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Chemistry

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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


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01-Jan-2022
30-Apr-2025
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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

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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

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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

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

USFDA APPLICATION NUMBER - 50672

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

USFDA APPLICATION NUMBER - 50672

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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.

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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.

Oraxim Manufacturers

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

Oraxim Suppliers

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

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

Oraxim USDMF

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

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

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

Oraxim KDMF

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

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

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

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

Oraxim CEP

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

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

Oraxim WC

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

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

Oraxim 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 Oraxim as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Oraxim GMP

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

Oraxim CoA

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

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

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