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    Chemistry

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    Also known as: 77337-73-6, Campral, Campral ec, Alcomed, Sobriol, Aotal
    Molecular Formula
    C10H20CaN2O8S2
    Molecular Weight
    400.5  g/mol
    InChI Key
    BUVGWDNTAWHSKI-UHFFFAOYSA-L
    FDA UNII
    59375N1D0U
    Acamprosate Calcium
    Structural analog of taurine that is used for the prevention of relapse in individuals with ALCOHOLISM.
    1 2D Structure

    Acamprosate Calcium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    calcium;3-acetamidopropane-1-sulfonate
    2.1.2 InChI
    InChI=1S/2C5H11NO4S.Ca/c2*1-5(7)6-3-2-4-11(8,9)10;/h2*2-4H2,1H3,(H,6,7)(H,8,9,10);/q;;+2/p-2
    2.1.3 InChI Key
    BUVGWDNTAWHSKI-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    CC(=O)NCCCS(=O)(=O)[O-].CC(=O)NCCCS(=O)(=O)[O-].[Ca+2]
    2.2 Other Identifiers
    2.2.1 UNII
    59375N1D0U
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acamprosate

    2. Acamprostate

    3. Acetyl Homotaurinate, Calcium

    4. Acetylhomotaurinate, Calcium

    5. Acetylhomotaurine, Calcium

    6. Acetylhomotaurine, Sodium

    7. Aotal

    8. Calcium Acetyl Homotaurinate

    9. Calcium Acetylhomotaurinate

    10. Calcium Acetylhomotaurine

    11. Campral

    12. Campral Ec

    13. N Acetylhomotaurine

    14. N Acetylhomotaurine, Monolithium Salt

    15. N Acetylhomotaurine, Monopotassium Salt

    16. N Acetylhomotaurine, Monosodium Salt

    17. N-acetylhomotaurine

    18. N-acetylhomotaurine, Calcium (2:1) Salt

    19. N-acetylhomotaurine, Magnesium (2:1) Salt

    20. N-acetylhomotaurine, Monolithium Salt

    21. N-acetylhomotaurine, Monopotassium Salt

    22. N-acetylhomotaurine, Monosodium Salt

    23. N-acetylhomotaurine, Zinc (2:1) Salt

    24. Regtect

    25. Sodium Acetylhomotaurine

    26. Zulex

    2.3.2 Depositor-Supplied Synonyms

    1. 77337-73-6

    2. Campral

    3. Campral Ec

    4. Alcomed

    5. Sobriol

    6. Aotal

    7. Calcium 3-acetamidopropane-1-sulfonate

    8. Calcium Acetylhomotaurinate

    9. Acamprosate Calcium [usan]

    10. Calcium N-acetylhomotaurinate

    11. Calcium 3-(acetylamino)propane-1-sulfonate

    12. 1-propanesulfonic Acid, 3-(acetylamino)-, Calcium Salt (2:1)

    13. Acamprosate (calcium)

    14. Nsc-759186

    15. Chebi:51042

    16. Sn-102

    17. 59375n1d0u

    18. Calcium Bis(3-acetamidopropane-1-sulfonate)

    19. Dsstox_cid_27529

    20. Dsstox_rid_82399

    21. Dsstox_gsid_47529

    22. 77337-73-6 (calcium Salt); 77337-76-9 (free Acid).

