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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

Divalproex Sodium
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 Weight 310.40 g/mol
Molecular Formula C16H31NaO4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count10
Exact Mass310.21200375 g/mol
Monoisotopic Mass310.21200375 g/mol
Topological Polar Surface Area77.4 Ų
Heavy Atom Count21
Formal Charge0
Complexity192
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameDepakote
Drug LabelDivalproex 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 IngredientDivalproex sodium
Dosage FormCapsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAbbvie

2 of 6  
Drug NameDepakote er
Drug LabelDivalproex 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 IngredientDivalproex sodium
Dosage FormTablet, extended release
Routeoral; Oral
Strength250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg
Market StatusPrescription
CompanyAbbott; Abbvie

3 of 6  
Drug NameDivalproex sodium
Drug LabelDivalproex 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 IngredientDivalproex sodium
Dosage FormTablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAnchen 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 NameDepakote
Drug LabelDivalproex 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 IngredientDivalproex sodium
Dosage FormCapsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAbbvie

5 of 6  
Drug NameDepakote er
Drug LabelDivalproex 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 IngredientDivalproex sodium
Dosage FormTablet, extended release
Routeoral; Oral
Strength250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg
Market StatusPrescription
CompanyAbbott; Abbvie

6 of 6  
Drug NameDivalproex sodium
Drug LabelDivalproex 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 IngredientDivalproex sodium
Dosage FormTablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAnchen 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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RD LUZHU DIST., TAOYUAN CITY 33856 TAIWAN TW","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"VALPROIC ACID EP","address":"54-A, SIR MATHURADAS VASANJI ROAD","city":"MUMBAI, MAHARASHTRA","supplier":"SANOFI-AVENTIS SINGAPORE PTE LTD","supplierCountry":"FRANCE","foreign_port":"FOS SUR MER","customer":"SANOFI INDIA LIMITED","customerCountry":"INDIA","quantity":"1225.40","actualQuantity":"1225.4","unit":"KGS","unitRateFc":"18.9","totalValueFC":"25673.8","currency":"EURO","unitRateINR":"1760.5","date":"21-Oct-2024","totalValueINR":"2157283.62","totalValueInUsd":"25673.8","indian_port":"JNPT","hs_no":"29159099","bill_no":"6235984","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FOS SUR MER","supplierAddress":"38 BEACH ROAD # 18-11 SOUTH BEACH T OWER SINGAPORE 189767 SDNF Singapore","customerAddress":"54-A, SIR MATHURADAS VASANJI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"VALPROIC ACID EP","address":"54-A, SIR MATHURADAS VASANJI ROAD","city":"MUMBAI, MAHARASHTRA","supplier":"SANOFI-AVENTIS SINGAPORE PTE LTD","supplierCountry":"FRANCE","foreign_port":"FOS SUR MER","customer":"SANOFI INDIA LIMITED","customerCountry":"INDIA","quantity":"1225.60","actualQuantity":"1225.6","unit":"KGS","unitRateFc":"18.9","totalValueFC":"25678","currency":"EURO","unitRateINR":"1760.5","date":"21-Oct-2024","totalValueINR":"2157635.71","totalValueInUsd":"25678","indian_port":"JNPT","hs_no":"29159099","bill_no":"6235984","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FOS SUR MER","supplierAddress":"38 BEACH ROAD # 18-11 SOUTH BEACH T OWER SINGAPORE 189767 SDNF Singapore","customerAddress":"54-A, SIR MATHURADAS VASANJI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"VALPROIC ACID EP","address":"54-A, SIR MATHURADAS VASANJI ROAD","city":"MUMBAI, MAHARASHTRA","supplier":"SANOFI-AVENTIS SINGAPORE PTE LTD","supplierCountry":"FRANCE","foreign_port":"FOS SUR MER","customer":"SANOFI INDIA LIMITED","customerCountry":"INDIA","quantity":"1225.70","actualQuantity":"1225.7","unit":"KGS","unitRateFc":"18.9","totalValueFC":"25680.1","currency":"EURO","unitRateINR":"1760.5","date":"21-Oct-2024","totalValueINR":"2157811.75","totalValueInUsd":"25680.1","indian_port":"JNPT","hs_no":"29159099","bill_no":"6235984","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FOS SUR MER","supplierAddress":"38 BEACH ROAD # 18-11 SOUTH BEACH T OWER SINGAPORE 189767 SDNF Singapore","customerAddress":"54-A, SIR MATHURADAS VASANJI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"SODIUM VALPROATE PH EUR (FOR ORAL SOLUTION) SODIUM VALPROATE PH EUR (FOR ORAL SOLUTION)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"SCI PHARMTECH INC","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"45.6","totalValueFC":"15419.2","currency":"USD","unitRateINR":"4367.2","date":"21-Dec-2024","totalValueINR":"1310155.9","totalValueInUsd":"15419.2","indian_port":"Hyderabad Air","hs_no":"29159099","bill_no":"7385910","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"NO.61,LN.309 HAIHU N. RD LUZHU DIST TAOYUAN CITY SDNF Taiwan","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"SODIUM VALPROATE IP\/PH.EUR SODIUM VALPROATE IP\/PH.EUR","address":"54-A, SIR MATHURADAS VASANJI ROAD","city":"MUMBAI, MAHARASHTRA","supplier":"SANOFI-AVENTIS SINGAPORE PTE LTD","supplierCountry":"FRANCE","foreign_port":"LE HAVRE","customer":"SANOFI INDIA LIMITED","customerCountry":"INDIA","quantity":"4007.22","actualQuantity":"4007.22","unit":"KGS","unitRateFc":"28.8","totalValueFC":"116422.2","currency":"EURO","unitRateINR":"2516.5","date":"27-Mar-2025","totalValueINR":"10084209.2","totalValueInUsd":"116422.2","indian_port":"JNPT","hs_no":"29159099","bill_no":"9141145","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"LE HAVRE","supplierAddress":"38 BEACH ROAD #18-11, SOUTH BEACH T OWER SINGAPORE 189767 Singapore SDNF Singapore","customerAddress":"54-A, SIR MATHURADAS VASANJI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"VALPROIC ACID EP VALPROIC ACID EP","address":"54-A, SIR MATHURADAS VASANJI ROAD","city":"MUMBAI, MAHARASHTRA","supplier":"SANOFI-AVENTIS SINGAPORE PTE LTD","supplierCountry":"FRANCE","foreign_port":"LE HAVRE","customer":"SANOFI INDIA LIMITED","customerCountry":"INDIA","quantity":"1226.00","actualQuantity":"1226","unit":"KGS","unitRateFc":"20.8","totalValueFC":"25749.1","currency":"EURO","unitRateINR":"1819.2","date":"27-Mar-2025","totalValueINR":"2230323.5","totalValueInUsd":"25749.1","indian_port":"JNPT","hs_no":"29159099","bill_no":"9141145","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"LE HAVRE","supplierAddress":"38 BEACH ROAD #18-11, SOUTH BEACH T OWER SINGAPORE 189767 Singapore SDNF Singapore","customerAddress":"54-A, SIR MATHURADAS VASANJI ROAD"}]
04-Jan-2022
29-Apr-2025
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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

