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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]

    API Reference Price

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D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0004","unit":"KGS","unitRateFc":"221900","totalValueFC":"92.4","currency":"USD","unitRateINR":"19254950","date":"09-May-2024","totalValueINR":"7701.98","totalValueInUsd":"92.4","indian_port":"Hyderabad Air","hs_no":"29159099","bill_no":"3408524","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"VALPROIC ACID RELATED COMPOUND K(QTY: 4 X 0.1GMS, VALUE USD:28.69\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0004","unit":"KGS","unitRateFc":"286900","totalValueFC":"119.5","currency":"USD","unitRateINR":"24895225","date":"09-May-2024","totalValueINR":"9958.09","totalValueInUsd":"119.5","indian_port":"Hyderabad Air","hs_no":"29159099","bill_no":"3408524","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726684200,"product":"VALPROIC ACID","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"SCI PHARMTECH INC","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"RUBICON RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"27.00","actualQuantity":"27","unit":"KGS","unitRateFc":"115","totalValueFC":"3145.7","currency":"USD","unitRateINR":"9763.5","date":"19-Sep-2024","totalValueINR":"263614.5","totalValueInUsd":"3145.7","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"5685540","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"NO.61, LN. 309, HAIHU N. 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 LTD","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":1729881000,"product":"RELEVANT BULK DRUG VALPROIC ACID","address":"1\/5, SANTOSH COMPLEX, ARMUGAM","city":"BANGALORE , KARNATAKA","supplier":"KATWIJK CHEMIE BV","supplierCountry":"NETHERLANDS","foreign_port":"ROTTERDAM","customer":"MAIVA PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"79","totalValueFC":"8739","currency":"EURO","unitRateINR":"7343.1","date":"26-Oct-2024","totalValueINR":"734305","totalValueInUsd":"8739","indian_port":"Madras Sea","hs_no":"29242990","bill_no":"6364369","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"SNIJDERSTRAAT 6 2222 BA KATWIJK THE NETHERLANDS NETHERLANDS","customerAddress":"1\/5, SANTOSH COMPLEX, ARMUGAM"},{"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 LTD","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 LTD","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
    27-May-2025
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    DRUG PRODUCT COMPOSITIONS

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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.

    Depakine Manufacturers

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

    Depakine Suppliers

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

    click here to find a list of Depakine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Depakine USDMF

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

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

    click here to find a list of Depakine suppliers with USDMF on PharmaCompass.

    Depakine 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 Depakine Drug Master File in Japan (Depakine JDMF) empowers Depakine 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 Depakine JDMF during the approval evaluation for pharmaceutical products. At the time of Depakine 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 Depakine suppliers with JDMF on PharmaCompass.

    Depakine KDMF

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

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

    After submitting a Depakine 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 Depakine API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Depakine suppliers with KDMF on PharmaCompass.

    Depakine CEP

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

    A Depakine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Depakine 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 Depakine suppliers with CEP (COS) on PharmaCompass.

    Depakine WC

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

    click here to find a list of Depakine suppliers with Written Confirmation (WC) on PharmaCompass.

    Depakine 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 Depakine as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Depakine 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 Depakine 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 Depakine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Depakine NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Depakine suppliers with NDC on PharmaCompass.

    Depakine GMP

    Depakine 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 Depakine 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 Depakine GMP manufacturer or Depakine GMP API supplier for your needs.

    Depakine CoA

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

    Depakine CoA mostly includes findings from lab analyses of a specific batch. For each Depakine 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.

    Depakine may be tested according to a variety of international standards, such as European Pharmacopoeia (Depakine EP), Depakine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Depakine 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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