    23. Calcium Acamprosate

    24. Cas-77337-73-6

    25. Calcium(2+) 3-(acetylamino)propanesulphonate

    26. Ncgc00167462-01

    27. Einecs 278-665-3

    28. N-acetylhomotaurine Calcium

    29. Unii-59375n1d0u

    30. Campral (tn)

    31. Regtect (tn)

    32. Calcium;3-acetamidopropane-1-sulfonate

    33. Calcium 3-(acetylamino)propanesulphonate

    34. Acamprosate Calcium- Bio-x

    35. Schembl137771

    36. 3-(acetylamino)-1-propanesulfonic Acid Calcium Salt

    37. Acamprosate Calcium [mi]

    38. Chembl2068724

    39. Dtxsid6047529

    40. Acamprosate Calcium (jan/usan)

    41. Acamprosate Calcium [jan]

    42. Hms3264j11

    43. Hms3713l22

    44. Pharmakon1600-01505711

    45. Acamprosate Calcium [mart.]

    46. Tox21_112466

    47. Tox21_302606

    48. Acamprosate Calcium [usp-rs]

    49. Acamprosate Calcium [who-dd]

    50. Mfcd00886588

    51. Nsc759186

    52. Akos015895192

    53. Ab07649

    54. Ac-5599

    55. Calcium 3-acetamido-1-propanesulfonate

    56. Ccg-213526

    57. Ks-5292

    58. Nsc 759186

    59. Acamprosate Calcium [orange Book]

    60. Ncgc00256899-01

    61. Acamprosate Calcium [ep Monograph]

    62. Ba164134

    63. Acamprosate Calcium [usp Monograph]

    64. Db-056209

    65. Ft-0621712

    66. 3-acetamido-1-propanesulfonate Calcium

    67. 3-acetamido-1-propanesulphonate Calcium

    68. D02780

    69. T71327

    70. 3-acetamido-1-propanesulfonic Acid Calcium Salt

    71. A839056

    72. Calcium 3-(acetylamino)propane-1-sulphonate

    73. Q27122289

    74. 3-(acetylamino)-1-propanesulfonic Acid Hemicalcium Salt

    75. Z1696861853

    76. 5-methoxy-2-methyl-1-propyl-1h-indole-3-carboxylicacid

    77. 1-propanesulfonic Acid, 3-(acetylamino)-, Calcium Salt (2:1)

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 400.5 g/mol
    Molecular Formula C10H20CaN2O8S2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count6
    Exact Mass400.0286988 g/mol
    Monoisotopic Mass400.0286988 g/mol
    Topological Polar Surface Area189 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity202
    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 2  
    Drug NameAcamprosate calcium
    Drug LabelCampral (acamprosate calcium) is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analo...
    Active IngredientAcamprosate calcium
    Dosage FormTablet, delayed release
    RouteOral
    Strength333mg
    Market StatusPrescription
    CompanyMylan Pharms; Glenmark Generics; Barr Labs Div Teva

    2 of 2  
    Drug NameAcamprosate calcium
    Drug LabelCampral (acamprosate calcium) is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analo...
    Active IngredientAcamprosate calcium
    Dosage FormTablet, delayed release
    RouteOral
    Strength333mg
    Market StatusPrescription
    CompanyMylan Pharms; Glenmark Generics; Barr Labs Div Teva

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Alcohol Deterrents

    Substances interfering with the metabolism of ethyl alcohol, causing unpleasant side effects thought to discourage the drinking of alcoholic beverages. Alcohol deterrents are used in the treatment of alcoholism. (See all compounds classified as Alcohol Deterrents.)

