menu
    • menu

    Find Cefuroxime Axetil manufacturers, exporters & distributors on PharmaCompass

    NEW Prospects: 3
    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    Virtual Booth

    Contact Supplier

    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

    Virtual Booth

    Contact Supplier

    Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

    Virtual Booth

    Contact Supplier

    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

    Virtual Booth

    Contact Supplier

    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

    Virtual Booth

    Contact Supplier

    pharmacompass-2-m-2026-03-23

    Virtual Booth

    Contact Supplier

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    REF. STANDARDS & IMPURITIES

    ANALYTICAL

    PharmaCompass

    Synopsis

    Related ProductsRelated Products

    Synopsis

    ACTIVE PHARMA INGREDIENTS

    69

    API Suppliers

    38

    USDMF

    20

    CEP/COS

    1

    JDMF

    8

    EU WC

    22

    KDMF

    4

    NDC API

    0

    VMF

    18

    Listed Suppliers

    0INTERMEDIATES

    REF. STANDARDS OR IMPURITIES

    1

    EDQM

    1

    USP

    0

    JP

    7

    Others

    FINISHED DOSAGE FORMULATIONS

    361

    FDF Dossiers

    34

    FDA Orange Book

    217

    Europe

    7

    Canada

    0

    Australia

    9

    South Africa

    94

    Listed Dossiers

    3PROSPECTS

    4DRUGS IN DEVELOPMENT

    FDF DossiersDRUG PRODUCT COMPOSITIONS

    264RELATED EXCIPIENT COMPANIES

    453EXCIPIENTS BY APPLICATIONS

    PATENTS & EXCLUSIVITIES

    0

    US Patents

    0

    US Exclusivities

    2

    Health Canada Patents

    GLOBAL SALES INFORMATION

    US Medicaid

    20,650,959

    Annual Reports

    NA

    Regulatory FDF Prices

    MARKET PLACE

    26

    API

    30

    FDF

    DIGITAL CONTENT

    0

    Data Compilation #PharmaFlow

    0

    Stock Recap #PipelineProspector

    0

    Weekly News Recap #Phispers

    14

    News #PharmaBuzz

    Chemistry

    Click the arrow to open the dropdown
    read-moreClick the button for full data set
    read-moreClick the button for full data set
    Also known as: 97232-96-7, Cefuroxime axetil, (e)-, 64544-07-6, (+/-)-cefuroxime axetil, (e)-, Xsl6i3sb26, Ceftin
    Molecular Formula
    C20H22N4O10S
    Molecular Weight
    510.5  g/mol
    InChI Key
    KEJCWVGMRLCZQQ-DJMWJSSGSA-N
    FDA UNII
    XSL6I3SB26
    Cefuroxime Axetil
    Cefuroxime Axetil is a second generation semi-synthetic cephalosporin and a beta-lactam antibiotic with bactericidal activity. Cefuroxime's effect is dependent on its binding to penicillin-binding proteins (PBPs) located in the bacterial cytoplasmic membrane. Binding results in the inhibition of the transpeptidase enzymes, thereby preventing cross-linking of the pentaglycine bridge with the fourth residue of the pentapeptide and interrupting consequent synthesis of peptidoglycan chains. As a result, cefuroxime inhibits bacterial septum and cell wall synthesis formation.
    1 2D Structure

    Cefuroxime Axetil

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-acetyloxyethyl (6R,7R)-3-(carbamoyloxymethyl)-7-[[(2E)-2-(furan-2-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
    2.1.2 InChI
    InChI=1S/C20H22N4O10S/c1-9(25)33-10(2)34-19(28)15-11(7-32-20(21)29)8-35-18-14(17(27)24(15)18)22-16(26)13(23-30-3)12-5-4-6-31-12/h4-6,10,14,18H,7-8H2,1-3H3,(H2,21,29)(H,22,26)/b23-13+/t10?,14-,18-/m1/s1
    2.1.3 InChI Key
    KEJCWVGMRLCZQQ-DJMWJSSGSA-N
    2.1.4 Canonical SMILES
    CC(OC(=O)C)OC(=O)C1=C(CSC2N1C(=O)C2NC(=O)C(=NOC)C3=CC=CO3)COC(=O)N
    2.1.5 Isomeric SMILES
    CC(OC(=O)C)OC(=O)C1=C(CS[C@H]2N1C(=O)[C@H]2NC(=O)/C(=N/OC)/C3=CC=CO3)COC(=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    XSL6I3SB26
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acetoxyethylcefuroxime

