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Cefepime | CAS No: 88040-23-7 | GMP-certified suppliers
A medication that treats pneumonia, febrile neutropenia, and a broad range of complicated urinary, skin, and intra-abdominal infections caused by susceptible bacteria.
Therapeutic categories
AmidesAnti-Bacterial AgentsAnti-Infective AgentsAntibacterials for Systemic UseAntiinfectives for Systemic Usebeta-Lactams
Generic name
Cefepime
Molecule type
small molecule
CAS number
88040-23-7
DrugBank ID
DB01413
Approval status
Approved drug, Investigational drug
ATC code
J01DE01
Primary indications
- Cefepime is indicated for the treatment of pneumonia caused by susceptible bacteria, and for empiric therapy for febrile neutropenic patients
- Cefepime is also indicated for the treatment of uncomplicated and complicated urinary tract infections (cUTI) including pyelonephritis, uncomplicated skin and skin structure infections, and complicated intra-abdominal infections (used in combination with [metronidazole]) in adults caused by susceptible bacteria
- Cefepime is also used in combination with [enmetazobactam] to treat cUTI
Product Snapshot
- Cefepime is an injectable small‑molecule cephalosporin supplied mainly as intramuscular or intravenous powders for solution
- It is used for bacterial pneumonia, febrile neutropenia, cUTI including pyelonephritis, skin and skin structure infections, and intra‑abdominal infections, including use with metronidazole or enmetazobactam
- It is approved in the US and Canada, with additional investigational status in some contexts
Clinical Overview
Cefepime (CAS 88040-23-7) is a fourth‑generation cephalosporin used globally for severe bacterial infections requiring broad Gram‑positive and Gram‑negative coverage. It is indicated for hospital‑acquired and community‑acquired pneumonia caused by susceptible organisms and is commonly employed as empiric therapy in febrile neutropenia. Additional indications include uncomplicated and complicated urinary tract infections, pyelonephritis, uncomplicated skin and skin structure infections, and complicated intra‑abdominal infections when combined with metronidazole. Cefepime is also used with enmetazobactam in the treatment of complicated urinary tract infections.
Cefepime exhibits extended activity against Enterobacteriaceae, Pseudomonas aeruginosa, and methicillin‑susceptible Staphylococcus aureus. Its pharmacodynamic profile reflects strong stability to chromosomal and plasmid‑mediated beta‑lactamases and low induction of type 1 beta‑lactamases. Bactericidal activity results from binding to penicillin‑binding proteins, inhibiting late‑stage peptidoglycan synthesis. Key binding targets include PBP‑3 and PBP‑1 in Escherichia coli and Pseudomonas aeruginosa and PBP‑2 in E. coli and Enterobacter cloacae. Efficacy correlates with the time that unbound plasma concentrations exceed the MIC of the infecting organism.
Cefepime is administered parenterally and demonstrates good tissue penetration; inflamed meningeal tissues may enhance central nervous system exposure. Renal elimination predominates, and dose adjustments are required in renal impairment to mitigate toxicity. Neurotoxicity, including encephalopathy and seizures, has been reported, particularly in patients with decreased renal function, and is linked to both blood‑brain barrier penetration and GABA inhibition. The compound is generally well tolerated aside from these predictable beta‑lactam–associated adverse effects.
Notable usage contexts include treatment of multidrug‑resistant nosocomial infections and settings where stability to beta‑lactamases is critical.
For API procurement, manufacturers should verify compliance with compendial quality standards, demonstrate control of impurity profiles, and ensure robust sterile handling and packaging suitable for parenteral formulation development.
Cefepime exhibits extended activity against Enterobacteriaceae, Pseudomonas aeruginosa, and methicillin‑susceptible Staphylococcus aureus. Its pharmacodynamic profile reflects strong stability to chromosomal and plasmid‑mediated beta‑lactamases and low induction of type 1 beta‑lactamases. Bactericidal activity results from binding to penicillin‑binding proteins, inhibiting late‑stage peptidoglycan synthesis. Key binding targets include PBP‑3 and PBP‑1 in Escherichia coli and Pseudomonas aeruginosa and PBP‑2 in E. coli and Enterobacter cloacae. Efficacy correlates with the time that unbound plasma concentrations exceed the MIC of the infecting organism.
