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1. Axpim
2. Bmy 28142
3. Bmy-28142
4. Bmy28142
5. Cefepim
6. Cefepime Hydrochloride
7. Maxipime
8. Quadrocef
1. Maxipime
2. 88040-23-7
3. Cefepima
4. Cefepimum [latin]
5. Cefepima [spanish]
6. Cefepimum
7. Bmy-28142
8. Cfpm
9. Axepim
10. (6r,7r)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(1-methylpyrrolidin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
11. 807pw4vqe3
12. 1-(((6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-methylpyrrolidinium Hydroxide, Inner Salt, 7(sup 2)-(z)-(o-methyloxime)
13. Vnrx-5022
14. Chebi:478164
15. J01de01
16. Bmy 28142
17. (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
18. Cefepime (usan/inn)
19. Unii-807pw4vqe3
20. Cefepime [usan:inn:ban]
21. Cefepime, Antibiotic For Culture Media Use Only
22. Cefepime [usan]
23. Cefepime [inn]
24. Cefepime [mi]
25. Cefepime [vandf]
26. Cefepime [who-dd]
27. Chembl186
28. Schembl65720
29. Pyrrolidinium, 1-((7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-methyl-, Hydroxide, Inner Salt, (6r-(6alpha,7beta(z)))-
30. Dtxsid70873208
31. Bcpp000292
32. Hms2089m18
33. Hy-b0692
34. Bdbm50350470
35. Akos015850865
36. Akos016014147
37. Bcp9000504
38. Db01413
39. 7beta-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(1-methylpyrrolidinium-1-yl)methyl]-3,4-didehydrocepham-4-carboxylate
40. As-76125
41. Cs-0009590
42. C-2468
43. C08111
44. D02376
45. Ab01275446-01
46. Q27294816
47. 1-{[(6r,7r)-7-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}-1-methylpyrrolidin-1-ium
48. Pyrrolidinium, 1-((7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-methyl-, Hydroxide, Inner Salt, (6r-(6.alpha.,7.beta.(z)))-
| Molecular Weight | 480.6 g/mol |
|---|---|
| Molecular Formula | C19H24N6O5S2 |
| XLogP3 | -0.1 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 6 |
| Exact Mass | 480.12496023 g/mol |
| Monoisotopic Mass | 480.12496023 g/mol |
| Topological Polar Surface Area | 204 Ų |
| Heavy Atom Count | 32 |
| Formal Charge | 0 |
| Complexity | 869 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Maxipime |
| PubMed Health | Cefepime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | MAXIPIME (cefepime hydrochloride, USP) is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] o... |
| Active Ingredient | Cefepime hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Hospira |
| 2 of 2 | |
|---|---|
| Drug Name | Maxipime |
| PubMed Health | Cefepime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | MAXIPIME (cefepime hydrochloride, USP) is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] o... |
| Active Ingredient | Cefepime hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Hospira |
For the treatment of pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species. Also for empiric treatment of febrile neutropenic patients and uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms. Also for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes and complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
FDA Label
Cefepime is a fourth-generation cephalosporin antibiotic developed in 1994. Cefepime is active against Gram-positive and Gram-negative bacteria, with greater activity against both than third-generation antibiotics. Cefepime has good activity against important pathogens including Pseudomonas aeruginosa, Staphylococcus aureus, Enterobacteriaceae, and multiple drug resistant Streptococcus pneumoniae. Whereas other cephalosporins are degraded by many plasmid- and chromosome-mediated beta-lactamases, cefepime is stable and is a front line agent when infection with Enterobacteriaceae is known or suspected
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01D - Other beta-lactam antibacterials
J01DE - Fourth-generation cephalosporins
J01DE01 - Cefepime
Absorption
The absolute bioavailability of cefepime after an IM dose of 50 mg/kg was 82.3 (±15)% in eight patients.
Route of Elimination
Elimination of cefepime is principally via renal excretion with an average (SD) half-life of 2 (0.3) hours and total body clearance of 120 (8) mL/min in healthy volunteers. Cefepime is excreted in human milk.
Volume of Distribution
18.0 2.0 L
0.3 0.1 L/kg [Pediatric]
Clearance
120 mL/min [Healthy adult male receiving a single 30-minute IV infusions of cefepime]
3.3 +/-1.0 mL/min/kg [Petriatic patients (2 months 11 years of age) receiving a single IV dose]
Hepatic. Cefepime is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide).
