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Cefprozil | CAS No: 92665-29-7 | GMP-certified suppliers
A medication that treats respiratory, skin, soft tissue, urinary tract, and ENT bacterial infections caused by common pathogens including Streptococcus, Staphylococcus, Escherichia coli, and Klebsiella species.
Therapeutic categories
Primary indications
- For the treatment of the following infections (respiratory, skin, soft tissue, UTI, ENT) caused by
- S
- Pneumoniae, H
- Influenzae, staphylococci, S
Product Snapshot
- Cefprozil is an oral small molecule antibiotic available in various dosage forms including tablets, suspensions, and powders for suspension
- It is primarily indicated for the treatment of respiratory, skin, soft tissue, urinary tract, and ENT infections caused by specific bacterial strains such as S
- Pneumoniae, H
Clinical Overview
Pharmacologically, cefprozil functions by targeting bacterial cell wall synthesis. It is a beta-lactam antibiotic that binds to penicillin-binding proteins (PBPs) located within the bacterial cell wall. This binding inhibits the third and final stage of peptidoglycan cross-linking, compromising cell wall integrity. The bacterial cell subsequently undergoes lysis, facilitated through autolytic enzymes such as autolysins. There is also evidence suggesting cefprozil may interfere with autolysin inhibitors, enhancing bactericidal activity.
Key absorption, distribution, metabolism, and excretion (ADME) characteristics of cefprozil include oral bioavailability that allows for systemic use. The compound exhibits moderate protein binding and is primarily excreted unchanged via the renal route. Dose adjustments may be necessary in patients with renal impairment to prevent accumulation and toxicity.
Safety considerations include the potential for hypersensitivity reactions common to beta-lactam antibiotics and a risk of nephrotoxicity, particularly in vulnerable populations. Monitoring renal function is advisable when administering cefprozil, especially in patients with pre-existing renal disease.
Cefprozil is marketed under various brand names globally and is approved for systemic antibacterial use. From a sourcing and quality perspective, procurement of cefprozil API requires verification of chemical purity, compliance with pharmacopeial standards, and consideration of controlled storage to maintain stability. Suppliers should provide comprehensive analytical documentation and comply with relevant Good Manufacturing Practice (GMP) requirements to ensure consistent quality for pharmaceutical formulation.
Identification & chemistry
| Generic name | Cefprozil |
|---|---|
| Molecule type | Small molecule |
| CAS | 92665-29-7 |
| UNII | 1M698F4H4E |
| DrugBank ID | DB01150 |
Pharmacology
| Summary | Cefprozil is a second-generation cephalosporin antibiotic that targets penicillin-binding proteins (PBPs 1A, 2x, and 2B) to inhibit the final stage of bacterial cell wall synthesis. This inhibition disrupts cell wall integrity, leading to bacterial cell lysis mediated by autolytic enzymes. It is primarily used to treat infections caused by a range of Gram-positive and Gram-negative bacteria, including respiratory, skin, soft tissue, urinary tract, and ENT infections. |
|---|---|
| Mechanism of action | Cefprozil, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefprozil interferes with an autolysin inhibitor. |
| Pharmacodynamics | Cefprozil, a semisynthetic, second-generation cephalosporin, is used to treat otitis media, soft-tissue infections, and respiratory tract infections. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 1A | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | inhibitor |
| Penicillin-binding protein 2x | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | inhibitor |
| Penicillin-binding protein 2B | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | inhibitor |
ADME / PK
| Absorption | Oral bioavailability is approximately 95%. |
|---|---|
| Half-life | 1.3 hours |
| Protein binding | 36% |
| Metabolism | Cefprozil is eliminated primarily by the kidneys |
| Volume of distribution | * 0.23 L/kg |
| Clearance | * 3 mL/min/kg [fasting subjects] |
Formulation & handling
- Cefprozil is a small molecule cephalosporin antibiotic formulated exclusively for oral administration in tablet and suspension forms.
- The compound exhibits moderate aqueous solubility and no significant food interaction, allowing dosing without regard to meals.
- Formulations should consider the chemical stability of the beta-lactam ring typical of cephalosporins, ensuring appropriate storage and handling to prevent hydrolysis.
Regulatory status
| Lifecycle | The API's primary patents have expired, allowing generic entry in key markets including Canada and the US. As a result, the product is in a mature market phase with established availability across these regions. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Cefprozil's manufacturing and supply landscape includes multiple originator and generic companies involved primarily in packaging and distribution across the US and Canadian markets. The presence of branded products such as Apo-cefprozil and Auro-cefprozil indicates an established brand presence mainly in North America. Patent expiry has likely allowed for generic competition, as evidenced by the wide range of generic manufacturers active in the supply chain. |
|---|
Safety
| Toxicity | Single 5000 mg/kg oral doses of cefprozil caused no mortality or signs of toxicity in adult, weaning or neonatal rats, or adult mice. A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus monkeys, but no mortality. |
|---|
- High oral doses in rodent models produced no mortality or significant toxicity
- Oral administration at 3000 mg/kg in non-human primates induced transient gastrointestinal effects without mortality
- Handle with appropriate precautions to minimize exposure, considering potential for mild adverse biological responses at elevated doses
Cefprozil 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.
Cefprozil API manufacturers & distributors
Compare qualified Cefprozil API suppliers worldwide. We currently have 8 companies offering Cefprozil API, with manufacturing taking place in 3 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 |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC, WHO-GMP | 176 products |
| Covalent Labs. | Producer | India | India | CoA, USDMF | 5 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Parabolic Drugs | Producer | India | India | CoA, FDA, GMP, USDMF, WC | 11 products |
| Qilu Antibiotics | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 33 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
When sending a request, specify which Cefprozil 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 Cefprozil 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.