Cefepime is administered parenterally and demonstrates good tissue penetration; inflamed meningeal tissues may enhance central nervous system exposure. Renal elimination predominates, and dose adjustments are required in renal impairment to mitigate toxicity. Neurotoxicity, including encephalopathy and seizures, has been reported, particularly in patients with decreased renal function, and is linked to both blood‑brain barrier penetration and GABA inhibition. The compound is generally well tolerated aside from these predictable beta‑lactam–associated adverse effects.
Notable usage contexts include treatment of multidrug‑resistant nosocomial infections and settings where stability to beta‑lactamases is critical.
For API procurement, manufacturers should verify compliance with compendial quality standards, demonstrate control of impurity profiles, and ensure robust sterile handling and packaging suitable for parenteral formulation development.
Identification & chemistry
| Generic name | Cefepime |
|---|---|
| Molecule type | Small molecule |
| CAS | 88040-23-7 |
| UNII | 807PW4VQE3 |
| DrugBank ID | DB01413 |
Pharmacology
| Summary | Cefepime is a fourth‑generation cephalosporin that exerts bactericidal activity by binding and inhibiting penicillin‑binding proteins involved in the final steps of peptidoglycan synthesis. Its pharmacology is characterized by broad Gram‑positive and Gram‑negative activity, including stability against many beta‑lactamases and affinity for key PBPs in Enterobacterales and Pseudomonas aeruginosa. Time above the organism’s MIC drives its antimicrobial effect, and CNS penetration with GABA inhibition is associated with observed neurotoxic effects. |
|---|---|
| Mechanism of action | Cefepime is a bactericidal cephalosporin with a mode of action similar to other beta-lactam antibiotics.Cefepime disrupts bacterial cell walls by binding and inhibiting transpeptidases known as penicillin-binding proteins (PBPs), which are enzymes involved in the final stages of peptidoglycan layer synthesis. This results in the lysis and death of susceptible microorganisms.Cefepime has a broad spectrum of _in vitro_ activity that includes both Gram-positive and Gram-negative bacteria.Cefepime has affinity for PBP-3 and PBP-1 in _Escherichia coli_ and _Pseudomonas aeruginosa_, as well as PBP-2 in _E. coli_ and _Enterobacter cloacae_. |
| Pharmacodynamics | Cefepime is a fourth-generation cephalosporin antibiotic.It is active against Gram-negative bacteria such as _Enterobacter_ spp., _Escherichia coli_, _Klebsiella pneumoniae_, _Proteus mirabilis_ and _Pseudomonas aeruginosa_, and Gram-positive bacteria such as _Staphylococcus aureus_ (methicillin-susceptible isolates only), _Streptococcus pneumoniae_, _Streptococcus pyogenes_ and Viridans group streptococci.Compared to third-generation cephalosporins, cefepime has an extended Gram-negative coverage. Whereas other cephalosporins are degraded by plasmid- and chromosome-mediated beta-lactamases, cefepime is stable and not significantly hydrolyzed by these enzymes.Cefepime is also a poor inducer of type 1 beta-lactamases and, therefore, a good alternative against bacteria resistant to third-generation cephalosporins. In animal models of infection, the time that the unbound plasma concentration of cefepime exceeds the minimum inhibitory concentration (MIC) of infecting organisms has been shown to correlate with treatment efficacy.It has been suggested that cefepime can cross the inflamed blood-brain barrier.This, along with its ability to inhibit γ-aminobutyric acid (GABA), could lead to the neurotoxic effects observed in some of the patients treated with cefepime. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 1A | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 1B | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 2 | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Healthy adult male volunteers (n=9) given a single intravenous infusion of 500 mg, 1 g, and 2 g of cefepime had a corresponding C<sub>max</sub> of 39.1, 81.7 and 163.9 μg/mL, and a corresponding AUC of 70.8, 148.5 and 284.8 h⋅μg/mL.On the other hand, healthy adult male volunteers given a single intramuscular infusion of 500 mg, 1 g, and 2 g of cefepime had a corresponding C<sub>max</sub> of 13.9, 29.6 and 57.5 μg/mL, a corresponding AUC of 60, 137 and 262 h⋅μg/mL, and a corresponding T<sub>max</sub> of 1.4, 1.6 and 1.5 h. A study in healthy adult male volunteers (n=7) that received clinically relevant doses for 9 days suggests that cefepime is not accumulated in the body. Between 250 mg and 2 g, cefepime follows a linear pharmacokinetic model, and the absolute bioavailability of cefepime in pediatric patients (n=8) given an intramuscular dose of 50 mg/kg was 82.3%. |
