1-CEP 2004-302 - Rev 04
Status : Valid
Issue Date : 2019-07-26
Type : Chemical
Substance Number : 678
Certificate Number : R1-CEP 2003-180 - Rev 03
Status : Valid
Issue Date : 2019-07-02
Type : Chemical
Substance Number : 678
Certificate Number : CEP 2020-373 - Rev 01
Status : Valid
Issue Date : 2025-03-17
Type : Chemical
Substance Number : 678
Certificate Number : CEP 2015-281 - Rev 01
Status : Valid
Issue Date : 2024-09-11
Type : Chemical
Substance Number : 678
Certificate Number : R1-CEP 1996-094 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2012-06-14
Type : Chemical
Substance Number : 678
Certificate Number : R1-CEP 2004-250 - Rev 01
Status : Valid
Issue Date : 2012-07-05
Type : Chemical
Substance Number : 678
Certificate Number : R1-CEP 1997-021 - Rev 03
Status : Valid
Issue Date : 2008-08-05
Type : Chemical
Substance Number : 678
Certificate Number : R1-CEP 2014-179 - Rev 01
Status : Valid
Issue Date : 2022-08-17
Type : Chemical
Substance Number : 678
Certificate Number : R1-CEP 2004-027 - Rev 04
Status : Valid
Issue Date : 2020-12-16
Type : Chemical
Substance Number : 678
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registration Number : 229MF10059
Registrant's Address : No. 61, Ln. 309, Haihu N. Rd. , Luzhu Dist. , Taoyuan City 33856, Taiwan
Initial Date of Registration : 2017-03-03
Latest Date of Registration : 2017-03-03
Registration Number : 305MF10098
Registrant's Address : GPD Admin Block, Plot No. 85-88, 105-109 & 112-116, SIPCOT Export Promotion Industria...
Initial Date of Registration : 2023-08-22
Latest Date of Registration : 2023-08-22
Japanese Pharmacopoeia Sodium Valproate (for manufacturing only)
Registration Number : 218MF10526
Registrant's Address : Snijderstraat 6,2222 BA, Katwijk, ZH The Netherlands
Initial Date of Registration : 2006-05-18
Latest Date of Registration : 2006-05-18
Registration Number : 304MF10081
Registrant's Address : Snijderstraat 6,2222 BA, Katwijk, ZH The Netherlands
Initial Date of Registration : 2022-05-25
Latest Date of Registration : 2022-05-25
Japanese Pharmacopoeia Sodium Valproate (for manufacturing only)
Registration Number : 228MF10202
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2016-10-31
Latest Date of Registration : 2016-10-31
Japanese Pharmacopoeia Sodium Valproate
Registration Number : 217MF10074
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2007-12-19
Date of Issue : 2020-05-05
Valid Till : 2022-11-21
Written Confirmation Number : WC-210
Address of the Firm : Plot No.109,110,115 &116, SIDCO Pharmaceutical Industrial Estate, Alathur-603 11...
Date of Issue : 2021-09-17
Valid Till : 2024-07-10
Written Confirmation Number : WC-0428
Address of the Firm : Plot No. 23 E, Survey No. 24P & 25P, AP SEZ Denotified Area, Lalamkoduru (V), Ra...
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm : Plot No. A-100, A-100/1, A-100/2 & D-1, M.I.D.C Ind. Area, Shendra, Aurangabad-4...
Date of Issue : 2022-09-30
Valid Till : 2025-10-09
Written Confirmation Number : WC-0243
Address of the Firm : Sathammai Village, Karunkuzhi Post, Madhuranthagam Taluk, Kancheepuram District,...
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159nA2
Address of the Firm : A-7/A-8, M.I.D.C Industrial Area, Ahmednagar-414111, Maharashtra, India
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2022-01-10
Registration Number : 20210604-209-J-1010(1)
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Chem Pole 64, Avenue Du Lac, Mourenx, 64150, France
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2021-06-04
Registration Number : 20210604-209-J-1010
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Chem Pole 64, Avenue Du Lac, Mourenx, 64150, France
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-10-19
Registration Number : 20211019-209-J-1049
Manufacturer Name : SCI Pharmtech, Inc.
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist., Taoyuan City 33856, Taiwan
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-08-31
Registration Number : 20210323-209-J-611(1)
Manufacturer Name : Katwijk Chemie BV
Manufacturer Address : Snijderstraat 6, Katwijk ZH, 2222BA, Netherlands
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-209-J-611
Manufacturer Name : Katwijk Chemie BV
Manufacturer Address : Snijderstraat 6, Katwijk ZH, 2222BA, Netherlands
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Details:
CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for pulmonary arterial hypertension.
Lead Product(s): Divalproex Sodium,Sodium Valproate
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: CS1
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 30, 2024
Lead Product(s) : Divalproex Sodium,Sodium Valproate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Cereno's HDAC Inhibitor Reduces Risks from PAH in Phase 2 Trial
Details : CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for pulmonary arterial hypertension.
Product Name : CS1
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 30, 2024
Details:
The Company plans to use proceeds to complete an international Phase 2 double-blind, randomized, placebo-controlled clinical trial of its investigational drug Valproic Acid (CT-010) for the treatment of uncontrolled seizures in patients with medically refractory epilepsy.
