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Divalproex Sodium

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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ACTIVE PHARMA INGREDIENTS

67 API Suppliers, 36 USDMF, 10 CEP/COS, 3 JDMF, 7 EU WC, 9 KDMF, 15 NDC API, 34 Listed Suppliers, $ API Reference Price

67 API Suppliers
36 USDMF
10 CEP/COS
3 JDMF
7 EU WC
9 KDMF
15 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

264 FDF Dossiers, 109 FDA Orange Book, 57 Europe, 17 Canada, 30 Australia, 17 South Africa, 34 Listed Dossiers

264 FDF Dossiers
109 FDA Orange Book
57 Europe
17 Canada
30 Australia
17 South Africa
34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID, TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID, TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID, TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

drugProductComposition
CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID
TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID
TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID
CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID
TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID
TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

RELATED EXCIPIENT COMPANIES

3 Evonik, 3 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 14 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 38 BASF, 2 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 16 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 34 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 27 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus

relatedExcipients
3 Evonik
3 Rochem International Inc
19 SPI Pharma
2 Seqens
14 DKSH
2 Jai Radhe Sales
1 Pharm-RX Chemical
8 Faran Shimi Pharmaceutical
11 Boai NKY Pharmaceuticals Ltd
13 Gangwal Healthcare
9 Nanjing Well Pharmaceutical
2 Pfanstiehl
4 ACG Worldwide
8 Actylis
1 Aeon Procare
3 Alcedo Pharmachem
11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
38 BASF
2 Clariant
18 Corel Pharma Chem
6 DFE Pharma
3 Doshion Polyscience
2 Finar
13 Gangwal Chemicals
1 Huzhou Sunflower Pharmaceutical
16 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
34 Kerry
4 Kima Chemical
6 Lonza Capsugel
18 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
5 Novo Excipients
4 Pharmatrans-Sanaq
8 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
27 Roquette
14 Seppic
8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
3 The Dow Chemical Company
3 Ulanqab Kema New Material
3 Valens Pharmachem
4 Vasa Pharmachem
2 Vertellus

EXCIPIENTS BY APPLICATIONS

110 Fillers, Diluents & Binders, 84 Coating Systems & Additives, 53 Direct Compression, 51 Controlled & Modified Release, 44 Disintegrants & Superdisintegrants, 42 Thickeners and Stabilizers, 40 Solubilizers, 35 Granulation, 33 Taste Masking, 28 Film Formers & Plasticizers, 26 Topical, 23 Parenteral, 23 Lubricants & Glidants, 21 Co-Processed Excipients, 18 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 10 API Stability Enhancers, 10 Rheology Modifiers, 9 Empty Capsules, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 60 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
60 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 91 Finished Drug Prices, 5 Annual Reports

globalSalesInformation
6 US Medicaid Prescriptions
91 Finished Drug Prices
5 Annual Reports

MARKET PLACE

25 APIs, 16 FDF Dossiers

marketPlace
25 APIs
16 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM , 3 USP , 4 Others

otherSolutions
2 EDQM
3 USP
4 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 36

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

264

FDF Dossiers

109

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

197,451,958

Annual Reports (USD Million)

1,934

Finished Drug Prices

386 RELATED EXCIPIENT COMPANIES

686EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 76584-70-8, Valproate semisodium, Epival, Depakote, Sodium divalproate, Semisodium valproate

Molecular Formula

C₁₆H₃₁NaO₄

Molecular Weight

310.40 g/mol

InChI Key

MSRILKIQRXUYCT-UHFFFAOYSA-M

A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.

1 2D Structure

Divalproex Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;2-propylpentanoate;2-propylpentanoic acid

2.1.2 InChI

InChI=1S/2C8H16O2.Na/c2*1-3-5-7(6-4-2)8(9)10;/h2*7H,3-6H2,1-2H3,(H,9,10);/q;;+1/p-1

2.1.3 InChI Key

MSRILKIQRXUYCT-UHFFFAOYSA-M

2.1.4 Canonical SMILES

CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]