|---|---|
| Half-life | Healthy adult male volunteers (n=9) given cefepime had an average half-life of 2 hours. In patients requiring hemodialysis, the average half-life was 13.5 hours, and in patients requiring continuous peritoneal dialysis, the average half-life was 19 hours. |
| Protein binding | The serum protein binding of cefepime is approximately 20%, independent of its concentration in serum. |
| Metabolism | Less than 1% of cefepime is metabolized in the liver.Cefepime is metabolized to N-methylpyrrolidine (NMP), which then undergoes rapid oxidation to form NMP-N-oxide, a more stable compound.NMP-N-oxide is the predominant metabolite of cefepime, while NMP and the 7-epimer of cefepime are minor byproducts.It has been suggested that flavin-containing mixed-function oxygenase mediates the oxidation of NMP to NMP-N-oxide. |
| Route of elimination | Cefepime is mainly eliminated by the kidneys, and most of it is excreted unchanged. Approximately 85% of cefepime administered to normal subjects is excreted unchanged in urine. Less than 1% of the administered dose is recovered from urine as N-methylpyrrolidine (NMP), 6.8% as NMP-N-oxide, and 2.5% as an epimer.Dosage adjustments are required in patients with renal dysfunction or those undergoing hemodialysis, due to the importance of renal excretion in eliminating cefepime. |
| Volume of distribution | The average steady-state volume of distribution of cefepime is 18.0 L. In pediatric patients, the average steady-state volume of distribution is 0.3 L/kg. |
| Clearance | Cefepime has a total body clearance of 120 mL/min in healthy volunteers, and in pediatric patients, the average total body clearance is 3.3 mL/min/kg.In geriatric patients (65 years of age and older) and patients with abnormal renal function, cefepime total body clearance decreases proportionally with creatinine clearance. |
Formulation & handling
- Cefepime is a small‑molecule β‑lactam formulated primarily as parenteral lyophilized powder, requiring reconstitution for IV or IM administration due to poor oral absorption and low lipophilicity.
- The molecule is highly hydrophilic (logP −4.2) and moderately water‑soluble, favoring aqueous solutions but requiring attention to pH and β‑lactam hydrolysis pathways during formulation and storage.
- Stability is influenced by temperature and diluent choice, with typical handling involving protection from prolonged room‑temperature exposure after reconstitution.
Regulatory status
| Lifecycle | The active ingredient is in a late‑stage lifecycle in the US and Canada, where key patents have expired or are nearing expiry. Both markets show characteristics of a mature segment with established generic participation or expected near‑term entry. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Cefepime’s manufacturing and supply landscape is dominated by multiple packagers, reflecting a mature, widely distributed product rather than reliance on a single originator company. Branded and non‑branded versions are established in the US and Canada, indicating broad regional availability. Patent expiry has led to long-standing generic competition, with numerous suppliers active in the market. |
|---|
Safety
| Toxicity | Patients who receive a cefepime overdose should be carefully observed and given supportive treatment. In case of renal insufficiency, peritoneal dialysis should not be performed.Instead, hemodialysis is recommended to aid in the removal of cefepime from the body. Some of the symptoms of a cefepime overdose are encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus._In vivo_ carcinogenicity studies for cefepime have not been performed. In chromosomal aberration studies, this antibiotic was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. Cefepime does not exhibit genotoxic effects in _in vitro_ assays, and _in vivo_ assessments of clastogenicity are negative. In rats given up to 1000 mg/kg/day (1.6 times the recommended maximum human dose), cefepime did not have negative effects on fertility. |
|---|
High Level Warnings:
- Overexposure is associated with neurotoxicity, including encephalopathy, myoclonus, seizures, and nonconvulsive status epilepticus
- In renal impairment, cefepime clearance is reduced
- Hemodialysis effectively enhances removal, while peritoneal dialysis is not effective
Cefepime is a type of Cephalosporins
Cephalosporins are a class of pharmaceutical active ingredients (APIs) widely used in the field of antibiotics. They belong to the beta-lactam family, which also includes penicillins. Cephalosporins are derived from a fungus called Acremonium cephalosporium and are known for their potent antimicrobial properties.