    API Reference Price

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RIVOLTANA Km 6\/7 20053 RODANO (MI) SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735151400,"product":"ACAMPROSATE CALCIUM 30 ACAMPROSATE CALCIUM 30","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"ANGELINI PHARMA S P A","supplierCountry":"ITALY","foreign_port":"ANCONA","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"1371.00","actualQuantity":"1371","unit":"KGS","unitRateFc":"340","totalValueFC":"493740.1","currency":"EURO","unitRateINR":"30600","date":"26-Dec-2024","totalValueINR":"41952600","totalValueInUsd":"493740.1","indian_port":"Bombay Air","hs_no":"29241900","bill_no":"7455963","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ANCONA","supplierAddress":"Viale Amelia, 70 00181 Roma - Italy SDNF SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739557800,"product":"ACAMPROSATE CALCIUM ( IMPORT DRUGS FOR THE PURPOSES OF EXAMINATION,TEST OR ANALYSIS LIC NO. SW\/OD\/11\/2024\/000006708 DT.ACAMPROSATE CALCIUM","address":"ASTER FLAT NO 402 REGENCY GARDENS,","city":"KHARGHAR,MAHARASHTRA","supplier":"OLON S P A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"PROSFORA TECHNOLOGIES PRIVATE LTD","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"188.8","totalValueFC":"14390.4","currency":"EURO","unitRateINR":"16686","date":"15-Feb-2025","totalValueINR":"1251450","totalValueInUsd":"14390.4","indian_port":"Bombay Air","hs_no":"29241900","bill_no":"8380839","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STRADA RIVOLTANA KM 6\/7 20090 RODANO (MI) SDNF ITALY","customerAddress":"ASTER FLAT NO 402 REGENCY GARDENS,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749234600,"product":"ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM MICRONIZED ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM MICRONIZED","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"OLON S P A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"1630.00","actualQuantity":"1630","unit":"KGS","unitRateFc":"180","totalValueFC":"296215.6","currency":"USD","unitRateINR":"15615","date":"07-Jun-2025","totalValueINR":"25452450","totalValueInUsd":"296215.6","indian_port":"Bombay Air","hs_no":"29241990","bill_no":"2516634","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"STR. RIVOLTANA Km 6\/7 20053 RODANO (MI) ITALY SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749753000,"product":"ACAMPROSATE CALCIUM- ACAMPROSATE CALCIUM 30 ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM 30","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"ANGELINI PHARMA S P A","supplierCountry":"ITALY","foreign_port":"ROME","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"2512.60","actualQuantity":"2512.6","unit":"KGS","unitRateFc":"414.4","totalValueFC":"1051119.9","currency":"EURO","unitRateINR":"35946","date":"13-Jun-2025","totalValueINR":"90317919.6","totalValueInUsd":"1051119.9","indian_port":"Bombay Air","hs_no":"29241990","bill_no":"2638480","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROME","supplierAddress":"Viale Amelia, 70 00181 Roma - Italy SDNF SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753381800,"product":"ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM 30 ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM 30","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"ANGELINI PHARMA S P A","supplierCountry":"ITALY","foreign_port":"ANCONA","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"833.00","actualQuantity":"833","unit":"KGS","unitRateFc":"445","totalValueFC":"373856.3","currency":"EURO","unitRateINR":"38627","date":"25-Jul-2025","totalValueINR":"32176291","totalValueInUsd":"373856.3","indian_port":"Bombay Air","hs_no":"29241990","bill_no":"3485433","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ANCONA","supplierAddress":"Viale Amelia, 70 00181 Roma - Italy SDNF SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758652200,"product":"ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM 30 ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM 30","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"ANGELINI PHARMA S P A","supplierCountry":"ITALY","foreign_port":"ANCONA","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"2861.10","actualQuantity":"2861.1","unit":"KGS","unitRateFc":"452.5","totalValueFC":"1303148.4","currency":"EURO","unitRateINR":"40204","date":"24-Sep-2025","totalValueINR":"115027664.4","totalValueInUsd":"1303148.4","indian_port":"Bombay Air","hs_no":"29241990","bill_no":"4697946","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ANCONA","supplierAddress":"Viale Amelia, 70 00181 Roma - Italy SDNF SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1763749800,"product":"ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM 30 ACAMPROSATE CALCIUM-ACAMPROSATE CALCIUM 30","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"ANGELINI PHARMA S P A","supplierCountry":"ITALY","foreign_port":"ANCONA","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"554.50","actualQuantity":"554.5","unit":"KGS","unitRateFc":"443.5","totalValueFC":"247619.4","currency":"EURO","unitRateINR":"39691","date":"22-Nov-2025","totalValueINR":"22008659.5","totalValueInUsd":"247619.4","indian_port":"Bombay Air","hs_no":"29241990","bill_no":"6","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"ANCONA","supplierAddress":"Viale Amelia, 70 00181 Roma - Italy SDNF SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766428200,"product":"ACAMPROSATE CALCIUM -ACAMPROSATE CALCIUM MICRONIZED(FOR PHARMACEUTICAL USE ONLY.)ACAMPROSATE CALCIUM -ACAMPROSATE CALCIUM MICRONIZED","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"OLON S P A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"1080.00","actualQuantity":"1080","unit":"KGS","unitRateFc":"180","totalValueFC":"197098","currency":"USD","unitRateINR":"16425","date":"23-Dec-2025","totalValueINR":"17739000","totalValueInUsd":"197098","indian_port":"Bombay Air","hs_no":"29241990","bill_no":"1790000000","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN","supplierAddress":"STR. RIVOLTANA Km 6\/7 20053 RODANO (MI) ITALY SDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"}]
    05-Jan-2022
    08-Jan-2026
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    Related Excipient Companies

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    Excipients by Applications

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    Coating Systems & Additives

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    Fillers, Diluents & Binders

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    01

    Nanjing Well Pharmaceutical

    China
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Brand Name : Polyethylene Glycol 400

    Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

    Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.