2.2 Synonyms

2.2.1 MeSH Synonyms

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. Ergenyl

11. Magnesium Valproate

12. Propylisopropylacetic Acid

13. Semisodium Valproate

14. Sodium Valproate

15. Valproate

16. Valproate Calcium

17. Valproate Sodium

18. Valproic Acid

19. Valproic Acid, Sodium Salt (2:1)

20. Vupral

2.2.2 Depositor-Supplied Synonyms

1. 76584-70-8

2. Valproate Semisodium

3. Epival

4. Depakote

5. Sodium Divalproate

6. Semisodium Valproate

7. Sprinkle

8. Abbott 50711

9. Divalproex

10. Valdisoval

11. Valproato Semisodico

12. Delepsine

13. Valcote

14. Valparin

15. Epilex

16. Valproate Semisodique

17. Sodium Hydrogen Divalproate

18. Valproatum Seminatricum

19. Sodium Hydrogen Bis(2-propylpentanoate)

20. Pentanoic Acid, 2-propyl-, Sodium Salt (2:1)

21. Abbott-50711

22. Sodium Hydrogen Bis(2-propylvalerate)

23. Divalproex Sodium [usan:usp]

24. Divalproex (sodium)

25. Sodium;2-propylpentanoate;2-propylpentanoic Acid

26. Valproate Semisodium (inn)

27. Depakote Er

28. Chebi:4667

29. Divalproate

30. Valproic Acid (semisodium Salt)

31. Depakote Cp

32. Valproate Semisodium [inn]

33. Valproate Semisodique [french]

34. Valproato Semisodico [spanish]

35. Valproatum Seminatricum [latin]

36. Valproic Acid Semisodium Salt

37. Depakote (tn)

38. Natrium Hydrogen Bis(2-propylvalerat)

39. Valproic Acid Semisodium Salt (2:1)

40. 644vl95ao6

41. Valproic Acid Sodium Salt (2:1)

42. Divalproex Sodium (usp)

43. Unii-644vl95ao6

44. Sodium Divalproex

45. Sodium Hydrogen Bis(2-propylvalerate), Oligomer

46. Sodium; 2-propylpentanoate; 2-propylpentanoic Acid

47. Schembl40996

48. Chembl2105613

49. Sodium;hydron;2-propylpentanoate

50. Dtxsid70227388

51. Hms3651c17

52. Hms3884o06

53. Bcp12800

54. S1703

55. Sodiumhydrogenbis(2-propylpentanoate)

56. Akos015895200

57. Ccg-267581

58. As-17254

59. Db-056089

60. Ft-0625375

61. Sw219169-1

62. C76453

63. D00304

64. Ab01568255_01

65. A838751

66. Sodium 2-propylpentanoate--2-propylpentanoic Acid (1:1)

2.3 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₃₁NaO₄
Molecular Weight	310.40 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	10
Exact Mass	310.21200375 g/mol
Monoisotopic Mass	310.21200375 g/mol
Topological Polar Surface Area	77.4 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	192
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	3

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Depakote
Drug Label	Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d...
Active Ingredient	Divalproex sodium
Dosage Form	Capsule, delayed rel pellets; Tablet, delayed release
Route	Oral
Strength	eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market Status	Prescription
Company	Abbvie

2 of 6
Drug Name	Depakote er
Drug Label	Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d...
Active Ingredient	Divalproex sodium
Dosage Form	Tablet, extended release
Route	oral; Oral
Strength	250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg
Market Status	Prescription
Company	Abbott; Abbvie

3 of 6
Drug Name	Divalproex sodium
Drug Label	Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:Di...
Active Ingredient	Divalproex sodium
Dosage Form	Tablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release
Route	Oral
Strength	eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market Status	Prescription
Company	Anchen Pharms; Wockhardt; Upsher Smith; Nu Pharm; Actavis Labs Fl; Teva; Vintage; Aurobindo Pharma; Sun Pharm Inds; Reddys; Lupin; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare; Mylan; Unichem Labs; Impax Labs

4 of 6
Drug Name	Depakote
Drug Label	Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d...
Active Ingredient	Divalproex sodium
Dosage Form	Capsule, delayed rel pellets; Tablet, delayed release
Route	Oral
Strength	eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market Status	Prescription
Company	Abbvie

5 of 6
Drug Name	Depakote er
Drug Label	Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d...
Active Ingredient	Divalproex sodium
Dosage Form	Tablet, extended release
Route	oral; Oral
Strength	250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg
Market Status	Prescription
Company	Abbott; Abbvie

6 of 6
Drug Name	Divalproex sodium
Drug Label	Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:Di...
Active Ingredient	Divalproex sodium
Dosage Form	Tablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release
Route	Oral
Strength	eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market Status	Prescription
Company	Anchen Pharms; Wockhardt; Upsher Smith; Nu Pharm; Actavis Labs Fl; Teva; Vintage; Aurobindo Pharma; Sun Pharm Inds; Reddys; Lupin; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare; Mylan; Unichem Labs; Impax Labs

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Decreased Central Nervous System Disorganized Electrical Activity [PE]; Mood Stabilizer [EPC]; Anti-epileptic Agent [EPC]

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KDMF

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - CAPSULE;ORAL - 250MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18081

DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Reg...DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18082

DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 12...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID

USFDA APPLICATION NUMBER - 18723

DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 25...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID

USFDA APPLICATION NUMBER - 18723

DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID

USFDA APPLICATION NUMBER - 18723

DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID

USFDA APPLICATION NUMBER - 19680

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID

USFDA APPLICATION NUMBER - 21168

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

USFDA APPLICATION NUMBER - 21168

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ACTIVE PHARMA INGREDIENTS

67 API Suppliers

36 USDMF

10 CEP/COS

3 JDMF

7 EU WC

9 KDMF

15 NDC API

34 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

264 FDF Dossiers

109 FDA Orange Book

57 Europe

17 Canada

30 Australia

17 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID

TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID

TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID

TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID

TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

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CAPSULE;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SYRUP;ORAL - 250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons