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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.)

    API Reference Price

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HK Hong Kong, , HONG KONG HONG KONG","customerAddress":"414,SHRIKANT CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734373800,"product":"POTASSIUM CLAVULANATE DILUTED (POTASSIUM CLAVULANATE WITH MI CROCRYSTALLINE CELLULOSE)(1:1) I.P.(221 DRM)( CREDIT PHARMA","address":"302-CEEJAY HOUSE, SHIV SAGAR ESTATE, DR.ANNIE BESANT ROAD","city":"MUMBAI","supplier":"N\/A","supplierCountry":"CHINA","foreign_port":"XINGANG","customer":"ARSHIYA PANVEL LOGISTICS SERVICES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"4420.00","actualQuantity":"4420","unit":"KGS","unitRateFc":"78","totalValueFC":"347523.2","currency":"USD","unitRateINR":"6680.7","date":"17-Dec-2024","totalValueINR":"29528694","totalValueInUsd":"347523.2","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29419090","bill_no":"7284579","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"XINGANG","supplierAddress":"N\/A","customerAddress":"302-CEEJAY HOUSE, SHIV SAGAR ESTATE, DR.ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734373800,"product":"POTASSIUM CLAVULANATE DILUTED (POTASSIUM CLAVULANATE WITH SI LICON DIOXIDE)(1:1) I.P.(221 DRM)( CREDIT PHARMA CO LTD)IUP","address":"302-CEEJAY HOUSE, SHIV SAGAR ESTATE, DR.ANNIE BESANT ROAD","city":"MUMBAI","supplier":"N\/A","supplierCountry":"CHINA","foreign_port":"XINGANG","customer":"ARSHIYA PANVEL LOGISTICS SERVICES PRIVATE 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SERVICES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"11550.00","actualQuantity":"11550","unit":"KGS","unitRateFc":"77.1","totalValueFC":"897133.2","currency":"USD","unitRateINR":"6599.9","date":"17-Dec-2024","totalValueINR":"76228500","totalValueInUsd":"897133.2","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29419090","bill_no":"7285870","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"XINGANG","supplierAddress":"N\/A","customerAddress":"302-CEEJAY HOUSE, SHIV SAGAR ESTATE, DR.ANNIE BESANT 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":"7, VASANT MARG IIND FLOOR","city":"NEW DELHI","supplier":"JOINT FORCE PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"KUNMING","customer":"COPMED PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"3003.00","actualQuantity":"3003","unit":"KGS","unitRateFc":"84.4","totalValueFC":"256426.8","currency":"USD","unitRateINR":"7255.5","date":"23-Dec-2024","totalValueINR":"21788324.89","totalValueInUsd":"256426.8","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"7404314","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"KUNMING","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":"7, VASANT MARG IIND FLOOR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"DILUTED CLAVULANATE POTASSIUM(1:1)AVICEL BP\/USP(POTASSIUM CLAVU DILUTED IP(POTASSIUM CLAVULA WITH MICROCRY CELLUL(1:1)IPPOTASSIUM CLAVULANATE DILUTED BP 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","customerCountry":"INDIA","quantity":"4380.00","actualQuantity":"4380","unit":"KGS","unitRateFc":"81.3","totalValueFC":"359983.8","currency":"USD","unitRateINR":"6983.4","date":"27-Dec-2024","totalValueINR":"30587456.25","totalValueInUsd":"359983.8","indian_port":"JNPT","hs_no":"29419090","bill_no":"7486856","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"XINGANG (CHINA)","supplierAddress":"6 FUK WANG STREET YUEN LONG INDUSTR IAL ESTATE, YUEN LONG HONG KONG , , China","customerAddress":"PLOT NO.16,VARDHMAN INDUSTRIAL"},{"dataSource":"API 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 Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735497000,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHSILICON DIOXIDE)(1:1) I.PPOTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITH","address":"BEETAL HOUSE, 99, MADANGIR","city":"NEW DELHI","supplier":"JOINT FORCE PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"GUIYANG","customer":"DEL TRADE INTERNATIONAL ","customerCountry":"INDIA","quantity":"5.01","actualQuantity":"5.01","unit":"KGS","unitRateFc":"88.7","totalValueFC":"449.7","currency":"USD","unitRateINR":"7627.6","date":"30-Dec-2024","totalValueINR":"38214.26","totalValueInUsd":"449.7","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"7526074","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Diluted","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":"BEETAL HOUSE, 99, MADANGIR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735497000,"product":"POTASSIUM CLAVULANATE DILUTED (POTASSIUM CLAVULANATE WITH MI CROCRYSTALLINE CELLULOSE)(1:1) I.P.(162 DRM)( CREDIT PHARMA","address":"302-CEEJAY HOUSE, SHIV SAGAR ESTATE, 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    01-Jan-2021
    30-Dec-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

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    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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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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    Potassium Clavulanate Manufacturers

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

    Potassium Clavulanate Suppliers

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

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

    Potassium Clavulanate USDMF

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

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

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

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

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

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

    Potassium Clavulanate CEP

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

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

    Potassium 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 Potassium Clavulanate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Potassium Clavulanate GMP

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

    Potassium Clavulanate CoA

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

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

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