Lead Product(s): Sodium Valproate
Therapeutic Area: Neurology Brand Name: CT-010
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Lynx1 Capital Management
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing June 28, 2022
Lead Product(s) : Sodium Valproate
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Lynx1 Capital Management
Deal Size : $40.0 million
Deal Type : Series C Financing
Cerebral Therapeutics, Inc. Secures $40 Million Series C Financing
Details : The Company plans to use proceeds to complete an international Phase 2 double-blind, randomized, placebo-controlled clinical trial of its investigational drug Valproic Acid (CT-010) for the treatment of uncontrolled seizures in patients with medically re...
Product Name : CT-010
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
June 28, 2022
Details:
The Phase 2b, randomized, placebo-controlled, double-blind study is designed to expand on positive results of the ongoing Phase 1b/2a study assessing the safety and efficacy of intracerebroventricular administration of sodium valproate.
Lead Product(s): Sodium Valproate
Therapeutic Area: Neurology Brand Name: CT-010
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 17, 2020
Lead Product(s) : Sodium Valproate
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Phase 2b, randomized, placebo-controlled, double-blind study is designed to expand on positive results of the ongoing Phase 1b/2a study assessing the safety and efficacy of intracerebroventricular administration of sodium valproate.
Product Name : CT-010
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 17, 2020
Details:
The funding will help the company to initiate Phase 2b clinical trial for the treatment of medically refractory epilepsy in 2020.
Lead Product(s): Sodium Valproate
Therapeutic Area: Neurology Brand Name: CT-010
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: RA Capital Management
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing July 01, 2020
Lead Product(s) : Sodium Valproate
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : RA Capital Management
Deal Size : $35.0 million
Deal Type : Series B Financing
Cerebral Therapeutics Completes $35 Million Series B Financing
Details : The funding will help the company to initiate Phase 2b clinical trial for the treatment of medically refractory epilepsy in 2020.
Product Name : CT-010
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 01, 2020
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Ergenyl
Dosage Form : ENTEROTABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Ergenyl
Dosage Form : ENTEROTABLETT
Dosage Strength : 300 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Ergenyl
Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA
Dosage Strength : 400 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Depakin
Dosage Form : Valproic Acid (Sodium Salt) 20% 40Ml Oral Use
Dosage Strength : os soluz 40 ml 200 mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Depakin
Dosage Form : Valproic Acid (Sodium Salt) 500Mg 40 Combined Oral Use
Dosage Strength : 40 cpr gastrores 500 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : DEPAKIN
Dosage Form : Oral Solution
Dosage Strength : 200 mg/ml
Packaging : 40 ML 20% - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Acidum valproicum; sodium valproas
Brand Name : Depakine Chrono
Dosage Form : Film-Coated Tablets
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Acidum valproicum; sodium valproas
Brand Name : Valproate Chrono Sanofi
Dosage Form : Filmtabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
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Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Acidum valproicum; sodium valproas
Brand Name : Valproate Chrono Sanofi
Dosage Form : Filmtabl
Dosage Strength : 500mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Depakine
Dosage Form : Syrup
Dosage Strength : 300mg/5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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PharmaCompass offers a list of Sodium Valproate 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 Sodium Valproate manufacturer or Sodium Valproate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Valproate manufacturer or Sodium Valproate supplier.
PharmaCompass also assists you with knowing the Sodium Valproate API Price utilized in the formulation of products. Sodium Valproate API Price is not always fixed or binding as the Sodium Valproate Price is obtained through a variety of data sources. The Sodium Valproate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Valproate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valproate Sodium, including repackagers and relabelers. The FDA regulates Valproate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valproate Sodium 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 Valproate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valproate Sodium supplier is an individual or a company that provides Valproate Sodium active pharmaceutical ingredient (API) or Valproate Sodium finished formulations upon request. The Valproate Sodium suppliers may include Valproate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Valproate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valproate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Valproate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Valproate Sodium DMFs exist exist since differing nations have different regulations, such as Valproate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valproate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Valproate Sodium USDMF includes data on Valproate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valproate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valproate Sodium 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 Valproate Sodium Drug Master File in Japan (Valproate Sodium JDMF) empowers Valproate Sodium 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 Valproate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Valproate Sodium 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 Valproate Sodium 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 Valproate Sodium Drug Master File in Korea (Valproate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valproate Sodium. The MFDS reviews the Valproate Sodium KDMF as part of the drug registration process and uses the information provided in the Valproate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valproate Sodium 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 Valproate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valproate Sodium suppliers with KDMF on PharmaCompass.
A Valproate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Valproate Sodium Certificate of Suitability (COS). The purpose of a Valproate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valproate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valproate Sodium to their clients by showing that a Valproate Sodium CEP has been issued for it. The manufacturer submits a Valproate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valproate Sodium CEP holder for the record. Additionally, the data presented in the Valproate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valproate Sodium DMF.
A Valproate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valproate Sodium 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 Valproate Sodium suppliers with CEP (COS) on PharmaCompass.
A Valproate Sodium written confirmation (Valproate Sodium WC) is an official document issued by a regulatory agency to a Valproate Sodium manufacturer, verifying that the manufacturing facility of a Valproate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valproate Sodium APIs or Valproate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Valproate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Valproate Sodium 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 Valproate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valproate Sodium 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 Valproate Sodium 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 Valproate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valproate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valproate Sodium suppliers with NDC on PharmaCompass.
Valproate Sodium 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 Valproate Sodium 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 Valproate Sodium GMP manufacturer or Valproate Sodium GMP API supplier for your needs.
A Valproate Sodium CoA (Certificate of Analysis) is a formal document that attests to Valproate Sodium's compliance with Valproate Sodium specifications and serves as a tool for batch-level quality control.
Valproate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Valproate Sodium 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.
Valproate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Valproate Sodium EP), Valproate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valproate Sodium USP).