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    Chemistry

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    Also known as: Potassium clavulanate, 61177-45-5, Clavulanic acid potassium salt, Brl 14151k, Clavulanate (potassium), Q42omw3at8
    Molecular Formula
    C8H8KNO5
    Molecular Weight
    237.25  g/mol
    InChI Key
    ABVRVIZBZKUTMK-JSYANWSFSA-M
    FDA UNII
    Q42OMW3AT8
    Clavulanic Acid
    A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.
    1 2D Structure

    Clavulanic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    potassium;(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
    2.1.2 InChI
    InChI=1S/C8H9NO5.K/c10-2-1-4-7(8(12)13)9-5(11)3-6(9)14-4;/h1,6-7,10H,2-3H2,(H,12,13);/q;+1/p-1/b4-1-;/t6-,7-;/m1./s1
    2.1.3 InChI Key
    ABVRVIZBZKUTMK-JSYANWSFSA-M
    2.1.4 Canonical SMILES
    C1C2N(C1=O)C(C(=CCO)O2)C(=O)[O-].[K+]
    2.1.5 Isomeric SMILES
    C1[C@@H]2N(C1=O)[C@H](/C(=C/CO)/O2)C(=O)[O-].[K+]
    2.2 Other Identifiers
    2.2.1 UNII
    Q42OMW3AT8
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Brl 14151

    2. Brl-14151

    3. Brl14151

    4. Clavulanate

    5. Clavulanate, Potassium

    6. Clavulanate, Sodium

    7. Clavulanic Acid

    8. Clavulanic Acid, Monopotassium Salt

    9. Clavulanic Acid, Monosodium Salt

    10. Mm 14151

    11. Mm-14151

    12. Mm14151

    13. Potassium Clavulanate

    14. Potassium, Clavulanate

    15. Sodium Clavulanate

    2.3.2 Depositor-Supplied Synonyms

    1. Potassium Clavulanate

    2. 61177-45-5

    3. Clavulanic Acid Potassium Salt

    4. Brl 14151k

    5. Clavulanate (potassium)

    6. Q42omw3at8

    7. Chebi:85264

    8. Brl-14151k

    9. Potassium (2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

    10. Potassium (z)-(2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

    11. Potassium;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

    12. Amonate

    13. Potassium (2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

    14. Clavulansaeure Kaliumsalz

    15. Einecs 262-640-9

    16. Unii-q42omw3at8

    17. Potassium Clavlanate

    18. Clavulanate Potassium [usan:usp:jan]

    19. Chembl1003

    20. Schembl203411

    21. Clavulanic Acid Potassium

    22. Hy-a0256a

    23. Dtxsid60210067

    24. Hms3715b13

    25. Clavulanate Potassium (jp17/usp)

    26. Potassium Clavulanate [jan]

    27. Bcp13548

    28. Clavulanate Potassium [usan]

    29. Clavulanate Potassium [vandf]

    30. Potassium Clavulanate [mart.]

    31. Potassium Clavulanate Cellulose(1:1)

    32. Akos015961326

    33. Clavulanate Potassium [who-dd]

    34. Ccg-221126

    35. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2alpha,3z,5alpha))-

    36. Ac-13551

    37. Bp-30181

    38. Clavulanate Potassium [green Book]

    39. Potassium (2r-(2alpha,3z,5alpha))-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

    40. Clavulanate Potassium [orange Book]

    41. Potassium Clavulanate [ep Monograph]

    42. Clavulanate Potassium [usp Monograph]

    43. Cs-0019771

    44. Augmentin Component Clavulanate Potassium

    45. C-6660

    46. Clavulox Component Clavulanate Potassium

    47. D02370

    48. D84066

    49. Timentin Component Clavulanate Potassium

    50. A833076

    51. Clavulanate Potassium Component Of Augmentin

    52. Clavulanate Potassium Component Of Clavulox

    53. Clavulanate Potassium Component Of Timentin

    54. Clavulanic Acid (as Clavulanate Potassium)

    55. Clavulanic Acid Potassium 100 Microg/ml In Water

    56. W-105420

    57. Clavulanate Potassium+microcrystalline Cellulose(1:1)

    58. Potassium Clavulanate (40%) : Silicon Dioxide Mixture

    59. Q27158444

    60. Potassium Clavulanate (50%) : Microcrystalline Cellulose

    61. Clavulanate Potassium Salt, Antibiotic For Culture Media Use Only

    62. Potassium Clavulanate - 1:1 Mixture With Cellulose, Antibiotic For Culture Media Use Only

    63. (2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2beta-carboxylic Acid Potassium Salt