These APIs are commonly used to treat a wide range of bacterial infections, including respiratory tract infections, skin and soft tissue infections, urinary tract infections, and even meningitis. Cephalosporins work by inhibiting the synthesis of bacterial cell walls, leading to the disruption of bacterial growth and ultimately their destruction.
Cephalosporins are classified into generations based on their antimicrobial spectrum and activity against specific bacteria. The first-generation cephalosporins are effective against Gram-positive bacteria, while subsequent generations show broader activity against both Gram-positive and Gram-negative bacteria.
Pharmaceutical companies manufacture cephalosporins in various formulations, including tablets, capsules, injectable solutions, and suspensions. They are often prescribed by healthcare professionals and are available under different brand names in the market.
It is important to note that like other antibiotics, cephalosporins should be used judiciously to prevent the development of antibiotic resistance. Proper dosage and adherence to treatment guidelines are crucial to maximize their effectiveness and minimize the risk of resistance.
In conclusion, cephalosporins are a vital category of APIs widely used in the treatment of bacterial infections. Their broad spectrum of activity and effectiveness make them an essential tool in modern medicine.
Cefepime API manufacturers & distributors
Compare qualified Cefepime API suppliers worldwide. We currently have 14 companies offering Cefepime API, with manufacturing taking place in 8 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CoA, JDMF, USDMF | 36 products |
| Antibióticos do Brasila | Producer | Brazil | Brazil | CoA, JDMF | 3 products |
| API Corp. | Producer | Japan | Japan | CoA, JDMF | 11 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Corden Pharma | Producer | Germany | Germany | CoA, GMP, JDMF | 45 products |
| Kopran R.L. | Producer | India | India | CoA, GMP, WC | 8 products |
| NCPC Hebei Huamin | Producer | China | China | CoA, JDMF | 4 products |
| Qilu Antibiotics | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 33 products |
| Sandoz | Producer | Austria | Germany | CEP, CoA, FDA, GMP | 58 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shenzhen Salubris | Producer | China | China | CoA, JDMF, WC | 5 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 762 products |
| Sterile India | Producer | India | India | CoA, GMP, WC | 13 products |
When sending a request, specify which Cefepime API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Cefepime API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Cefepime API
Sourcing
What matters most when sourcing GMP-grade Cefepime?
Key considerations include confirming GMP compliance and ensuring the API meets relevant US and Canadian regulatory requirements. Assessing supplier qualification, including documentation and audit readiness, is essential given the mature, multi‑source supply landscape. It is also important to verify consistent quality and reliable availability across the various established packagers.
Which documents are typically required when sourcing Cefepime API?
Request the core API documentation set: CoA (14 companies), GMP (9 companies), JDMF (8 companies), USDMF (5 companies), WC (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Cefepime API?
Known or reported manufacturers for Cefepime: SETV Global, Sinoway industrial Co.,Ltd, Apollo Healthcare Resources (Singapore), AXXO GmbH. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Cefepime API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Cefepime manufacturers?
Audit reports may be requested for Cefepime: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Cefepime API on Pharmaoffer?
Reported supplier count for Cefepime: 14 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Cefepime API?
Production countries reported for Cefepime: China (4 producers), India (3 producers), Germany (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Cefepime usually hold?
Common certifications for Cefepime suppliers: CoA (14 companies), GMP (9 companies), JDMF (8 companies), USDMF (5 companies), WC (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Cefepime (CAS 88040-23-7) used for?
Cefepime is used to treat severe Gram‑positive and Gram‑negative bacterial infections, including hospital‑acquired and community‑acquired pneumonia. It is indicated for uncomplicated and complicated urinary tract infections, pyelonephritis, uncomplicated skin and skin structure infections, and complicated intra‑abdominal infections when combined with metronidazole. It is also employed as empiric therapy in febrile neutropenia and can be used with enmetazobactam for complicated urinary tract infections.
Which therapeutic class does Cefepime fall into?
Cefepime belongs to the following therapeutic categories: Amides, Anti-Bacterial Agents, Anti-Infective Agents, Antibacterials for Systemic Use, Antiinfectives for Systemic Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Cefepime mainly prescribed for?
The primary indications for Cefepime: Cefepime is indicated for the treatment of pneumonia caused by susceptible bacteria, and for empiric therapy for febrile neutropenic patients, Cefepime is also indicated for the treatment of uncomplicated and complicated urinary tract infections (cUTI) including pyelonephritis, uncomplicated skin and skin structure infections, and complicated intra-abdominal infections (used in combination with [metronidazole]) in adults caused by susceptible bacteria, Cefepime is also used in combination with [enmetazobactam] to treat cUTI. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Cefepime work?
Cefepime is a bactericidal cephalosporin with a mode of action similar to other beta-lactam antibiotics.Cefepime disrupts bacterial cell walls by binding and inhibiting transpeptidases known as penicillin-binding proteins (PBPs), which are enzymes involved in the final stages of peptidoglycan layer synthesis. This results in the lysis and death of susceptible microorganisms.Cefepime has a broad spectrum of _in vitro_ activity that includes both Gram-positive and Gram-negative bacteria.Cefepime has affinity for PBP-3 and PBP-1 in _Escherichia coli_ and _Pseudomonas aeruginosa_, as well as PBP-2 in _E. coli_ and _Enterobacter cloacae_.
What should someone know about the safety or toxicity profile of Cefepime?
Cefepime’s main safety concern is neurotoxicity, which may present as encephalopathy, myoclonus, seizures, or nonconvulsive status epilepticus, especially when drug exposure is elevated. Reduced renal function increases this risk because Cefepime clearance is diminished, so dose adjustment is required. Hemodialysis can enhance drug removal in cases of accumulation, whereas peritoneal dialysis is not effective. Aside from these effects, its tolerability aligns with predictable beta‑lactam adverse reactions.
What are important formulation and handling considerations for Cefepime as an API?
Cefepime is typically formulated as a lyophilized powder for parenteral use because its hydrophilicity and poor oral absorption favor reconstituted aqueous solutions. Formulation requires control of pH and avoidance of conditions that promote β‑lactam hydrolysis, as stability is sensitive to temperature and diluent choice. After reconstitution, solutions should be protected from prolonged room‑temperature exposure. Handling practices should maintain aseptic technique and minimize time in solution to limit degradation.
Is Cefepime a small molecule?
Cefepime is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Cefepime?
Cefepime is not formulated for oral administration because of its poor oral absorption and high hydrophilicity, so specific oral stability considerations do not apply. Its known stability issues relate to β‑lactam hydrolysis, which is influenced by pH, temperature, and time in aqueous solution. For the parenteral product, protection from prolonged room‑temperature exposure after reconstitution is important.
Regulatory
Where is Cefepime approved or in use globally?
Cefepime is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Cefepime right now?
Cefepime is regulated for use in both Canada and the United States under their respective national health authority frameworks. Patent status is managed within each jurisdiction’s standard pharmaceutical patent system without additional specifics noted in the current context.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Cefepime procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Cefepime. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Cefepime included in the PRO Data Insights coverage?
PRO Data Insights coverage for Cefepime: 1733 verified transactions across 457 suppliers and 227 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Cefepime?
Market report availability for Cefepime: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