    2. Cci 15641

    3. Cci-15641

    4. Ceftin

    5. Cefurax

    6. Cefuroxime 1-acetoxyethyl Ester

    7. Cepazine

    8. Cetoxil

    9. Curocef

    10. Elobact

    11. Novador

    12. Novocef

    13. Oraxim

    14. Zinat

    15. Zinnat

    2.3.2 Depositor-Supplied Synonyms

    1. 97232-96-7

    2. Cefuroxime Axetil, (e)-

    3. 64544-07-6

    4. (+/-)-cefuroxime Axetil, (e)-

    5. Xsl6i3sb26

    6. Ceftin

    7. Cefuroxime Axetil E-isomers

    8. 1-acetyloxyethyl (6r,7r)-3-(carbamoyloxymethyl)-7-[[(2e)-2-(furan-2-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

    9. (1rs)-1-(acetyloxy)ethyl (6r,7r)-3-((carbamoyloxy)methyl)-7-(((e)-2-(furan-2-yl)-2-(methoxyimino)acetyl)amino)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2carboxylate

    10. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-(((2e)-2-(2-furanyl)-2-(methoxyimino)acetyl)amino)-8-oxo-, 1-(acetyloxy)ethyl Ester, (6r,7r)-

    11. Unii-xsl6i3sb26

    12. Cefuroxime Axetil Impurity B [ep]

    13. Cefuroximeaxetil

    14. Cefuroxime Axetil Specified Impurity B [ep]

    15. Schembl41099

    16. Schembl379336

    17. Dtxsid20242788

    18. Mfcd00864991

    19. Akos037643328

    20. Ncgc00185751-06

    21. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-((2-furanyl(methoxyimino)acetyl)amino)-8-oxo-, 1-(acetyloxy)ethyl Ester, (6r-(6alpha,7beta(e)))-

    22. Cefuroxime Axetil E-isomers [usp-rs]

    23. Cefuroxime Axetil Impurity B [ep Impurity]

    24. Q3604308

    25. 1-(acetyloxy)ethyl (6r,7r)-3-{[(aminocarbonyl)oxy]methyl}-7-({(2e)-2-furan-2-yl-2-[(methyloxy)imino]acetyl}amino)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

    26. 1-acetoxyethyl (6r,7r)-3-carbamoyloxymethyl-7-[(z)-2-(fur-2-yl)-2-methoxyiminoacetamido]ceph-3-em-4-carboxylate

    27. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-((2-furanyl(methoxyimino)acetyl)amino)-8-oxo-, 1-(acetyloxy)ethyl Ester, (6r-(6.alpha.,7.beta.(e)))-

    28. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 3-[[(aminocarbonyl)oxy]methyl]-7-[[(2z)-2-(2-furanyl)-2-(methoxyimino)acetyl]amino]-8-oxo-, 1- (acetyloxy)ethyl Ester, (6r,7r)-

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 510.5 g/mol
    Molecular Formula C20H22N4O10S
    XLogP30.9
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count12
    Exact Mass510.10566408 g/mol
    Monoisotopic Mass510.10566408 g/mol
    Topological Polar Surface Area214 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity968
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameCefuroxime axetil
    Drug LabelCefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, i...
    Active IngredientCefuroxime axetil
    Dosage FormTablet; For suspension
    RouteOral
    Strengtheq 250mg base/5ml; eq 500mg base; eq 125mg base; eq 250mg base; eq 125mg base/5ml
    Market StatusPrescription
    CompanyWockhardt; Ranbaxy; Teva; Apotex; Alkem Labs; Aurobindo Pharma; Lupin; Orchid Hlthcare

    2 of 2  
    Drug NameCefuroxime axetil
    Drug LabelCefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, i...
    Active IngredientCefuroxime axetil
    Dosage FormTablet; For suspension
    RouteOral
    Strengtheq 250mg base/5ml; eq 500mg base; eq 125mg base; eq 250mg base; eq 125mg base/5ml
    Market StatusPrescription
    CompanyWockhardt; Ranbaxy; Teva; Apotex; Alkem Labs; Aurobindo Pharma; Lupin; Orchid Hlthcare

    4.2 Therapeutic Uses

    Anti-Bacterial Agent

    National Library of Medicine's Medical Subject Headings. Cefuroxime axetil. Online file (MeSH, 2014). Available from, as of November 19, 2013: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Ceftin tablets and oral suspension /are indicated for/ acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilusinfluenzae(including beta-lactamase-producing strains), Moraxellacatarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4

    Ceftin tablets and oral suspension /are indicated for/ pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Ceftin Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4

    Ceftin tablets /are indicated for/ acute bacterial maxillary sinusitis caused by Streptococcus pneumoniaeorHaemophilusinfluenzae (non-beta-lactamase-producing strains only). NOTE: In view of the insufficient numbers of isolates of beta-lactamase-producing strains of Haemophilusinfluenzae and Moraxellacatarrhalis that were obtained from clinical trials with Ceftin Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of Ceftin Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase-producing Haemophilusinfluenzae or Moraxellacatarrhalis. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4

    For more Therapeutic Uses (Complete) data for Cefuroxime axetil (15 total), please visit the HSDB record page.