    64. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2.alpha.,3z,5.alpha.))-

    65. Potassium (2r,3z,5r)-3-(2-oxidanylethylidene)-7-oxidanylidene-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

    66. Potassium (2r,5r,z)- 3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

    67. Potassium(2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 237.25 g/mol
    Molecular Formula C8H8KNO5
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass237.00395384 g/mol
    Monoisotopic Mass237.00395384 g/mol
    Topological Polar Surface Area89.9 Ų
    Heavy Atom Count15
    Formal Charge0
    Complexity329
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    beta-Lactamase Inhibitors

    Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)

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ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734373800,"product":"POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOS E)(1:1) IP (4000 KGA)(GCOD PTE.LTD.) IUPAC NAME:POTASSIUM(2","address":"DARABSHAW HOUSE LEVEL 1 SHOORJI","city":"MUMBAI","supplier":"N\/A","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"NHAVA SHEVA BUSINESS PARK PRIVATE LIMITED","customerCountry":"INDIA","quantity":"9436.00","actualQuantity":"9436","unit":"KGS","unitRateFc":"77.6","totalValueFC":"737866.9","currency":"USD","unitRateINR":"6644.3","date":"17-Dec-2024","totalValueINR":"62695800","totalValueInUsd":"737866.9","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29419090","bill_no":"7286137","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"DARABSHAW HOUSE LEVEL 1 SHOORJI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734460200,"product":"POTASSIUM CLAVULANATE DILUTED (POTASSIUM CLAVULANATE WITH MICROCRYSTALLINE CELLULOSE)(1:1)(I.P.POTASSIUM CLAVULANATE DILUTED (POTASSIUM CLAVULANATE WITH SI","address":"13, KAILASH DARSHAN, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"ZHUHAI UNITED LABORATORIES CO ., LTD.","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"ORBIT LIFESCIENCE","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"83","totalValueFC":"250995.7","currency":"USD","unitRateINR":"7109","date":"18-Dec-2024","totalValueINR":"21326850","totalValueInUsd":"250995.7","indian_port":"JNPT","hs_no":"29419019","bill_no":"7320894","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"XINGANG (CHINA)","supplierAddress":"., 7-8 FLOOR,NEW OFFICE OF ZHUHAI U NITED LABORATORIES,NO.2428 ANJI ROA D,SANZAO TOWN,JINWAN DISTRICT-ZHUHA CHINA","customerAddress":"13, KAILASH DARSHAN, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734546600,"product":"AMOXICILLIN SODIUM WITH POTASSIUM CLAVULANATE (BLEND STERILE) (5:1)AMOXICILLIN SODIUM WITH POTASSIUM CLAVULANATE (BLEND STERILE","address":"414,SHRIKANT CHAMBERS,","city":"CHEMBUR,MUMBAI,MAHARASHTRA","supplier":"JOINT FORCE PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"NANNING","customer":"P K PHARMATECH ","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"190","totalValueFC":"47880.7","currency":"USD","unitRateINR":"16273.5","date":"19-Dec-2024","totalValueINR":"4068375","totalValueInUsd":"47880.7","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"7341335","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"NANNING","supplierAddress":"RM.1110A, TOWER A, HUNG HOM COMMERC IAL CENTER 39 MA TAU WAI ROAD, HUNG HOM, KOWLOON, HK HONG KONG","customerAddress":"414,SHRIKANT CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734546600,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHSILICON DIOXIDE) (1:1) IP (SYLOID)POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITH","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"M\/S JOINT FORCE PHARMACEUTICAL LIMITED","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"85.4","totalValueFC":"10763.1","currency":"USD","unitRateINR":"7316.2","date":"19-Dec-2024","totalValueINR":"914527.88","totalValueInUsd":"10763.1","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"7342022","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Diluted","supplierPort":"CHENGDU","supplierAddress":"RM.1110A TOWER A, HUNG HOM COMMERCIAL CENTER 39 MA TAU WAI ROAD, HUNG HOM, KOWLOON HK HK","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHMICROCRYSTALLINE CELLULOSE) (1:1) I.PPOTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITH","address":"414,SHRIKANT CHAMBERS,","city":"CHEMBUR,MUMBAI,MAHARASHTRA","supplier":"JOINT FORCE PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"GUIYANG","customer":"P K PHARMATECH ","customerCountry":"INDIA","quantity":"2310.00","actualQuantity":"2310","unit":"KGS","unitRateFc":"84.4","totalValueFC":"197251.4","currency":"USD","unitRateINR":"7255.5","date":"23-Dec-2024","totalValueINR":"16760249.92","totalValueInUsd":"197251.4","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"7403953","productDescription":"API","marketType":"REGULATED 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LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"81.3","totalValueFC":"41094","currency":"USD","unitRateINR":"6983.4","date":"23-Dec-2024","totalValueINR":"3491718.75","totalValueInUsd":"41094","indian_port":"Madras Air","hs_no":"29419090","bill_no":"7412423","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"CHENGDU","supplierAddress":"RM1110A,TOWER A,HUNG HOM COMMERCIAL CENTER,39 MA TAU WAI ROAD, HUNG HOM KOWLOON HONG KONG","customerAddress":"25, PULIYUR II MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHSILICON DIOXIDE) )1:1) IPPOTASSIUM CLAVULANATE DILUTED IP","address":"PLOT NO.28\/6, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"JOINT FORCE PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATI","customerCountry":"INDIA","quantity":"50.06","actualQuantity":"50.06","unit":"KGS","unitRateFc":"88.7","totalValueFC":"4493.8","currency":"USD","unitRateINR":"7627.6","date":"23-Dec-2024","totalValueINR":"381837.52","totalValueInUsd":"4493.8","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"7418662","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Diluted","supplierPort":"CHENGDU","supplierAddress":"RM. 1110A, TOWER A, HUNG HOM COMMERCIAL CENTER 39 MA TAU WAI ROAD, HUNG HOM, KOWLOON HK","customerAddress":"PLOT NO.28\/6, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734978600,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHMICROCRYSTALLINE CELLULOSE) (1:1) I.PPOTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITH","address":"VILLAGE LOHARAN,","city":"","supplier":"JOINT FORCE PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"GUIYANG","customer":"CHIROS PHARMA","customerCountry":"INDIA","quantity":"174.39","actualQuantity":"174.39","unit":"KGS","unitRateFc":"84.4","totalValueFC":"14891.2","currency":"USD","unitRateINR":"7255.5","date":"24-Dec-2024","totalValueINR":"1265289.72","totalValueInUsd":"14891.2","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"7438819","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"GUIYANG","supplierAddress":"RM 1110A TOWER A,HUNG HOM COMMERCIA L CENTER,39 MA TAU WAI ROAD HUNG HO M KOWLOON HK Hong Kong, , HONG KONG HONG KONG","customerAddress":"VILLAGE LOHARAN,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734978600,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHMICROCRYSTALLINE CELLULOSE) (1:1) 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Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735324200,"product":"POTASSIUM CLAVULANATE MICROCRYSTALLINE CELLULOSE 1:1 BLEND BULK DRUGS","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"GSK","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON GATWAY PORT","customer":"MEDREICH","customerCountry":"INDIA","quantity":"2431.40","actualQuantity":"2431.4","unit":"KGS","unitRateFc":"141.3","totalValueFC":"347399.9","currency":"USD","unitRateINR":"12140.4","date":"28-Dec-2024","totalValueINR":"29518217.19","totalValueInUsd":"347399.9","indian_port":"Madras Sea","hs_no":"29411090","bill_no":"7500553","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Crystalline","supplierPort":"LONDON GATWAY PORT","supplierAddress":"79 NEW OXFORD STREET LONDON WC1A 1DG UNITED KINGDOM SDNF","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735497000,"product":"HYDROXYUREA HYD-6000 POTASSIUM CLAVULANATE","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"MAO CONSULTING AND ","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"4000.00","actualQuantity":"4000","unit":"KGS","unitRateFc":"66","totalValueFC":"267048","currency":"USD","unitRateINR":"5672.7","date":"30-Dec-2024","totalValueINR":"22690800","totalValueInUsd":"267048","indian_port":"Madras Sea","hs_no":"29349990","bill_no":"7519775","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"1441 BROADWAY,SUITE#2402 NEW YORK, NY 10018 USA UNITED STATES","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API 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MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"XINGANG","supplierAddress":"N\/A","customerAddress":"302-CEEJAY HOUSE, SHIV SAGAR ESTATE, DR.ANNIE BESANT ROAD"}]
    01-Jan-2021
    30-Dec-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50564

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    DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50564

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    DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

    USFDA APPLICATION NUMBER - 50575

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    DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

    USFDA APPLICATION NUMBER - 50575

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    DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE

    USFDA APPLICATION NUMBER - 50720

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    DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

    USFDA APPLICATION NUMBER - 50725

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    DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

    USFDA APPLICATION NUMBER - 50725

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    DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

    USFDA APPLICATION NUMBER - 50755

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50785

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    ABOUT THIS PAGE

    Clavulanic Acid Manufacturers

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

    Clavulanic Acid Suppliers

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

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

    Clavulanic Acid USDMF

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

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

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

    Clavulanic Acid KDMF

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

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

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

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

    Clavulanic Acid CEP

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

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

    Clavulanic Acid 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 Clavulanic Acid as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Clavulanic Acid GMP

    Clavulanic Acid 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 Clavulanic Acid 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 Clavulanic Acid GMP manufacturer or Clavulanic Acid GMP API supplier for your needs.

    Clavulanic Acid CoA

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

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

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