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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

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

USFDA APPLICATION NUMBER - 18723

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

USFDA APPLICATION NUMBER - 18723

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

USFDA APPLICATION NUMBER - 18723

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

USFDA APPLICATION NUMBER - 19680

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

USFDA APPLICATION NUMBER - 21168

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

USFDA APPLICATION NUMBER - 21168

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ABOUT THIS PAGE

Looking for 76584-70-8 / Divalproex Sodium API manufacturers, exporters & distributors?

Divalproex Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Divalproex Sodium 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 Divalproex Sodium manufacturer or Divalproex Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Divalproex Sodium manufacturer or Divalproex Sodium supplier.

PharmaCompass also assists you with knowing the Divalproex Sodium API Price utilized in the formulation of products. Divalproex Sodium API Price is not always fixed or binding as the Divalproex Sodium Price is obtained through a variety of data sources. The Divalproex Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Divalproex Sodium

Synonyms

76584-70-8, Valproate semisodium, Epival, Depakote, Sodium divalproate, Semisodium valproate

Cas Number

76584-70-8

About Divalproex Sodium

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.

Natrium hydrogen bis(2-propylvalerat) Manufacturers

A Natrium hydrogen bis(2-propylvalerat) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Natrium hydrogen bis(2-propylvalerat), including repackagers and relabelers. The FDA regulates Natrium hydrogen bis(2-propylvalerat) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Natrium hydrogen bis(2-propylvalerat) 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 Natrium hydrogen bis(2-propylvalerat) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Natrium hydrogen bis(2-propylvalerat) Suppliers

A Natrium hydrogen bis(2-propylvalerat) supplier is an individual or a company that provides Natrium hydrogen bis(2-propylvalerat) active pharmaceutical ingredient (API) or Natrium hydrogen bis(2-propylvalerat) finished formulations upon request. The Natrium hydrogen bis(2-propylvalerat) suppliers may include Natrium hydrogen bis(2-propylvalerat) API manufacturers, exporters, distributors and traders.

click here to find a list of Natrium hydrogen bis(2-propylvalerat) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Natrium hydrogen bis(2-propylvalerat) USDMF

A Natrium hydrogen bis(2-propylvalerat) DMF (Drug Master File) is a document detailing the whole manufacturing process of Natrium hydrogen bis(2-propylvalerat) active pharmaceutical ingredient (API) in detail. Different forms of Natrium hydrogen bis(2-propylvalerat) DMFs exist exist since differing nations have different regulations, such as Natrium hydrogen bis(2-propylvalerat) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Natrium hydrogen bis(2-propylvalerat) DMF submitted to regulatory agencies in the US is known as a USDMF. Natrium hydrogen bis(2-propylvalerat) USDMF includes data on Natrium hydrogen bis(2-propylvalerat)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Natrium hydrogen bis(2-propylvalerat) USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Natrium hydrogen bis(2-propylvalerat) suppliers with USDMF on PharmaCompass.

