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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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HSG. SOC.,","city":"MULUND (W) MUMBAI, MAHARASHTRA","supplier":"UNDISCLOSED","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON GATWAY PORT","customer":"DPB ANTIBIOTICS","customerCountry":"INDIA","quantity":"2100.00","actualQuantity":"2100","unit":"KGS","unitRateFc":"127","totalValueFC":"272052.9","currency":"USD","unitRateINR":"11131.6","date":"24-Jun-2025","totalValueINR":"23376255","totalValueInUsd":"272052.9","indian_port":"JNPT","hs_no":"29349990","bill_no":"2839023","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON GATWAY PORT","supplierAddress":"INVESTCAPITAL FARMA S L AVENNIDA DE LA TRANSICION ESPANOLA 24 PLANTA 1 EDIFICIO GAMMA ALCOBENDAS Madrid, SPAIN","customerAddress":"202\/C, SAI DHAM CO-OP. HSG. SOC.,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750703400,"product":"POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE (1:1) I.P.(1010 KGA)(101 DRM)(BOE NO: 2770335 DT 20.06.202POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOS","address":"305 AGGARWAL CITY SQUARE","city":"DELHI","supplier":"SHAH TC GLOBAL EXIM LLP","supplierCountry":"CHINA","foreign_port":"KUNMING","customer":"SHAH TC DISTRIBUTION LLP","customerCountry":"INDIA","quantity":"2382.59","actualQuantity":"2382.59","unit":"KGS","unitRateFc":"66.8","totalValueFC":"162370.8","currency":"USD","unitRateINR":"5855.7","date":"24-Jun-2025","totalValueINR":"13951776.3","totalValueInUsd":"162370.8","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29419090","bill_no":"2852357","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"KUNMING","supplierAddress":"UNIT NO. 142, 1ST FLOOR, ADMINISTRA TIVE BUILDING, , ARSHIYA FTWZ VILLA GE SAI TALUKA PANVEL,MAHARASHTRA, N INDIA","customerAddress":"305 AGGARWAL CITY SQUARE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750789800,"product":"POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1BULK DRUGS","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"ZHUHAI UNITED LABORATORIES TRADING","supplierCountry":"CHINA","foreign_port":"SHEKOU","customer":"MEDREICH LTD","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"75","totalValueFC":"114758","currency":"USD","unitRateINR":"6573.8","date":"25-Jun-2025","totalValueINR":"9860625","totalValueInUsd":"114758","indian_port":"Madras Sea","hs_no":"29411090","bill_no":"2864699","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"SHEKOU","supplierAddress":"COMPANY LIMITED, 7-8 FLOOR NEW OFFI CE OF ZHUHAI UNITED LABORATORIES NO 2428 ANJI ROAD SANZAO TOWN JINWAN CHINA","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750789800,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITH MICRO CRYSTALLINE CELLULOSE)(1:1) IP(AVICEL)(DTLS AS PERPOTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WI","address":"510-517, SHAH NAHAR INDL. ESTATE","city":"MUMBAI, MAHARASHTRA","supplier":"JOINT FORCE PHARMACEUTICAL LTD","supplierCountry":"CHINA","foreign_port":"EZHOU HUAHU","customer":"INDCHEMIE HEALTH SPECIALITIES PRIVATE LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"70","totalValueFC":"142809.9","currency":"USD","unitRateINR":"6135.5","date":"25-Jun-2025","totalValueINR":"12271000","totalValueInUsd":"142809.9","indian_port":"Calcutta Air","hs_no":"29420090","bill_no":"2865550","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"EZHOU HUAHU","supplierAddress":"RM. 1110A, TOWER A, HUNG HOM COMMER CIAL CENTER,39 MA TAU WAI ROAD,HUNG HOM,KOWLOON HK","customerAddress":"510-517, SHAH NAHAR INDL. ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750876200,"product":"DILUTED CLAVULANATE POTASSIUM (1:1) PH.EUR\/IP (POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE (1:1)DILUTED CLAVULANATE POTASSIUM (1:1) PH.EUR\/IP (POTASSIUM CLA","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"LONGCHEM INTERNATIONAL TRADING CO LTD","supplierCountry":"CHINA","foreign_port":"ZHENGZHOU","customer":"MICRO LABS LTD","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"73","totalValueFC":"372325.8","currency":"USD","unitRateINR":"6398.5","date":"26-Jun-2025","totalValueINR":"31992250","totalValueInUsd":"372325.8","indian_port":"Madras Air","hs_no":"29411090","bill_no":"2897216","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"ZHENGZHOU","supplierAddress":"UNIT 2 OF LG 1, MIRROR TOWER, 61 MODY ROAD, TSIM SHA TSUI, KOWLOON HONG KONG","customerAddress":"NO 31, RACE COURSE ROAD,BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750876200,"product":"POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE)(1:1) I.P.(10 KGA) (1 DRM) (BOE NO: 2185551 DT 21.05.2025)POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOS","address":"305 AGGARWAL CITY SQUARE","city":"DELHI","supplier":"SHAH TC GLOBAL EXIM LLP","supplierCountry":"CHINA","foreign_port":"KUNMING","customer":"SHAH TC DISTRIBUTION LLP","customerCountry":"INDIA","quantity":"23.59","actualQuantity":"23.59","unit":"KGS","unitRateFc":"69.9","totalValueFC":"1683.1","currency":"USD","unitRateINR":"6130.7","date":"26-Jun-2025","totalValueINR":"144622.5","totalValueInUsd":"1683.1","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29419090","bill_no":"2889030","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"KUNMING","supplierAddress":"UNIT NO. 142, 1ST FLOOR, ADMINISTRA TIVE BUILDING, , ARSHIYA FTWZ VILLA GE SAI TALUKA PANVEL,MAHARASHTRA, N INDIA","customerAddress":"305 AGGARWAL CITY SQUARE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE)(1:1) I.P.