    4.3 Drug Warning

    Patients should be advised that antibacterials (including cefuroxime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold). Patients also should be advised about the importance of completing the full course of therapy, even if feeling better after a few days, and that skipping doses or not completing therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefuroxime or other antibacterials in the future.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 71

    To reduce development of drug-resistant bacteria and maintain effectiveness of cefuroxime and other antibacterials, the drug should be used only for the treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria. When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 71

    Prior to initiation of cefuroxime therapy, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cefuroxime axetil /is/ contraindicated in patients who are hypersensitive to cefuroxime or other cephalosporins and should be used with caution in patients with a history of hypersensitivity to penicillins. Use of cephalosporins should be avoided in patients who have had an immediate-type (anaphylactic) hypersensitivity reaction to penicillins.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 71

    Prescribing Ceftin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4

    For more Drug Warnings (Complete) data for Cefuroxime axetil (18 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]
    5.3 Absorption, Distribution and Excretion

    Following oral administration of cefuroxime axetil in pediatric patients with acute otitis media with effusion or with chronic or recurrent otitis media with effusion, cefuroxime is distributed into middle ear effusions. In a study in pediatric patients 1-4 years of age with acute otitis media with effusion who received a single 15 mg/kg dose of cefuroxime as cefuroxime axetil oral suspension, cefuroxime concentrations in middle ear effusions 2-5 hours after a dose ranged from 0.2-3.6 ug/mL; concurrent serum concentrations were 2.8-7.3 ug/mL.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74

    In pharmacokinetic studies of cefuroxime axetil oral suspension in children, the drug was administered postprandially or with food; no data are available regarding absorption of the suspension in fasting children. Following oral administration to children 3 months to 12 years of age (mean age: 23 months) of a single 10-, 15-, or 20-mg/kg dose of commercially available cefuroxime axetil oral suspension concomitantly with milk or milk products, peak serum cefuroxime concentrations are attained approximately 3.6, 2.7, or 3.1 hours after the dose, respectively, and average 3.3, 5.1, or 7 mcg/mL, respectively.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 73

    Results of a study in healthy adults indicate that cefuroxime axetil oral suspensions containing 125 mg/5 mL or 250 mg/5 mL are bioequivalent. In healthy adults who received a 250-mg dose of cefuroxime axetil given as a suspension containing 125 mg/5 mL or 250 mg/5 mL with food, peak plasma concentrations of cefuroxime were 2.4 or 2.2 aug/mL, respectively, and were attained 3 hours after the dose.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 73

    Following oral administration in adults of a single 125-mg, 250-mg, 500-mg, or 1-g dose of commercially available cefuroxime axetil tablets immediately following a meal, peak serum cefuroxime concentrations are attained approximately 2-3 hours after the dose and average 2.1, 4.1, 7, or 13.6 ug/mL, respectively; serum concentrations 6 hours after the dose average 0.3, 0.7, 2.2, or 3.4 ug/mL, respectively. AUC of the drug in these individuals averaged 6.7, 12.9, 27.4, or 50 mcg-h/mL, respectively.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 73

    For more Absorption, Distribution and Excretion (Complete) data for Cefuroxime axetil (13 total), please visit the HSDB record page.

    5.4 Metabolism/Metabolites

    Following oral administration, cefuroxime axetil is rapidly hydrolyzed to cefuroxime by nonspecific esterases in the intestinal mucosa and blood; the axetil moiety is metabolized to acetaldehyde and acetic acid. Cefuroxime is not metabolized and is excreted unchanged principally in urine by both glomerular filtration and tubular secretion.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74

    5.5 Biological Half-Life

    In neonates and children, the serum half-life of cefuroxime is inversely proportional to age.6 25 30 Following oral administration of cefuroxime axetil oral suspension in children 3 months to 12 years of age, the serum half-life of cefuroxime averages 1.4-1.9 hours.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74

    In adults, the serum or plasma half-life of cefuroxime following oral administration of commercially available cefuroxime axetil tablets or oral suspension ranges from 1.2-1.6 hours.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74

    Because cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. In a study of 20 elderly patients (mean age = 83.9 years) having a mean creatinine clearance of 34.9 mL/min, the mean serum elimination half-life was 3.5 hours.