    Pharmacopoeia Ref : ChP/USP/EP

    Technical Specs : NA

    Ingredient(s) : Polyethylene Glycol 400

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    Nanjing Well Polyethylene Glycol 400 NF

    Excipients Web Link

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    02

    Boai NKY Pharmaceuticals Ltd

    China
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Capsule, Tablet

    Grade : Oral (Pharma Grade)

    Category : Fillers, Diluents & Binders

    Brand Name : KoVidone® K30

    Application : Fillers, Diluents & Binders

    Excipient Details : KoVidone® K30 is used as a binder for tablets and capsules.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Povidone K30

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    KoVidone® K30

    Excipients Web Link

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    03

    Gangwal Healthcare

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Category : Co-Processed Excipients, Fillers, Diluents & Binders

    Brand Name : ProBlend®

    Application : Co-Processed Excipients, Fillers, Diluents & Binders

    Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.

    Pharmacopoeia Ref : USP-NF,BP,EP,IP

    Technical Specs : NA

    Ingredient(s) : Microcrystalline Cellulose Excipients

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    Gangwal Healthcare ProBlend®

    Excipients Web Link

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    04

    Boai NKY Pharmaceuticals Ltd

    China
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Capsule, Suspension, Tablet

    Grade : Oral (Pharma Grade)

    Category : Fillers, Diluents & Binders, Thickeners and Stabilizers

    Brand Name : KoVidone® K90

    Application : Fillers, Diluents & Binders, Thickeners and Stabilizers

    Excipient Details : KoVidone® K90 acts as a binder for tablets and capsules. It is also used as thickener and stabilizer in liquid dosage forms such as suspension.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Povidone K90

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    KoVidone® K90

    Excipients Web Link

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    05

    Gangwal Healthcare

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Dosage Form : Tablet

    Grade : Oral

    Category : Co-Processed Excipients, Fillers, Diluents & Binders

    Brand Name : Microlose™

    Application : Co-Processed Excipients, Fillers, Diluents & Binders

    Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.

    Pharmacopoeia Ref : USP-NF,BP,EP,IP

    Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%

    Ingredient(s) : Lactose Monohydrate

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    Gangwal Healthcare Microlose™

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    06

    Sigachi Industries

    India
    BePharma
    Not Confirmed
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    07

    Microlex e.U

    Austria
    BePharma
    Not Confirmed
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    08

    Keval Exports

    India
    BePharma
    Not Confirmed
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    09

    Nitika Pharmaceutical Specialities

    India
    BePharma
    Not Confirmed
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    10

    Ulanqab Kema New Material

    China
    BePharma
    Not Confirmed
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    01

    Pluviaendo

    Turkey
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    02

    Pluviaendo

    Turkey
    BePharma
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    03

    Microlex e.U

    Austria
    BePharma
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    04

    Aeon Procare

    India
    BePharma
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    05

    Shanghai Shenmei Pharmaceutical Te...

    China
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    Nitika Pharmaceutical Specialities

    India
    BePharma
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    Silverline Chemicals

    India
    BePharma
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    08

    Shanghai Welltone Material Technol...

    China
    BePharma
    Not Confirmed
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    09

    Neelkanth MineChem

    India
    BePharma
    Not Confirmed
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    10

    Microlex e.U

    Austria
    BePharma
    Not Confirmed
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    Granulation

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    ABOUT THIS PAGE

    Looking for 77337-73-6 / Acamprosate Calcium API manufacturers, exporters & distributors?

    Acamprosate Calcium manufacturers, exporters & distributors 1

    16

    PharmaCompass offers a list of Acamprosate Calcium 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 Acamprosate Calcium manufacturer or Acamprosate Calcium supplier for your needs.

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

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

    API | Excipient name

    Acamprosate Calcium

    Synonyms

    77337-73-6, Campral, Campral ec, Alcomed, Sobriol, Aotal

    Cas Number

    77337-73-6

    Unique Ingredient Identifier (UNII)

    59375N1D0U

    About Acamprosate Calcium

    Structural analog of taurine that is used for the prevention of relapse in individuals with ALCOHOLISM.

    Zulex Manufacturers

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

    Zulex Suppliers

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

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

    Zulex USDMF

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

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

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

    Zulex KDMF

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

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

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

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

    Zulex CEP

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

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

    Zulex WC

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

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

    Zulex 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 Zulex as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Zulex GMP

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

    Zulex CoA

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

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

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