(1000 KGA) IUPAC NAME:POTASSIUM(2R,3Z,5R)-3-(2-HPOTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOS","address":"3RD FLOOR,MERCANTILE CHAMBERS","city":"MUMBAI,MAHARASHTRA","supplier":"SHAH TC GOLOBAL EXIM LLP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ARISTO PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"1769.25","actualQuantity":"1769.25","unit":"KGS","unitRateFc":"74.2","totalValueFC":"133884.3","currency":"USD","unitRateINR":"6502.2","date":"27-Jun-2025","totalValueINR":"11504062.46","totalValueInUsd":"133884.3","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29419090","bill_no":"2912434","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"SHANGHAI","supplierAddress":"FIRST FLOOR,UNIT NO.142,ACMINISTRAT IME BUILDING ,ARSHIYA FTWZ VILLAGE SAI,TALUKA PANVEL RAIGAD MAHARASHTR India","customerAddress":"3RD FLOOR,MERCANTILE CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"POTASSIUM CLAVULANATE DILUTED IP ( POTASSIUM CLAVULANATE WITH MICROCRYSTALLINE CELLULOSE (1:1)IPPOTASSIUM CLAVULANATE DILUTED IP ( POTASSIUM CLAVULANATE WIT","address":"BEETAL HOUSE, 99, MADANGIR","city":"NEW DELHI","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"DEL TRADE INTERNATIONAL PRIVATE LTD","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"62.5","totalValueFC":"191232.7","currency":"USD","unitRateINR":"5477.2","date":"27-Jun-2025","totalValueINR":"16431745.5","totalValueInUsd":"191232.7","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29419090","bill_no":"2907775","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"SHANGHAI PT","supplierAddress":"OFFICE F,32\/F,PLAZA 88,NO.88 YEUNG UK ROAD, TSUEN WAN NT, HONG KONG SDNF CHINA","customerAddress":"BEETAL HOUSE, 99, MADANGIR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1751049000,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHMICRO CRYSTALLINE CELLULOSE) (1:1) IP (2550 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Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1751221800,"product":"POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE (1:1) I.P.(21 DRM)(BOE NO:7000079 DT 14.05.2025) NAME:POTASSIUM(2R,3ZPOTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE (1:1) I.P","address":"SURVEY NO. 242\/243\/244, PLOT NO.1,","city":"JAMNAGAR-GUJARAT","supplier":"SHAH TC GLOBAL EXIM LLP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SPARSH BIO TECH PRIVATE LTD","customerCountry":"INDIA","quantity":"500.22","actualQuantity":"500.22","unit":"KGS","unitRateFc":"79.8","totalValueFC":"40700.8","currency":"USD","unitRateINR":"6991.4","date":"30-Jun-2025","totalValueINR":"3497234.98","totalValueInUsd":"40700.8","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29419090","bill_no":"2972283","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"UNIT NO. 142, 1ST FLOOR, ADMINISTRA TIVE 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    01-Jan-2022
    30-Jun-2025
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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

    Looking for 61177-45-5 / Clavulanic Acid API manufacturers, exporters & distributors?

    Clavulanic Acid manufacturers, exporters & distributors 1

    34

    PharmaCompass offers a list of Clavulanic Acid 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 Clavulanic Acid manufacturer or Clavulanic Acid supplier for your needs.

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

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

    API | Excipient name

    Clavulanic Acid

    Synonyms

    Potassium clavulanate, 61177-45-5, Clavulanic acid potassium salt, Brl 14151k, Clavulanate (potassium), Q42omw3at8

    Cas Number

    61177-45-5

    Unique Ingredient Identifier (UNII)

    Q42OMW3AT8

    About 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.

    Clavulanate Manufacturers

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

    Clavulanate Suppliers

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

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

    Clavulanate USDMF

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

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

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

    Clavulanate KDMF

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

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

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

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

    Clavulanate CEP

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

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

    Clavulanate 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 Clavulanate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Clavulanate GMP

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

    Clavulanate CoA

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

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

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