    US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4

    5.6 Mechanism of Action

    Cefuroxime is usually bactericidal in action.Like other cephalosporins, the antibacterial activity of the drug results from inhibition of mucopeptide synthesis in the bacterial cell wall.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 72

    DRUG PRODUCT COMPOSITIONS

    Do you need Business Intel? Ask us

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

    USFDA APPLICATION NUMBER - 50605

    read-more

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

    USFDA APPLICATION NUMBER - 50605

    read-more

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

    USFDA APPLICATION NUMBER - 50605

    read-more

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

    USFDA APPLICATION NUMBER - 50672

    read-more

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

    USFDA APPLICATION NUMBER - 50672

    read-more

    Related Excipient Companies

    Upload your portfolio for free, ask us

    Excipients by Applications

    Click here to find the perfect excipient manufacturers by their capabilities

    Fillers, Diluents & Binders

    read-more
    read-more

    Coating Systems & Additives

    read-more
    read-more

    Direct Compression

    read-more
    read-more

    Thickeners and Stabilizers

    read-more
    read-more

    Lubricants & Glidants

    read-more
    read-more

    Controlled & Modified Release

    read-more
    read-more

    Solubilizers

    read-more
    read-more

    Taste Masking

    read-more
    read-more

    Chewable & Orodispersible Aids

    read-more
    read-more

    Disintegrants & Superdisintegrants

    read-more
    read-more

    Granulation

    read-more
    read-more

    Topical

    read-more
    read-more

    Parenteral

    read-more
    read-more

    Co-Processed Excipients

    read-more
    read-more

    Film Formers & Plasticizers

    read-more
    read-more

    Emulsifying Agents

    read-more
    read-more

    API Stability Enhancers

    read-more
    read-more

    Surfactant & Foaming Agents

    read-more
    read-more

    Rheology Modifiers

    read-more
    read-more

    Empty Capsules

    read-more
    read-more

    Vegetarian Capsules

    read-more
    read-more

    Coloring Agents

    read-more
    read-more

    Digital Content read-more

    Create Content with PharmaCompass, ask us

    NEWS #PharmaBuzz

    read-more
    read-more

    Global Sales Information

    Do you need Business Intel? Ask us

    Market Place

    Do you need sourcing support? Ask us

    Patents & EXCLUSIVITIES

    Check the patents & exclusivity for this product

    REF. STANDARDS & IMPURITIES

    Upload your portfolio for free, ask us

    USP

    read-more
    read-more

    ANALYTICAL

    Upload your methods for free, ask us

    ABOUT THIS PAGE

    Looking for 64544-07-6 / Cefuroxime Axetil API manufacturers, exporters & distributors?

    Cefuroxime Axetil manufacturers, exporters & distributors 1

    64

    PharmaCompass offers a list of Cefuroxime Axetil 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 Cefuroxime Axetil manufacturer or Cefuroxime Axetil supplier for your needs.

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

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

    API | Excipient name

    Cefuroxime Axetil

    Synonyms

    97232-96-7, Cefuroxime axetil, (e)-, 64544-07-6, (+/-)-cefuroxime axetil, (e)-, Xsl6i3sb26, Ceftin

    Cas Number

    64544-07-6

    Unique Ingredient Identifier (UNII)

    XSL6I3SB26

    About Cefuroxime Axetil

    Cefuroxime Axetil is a second generation semi-synthetic cephalosporin and a beta-lactam antibiotic with bactericidal activity. Cefuroxime's effect is dependent on its binding to penicillin-binding proteins (PBPs) located in the bacterial cytoplasmic membrane. Binding results in the inhibition of the transpeptidase enzymes, thereby preventing cross-linking of the pentaglycine bridge with the fourth residue of the pentapeptide and interrupting consequent synthesis of peptidoglycan chains. As a result, cefuroxime inhibits bacterial septum and cell wall synthesis formation.

    Zinnat Manufacturers

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

    Zinnat Suppliers

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

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

    Zinnat USDMF

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

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

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

    Zinnat JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Zinnat Drug Master File in Japan (Zinnat JDMF) empowers Zinnat API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Zinnat JDMF during the approval evaluation for pharmaceutical products. At the time of Zinnat JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Zinnat suppliers with JDMF on PharmaCompass.

    Zinnat KDMF

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

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

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

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

    Zinnat CEP

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

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

    Zinnat WC

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

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

    Zinnat 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 Zinnat as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Zinnat GMP

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

    Zinnat CoA

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

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

    Zinnat may be tested according to a variety of international standards, such as European Pharmacopoeia (Zinnat EP), Zinnat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zinnat 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.
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty
    • Privacy policy
    • Terms and conditions
    • Disclaimers
    • LinkedIn
    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search