2.0 (± 0.3) hours in normal patients. The average half-life in patients requiring hemodialysis was 13.5 (± 2.7) hours and in patients requiring continuous peritoneal dialysis was 19.0 (± 2.0) hours.
Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).
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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25913
Submission : 2012-05-05
Status : Active
Type : II
Certificate Number : R1-CEP 2012-242 - Rev 00
Issue Date : 2019-08-16
Type : Chemical
Substance Number : 2126
Status : Valid
Date of Issue : 2016-09-06
Valid Till : 2019-07-02
Written Confirmation Number : WC-0145
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-24
Pay. Date : 2013-06-14
DMF Number : 19806
Submission : 2006-09-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-15
Pay. Date : 2016-07-05
DMF Number : 24395
Submission : 2011-03-31
Status : Active
Type : II
Certificate Number : R0-CEP 2023-021 - Rev 00
Issue Date : 2023-07-27
Type : Chemical
Substance Number : 2126
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-17
Pay. Date : 2013-08-07
DMF Number : 25303
Submission : 2011-09-15
Status : Active
Type : II
Certificate Number : R1-CEP 2011-286 - Rev 01
Issue Date : 2021-12-21
Type : Chemical
Substance Number : 2126
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19755
Submission : 2006-09-07
Status : Inactive
Type : II
Certificate Number : R0-CEP 2007-134 - Rev 01
Issue Date : 2013-02-07
Type : Chemical
Substance Number : 2126
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21139
Submission : 2007-12-14
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-212 - Rev 01
Issue Date : 2018-02-23
Type : Chemical
Substance Number : 2126
Status : Withdrawn by Holder
Date of Issue : 2019-07-22
Valid Till : 2022-07-20
Written Confirmation Number : WC0131
Address of the Firm :
Certificate Number : R1-CEP 2007-205 - Rev 06
Issue Date : 2022-11-07
Type : Chemical
Substance Number : 2126
Status : Valid
Certificate Number : CEP 2008-081 - Rev 03
Issue Date : 2024-09-09
Type : Chemical
Substance Number : 2126
Status : Valid
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cefepime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefepime, including repackagers and relabelers. The FDA regulates Cefepime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefepime 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 Cefepime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefepime supplier is an individual or a company that provides Cefepime active pharmaceutical ingredient (API) or Cefepime finished formulations upon request. The Cefepime suppliers may include Cefepime API manufacturers, exporters, distributors and traders.
click here to find a list of Cefepime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefepime DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefepime active pharmaceutical ingredient (API) in detail. Different forms of Cefepime DMFs exist exist since differing nations have different regulations, such as Cefepime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefepime DMF submitted to regulatory agencies in the US is known as a USDMF. Cefepime USDMF includes data on Cefepime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefepime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefepime suppliers with USDMF on PharmaCompass.
A Cefepime CEP of the European Pharmacopoeia monograph is often referred to as a Cefepime Certificate of Suitability (COS). The purpose of a Cefepime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefepime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefepime to their clients by showing that a Cefepime CEP has been issued for it. The manufacturer submits a Cefepime CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefepime CEP holder for the record. Additionally, the data presented in the Cefepime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefepime DMF.
A Cefepime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefepime 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 Cefepime suppliers with CEP (COS) on PharmaCompass.
A Cefepime written confirmation (Cefepime WC) is an official document issued by a regulatory agency to a Cefepime manufacturer, verifying that the manufacturing facility of a Cefepime active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefepime APIs or Cefepime finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefepime WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefepime suppliers with Written Confirmation (WC) on PharmaCompass.
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 Cefepime as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefepime API and other APIs are published in this directory by the FDA.
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 Cefepime 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.
The NDC directory also contains data on finished compounded human drug products that contain Cefepime and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefepime NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefepime suppliers with NDC on PharmaCompass.
Cefepime 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 Cefepime 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 Cefepime GMP manufacturer or Cefepime GMP API supplier for your needs.
A Cefepime CoA (Certificate of Analysis) is a formal document that attests to Cefepime's compliance with Cefepime specifications and serves as a tool for batch-level quality control.
Cefepime CoA mostly includes findings from lab analyses of a specific batch. For each Cefepime 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.
Cefepime may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefepime EP), Cefepime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefepime USP).
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