Natrium hydrogen bis(2-propylvalerat) JDMF

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 Natrium hydrogen bis(2-propylvalerat) Drug Master File in Japan (Natrium hydrogen bis(2-propylvalerat) JDMF) empowers Natrium hydrogen bis(2-propylvalerat) 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 Natrium hydrogen bis(2-propylvalerat) JDMF during the approval evaluation for pharmaceutical products. At the time of Natrium hydrogen bis(2-propylvalerat) 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 Natrium hydrogen bis(2-propylvalerat) suppliers with JDMF on PharmaCompass.

Natrium hydrogen bis(2-propylvalerat) KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Natrium hydrogen bis(2-propylvalerat) Drug Master File in Korea (Natrium hydrogen bis(2-propylvalerat) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Natrium hydrogen bis(2-propylvalerat). The MFDS reviews the Natrium hydrogen bis(2-propylvalerat) KDMF as part of the drug registration process and uses the information provided in the Natrium hydrogen bis(2-propylvalerat) KDMF to evaluate the safety and efficacy of the drug.

After submitting a Natrium hydrogen bis(2-propylvalerat) 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 Natrium hydrogen bis(2-propylvalerat) API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Natrium hydrogen bis(2-propylvalerat) suppliers with KDMF on PharmaCompass.

Natrium hydrogen bis(2-propylvalerat) CEP

A Natrium hydrogen bis(2-propylvalerat) CEP of the European Pharmacopoeia monograph is often referred to as a Natrium hydrogen bis(2-propylvalerat) Certificate of Suitability (COS). The purpose of a Natrium hydrogen bis(2-propylvalerat) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Natrium hydrogen bis(2-propylvalerat) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Natrium hydrogen bis(2-propylvalerat) to their clients by showing that a Natrium hydrogen bis(2-propylvalerat) CEP has been issued for it. The manufacturer submits a Natrium hydrogen bis(2-propylvalerat) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Natrium hydrogen bis(2-propylvalerat) CEP holder for the record. Additionally, the data presented in the Natrium hydrogen bis(2-propylvalerat) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Natrium hydrogen bis(2-propylvalerat) DMF.

A Natrium hydrogen bis(2-propylvalerat) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Natrium hydrogen bis(2-propylvalerat) 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 Natrium hydrogen bis(2-propylvalerat) suppliers with CEP (COS) on PharmaCompass.

Natrium hydrogen bis(2-propylvalerat) WC

A Natrium hydrogen bis(2-propylvalerat) written confirmation (Natrium hydrogen bis(2-propylvalerat) WC) is an official document issued by a regulatory agency to a Natrium hydrogen bis(2-propylvalerat) manufacturer, verifying that the manufacturing facility of a Natrium hydrogen bis(2-propylvalerat) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Natrium hydrogen bis(2-propylvalerat) APIs or Natrium hydrogen bis(2-propylvalerat) finished pharmaceutical products to another nation, regulatory agencies frequently require a Natrium hydrogen bis(2-propylvalerat) WC (written confirmation) as part of the regulatory process.

click here to find a list of Natrium hydrogen bis(2-propylvalerat) suppliers with Written Confirmation (WC) on PharmaCompass.

Natrium hydrogen bis(2-propylvalerat) NDC

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 Natrium hydrogen bis(2-propylvalerat) as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Natrium hydrogen bis(2-propylvalerat) API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Natrium hydrogen bis(2-propylvalerat) 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Natrium hydrogen bis(2-propylvalerat) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Natrium hydrogen bis(2-propylvalerat) NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Natrium hydrogen bis(2-propylvalerat) suppliers with NDC on PharmaCompass.

Natrium hydrogen bis(2-propylvalerat) GMP

Natrium hydrogen bis(2-propylvalerat) 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 Natrium hydrogen bis(2-propylvalerat) 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 Natrium hydrogen bis(2-propylvalerat) GMP manufacturer or Natrium hydrogen bis(2-propylvalerat) GMP API supplier for your needs.

Natrium hydrogen bis(2-propylvalerat) CoA

A Natrium hydrogen bis(2-propylvalerat) CoA (Certificate of Analysis) is a formal document that attests to Natrium hydrogen bis(2-propylvalerat)'s compliance with Natrium hydrogen bis(2-propylvalerat) specifications and serves as a tool for batch-level quality control.

Natrium hydrogen bis(2-propylvalerat) CoA mostly includes findings from lab analyses of a specific batch. For each Natrium hydrogen bis(2-propylvalerat) 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.

Natrium hydrogen bis(2-propylvalerat) may be tested according to a variety of international standards, such as European Pharmacopoeia (Natrium hydrogen bis(2-propylvalerat) EP), Natrium hydrogen bis(2-propylvalerat) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Natrium hydrogen bis(2-propylvalerat) USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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