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Ceftaroline fosamil | CAS No: 229016-73-3 | GMP-certified suppliers
A medication that treats acute bacterial skin infections and community-acquired pneumonia caused by susceptible pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
Therapeutic categories
Primary indications
- Ceftaroline fosamil is indicated for the treatment of patients with the following infections caused by susceptible isolates of the designated microorganisms
Product Snapshot
- Ceftaroline fosamil is formulated as a parenteral injectable powder for solution
- It is primarily used for the treatment of infections caused by susceptible bacterial isolates
- The product is approved for use in key regulatory markets including the US and EU
Clinical Overview
The drug’s mechanism of action involves inhibition of bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), including PBP2a of methicillin-resistant Staphylococcus aureus (MRSA), leading to bacterial cell death. This expanded binding profile distinguishes ceftaroline fosamil from earlier generation cephalosporins.
Pharmacodynamically, the efficacy of ceftaroline fosamil correlates with the time that unbound drug plasma concentrations exceed the minimum inhibitory concentration (MIC) of the targeted organisms, as demonstrated in neutropenic murine models using S. aureus and S. pneumoniae. Clinical safety data indicate no significant effects on the corrected QT interval (QTc) at therapeutic peak plasma concentrations.
Following parenteral administration, ceftaroline fosamil acts as a prodrug, undergoing rapid conversion to the active metabolite ceftaroline. Key pharmacokinetic parameters include renal excretion as the primary elimination pathway, emphasizing the need for dose adjustment in patients with renal impairment. Limited data indicate a standard half-life consistent with other cephalosporins.
Safety considerations note ceftaroline fosamil as a beta-lactam antibiotic with potential for hypersensitivity reactions in penicillin-allergic individuals. Nephrotoxicity risk factors should be monitored, particularly in populations with compromised renal function or concomitant nephrotoxic agents.
The API, registered under CAS number 229016-73-3, should be sourced with attention to compliance with pharmacopeial standards and regulatory requirements governing beta-lactam antibiotics. Consistency in purity, identity, and stability profiles is essential to pharmaceutical formulation and clinical outcomes.
Identification & chemistry
| Generic name | Ceftaroline fosamil |
|---|---|
| Molecule type | Small molecule |
| CAS | 229016-73-3 |
| UNII | 7P6FQA5D21 |
| DrugBank ID | DB06590 |
Pharmacology
| Summary | Ceftaroline fosamil is a bactericidal antibiotic targeting bacterial cell wall synthesis, effective against susceptible strains of Staphylococcus aureus and Streptococcus pneumoniae. Its pharmacodynamic activity correlates with the duration that unbound plasma concentrations exceed the minimum inhibitory concentration (MIC) of the pathogen. The drug does not significantly affect cardiac repolarization as measured by QTc interval. |
|---|---|
| Mechanism of action | Ceftaroline fosamil is an antibacterial drug. |
| Pharmacodynamics | The time that unbound plasma concentration of ceftaroline exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with S. aureus and S. pneumoniae. No significant effect on QTc (corrected QT interval) interval was detected at peak plasma concentration or at any other time. |
ADME / PK
| Half-life | 1.60 hours (600 mg dose). |
|---|---|
| Protein binding | approximately 20%. |
| Metabolism | Ceftaroline fosamil is converted into bioactive ceftaroline in plasma by a phosphatase enzyme. Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite ceftaroline M-1. |
| Route of elimination | primarily eliminated by the kidneys (6% in feces within 48 hours). |
| Volume of distribution | Median 20.3 L (18.3-21.6 L). |
Formulation & handling
- Ceftaroline fosamil is a small molecule cephalosporin antibiotic formulated primarily for intravenous use.
- Its low water solubility and negative LogP indicate the need for appropriate solubilization in formulation.
- Stability considerations include protection from moisture and maintaining conditions suitable for parenteral administration.
Regulatory status
| Lifecycle | The API is currently available in mature markets including the US and EU, with key patents expiring between December 2021 and February 2031. Market exclusivity is partially maintained until 2031, with some patents having expired, allowing for generic competition in certain regions. |
|---|
| Markets | US, EU |
|---|
Supply Chain
| Supply chain summary | Ceftaroline fosamil is marketed under multiple branded products, primarily in the US and EU markets, indicating a presence of originator companies with established supply networks. Patent protection extends in the US until at least 2030, suggesting that generic competition is currently limited but may increase after patent expiry dates in the early 2030s. This landscape supports continued branded manufacturing alongside potential future generic entrants. |
|---|
Safety
| Toxicity | LD50/LC50: Draize test, rabbit, eye: 100 mg/24H Moderate; Oral, mouse: LD50 = 300 mg/kg; Oral, rabbit: LD50 = 3200 mg/kg; Oral, rat: LD50 = 980 mg/kg. |
|---|
- Handle with appropriate personal protective equipment to avoid eye contact, as moderate irritation was observed in rabbit eye Draize tests at 100 mg/24H
- Toxicity profile indicates moderate acute oral toxicity in rodents (LD50 range: 300–3200 mg/kg)
- Avoid ingestion and ensure containment to prevent exposure
Ceftaroline fosamil 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.
Ceftaroline fosamil API manufacturers & distributors
Compare qualified Ceftaroline fosamil API suppliers worldwide. We currently have 2 companies offering Ceftaroline fosamil API, with manufacturing taking place in 2 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, USDMF | 36 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 762 products |
When sending a request, specify which Ceftaroline fosamil 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.).
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