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Cefotaxime sodium sterile (Cefotaxime) API Manufacturers & Suppliers
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Cefotaxime | CAS No: 63527-52-6 | GMP-certified suppliers
A medication that treats serious bacterial infections including gonorrhoea, meningitis, and urinary tract infections, while also preventing postoperative infections.
Therapeutic categories
Primary indications
- Used to treat gonorrhoea, meningitis, and severe infections including infections of the kidney (pyelonephritis) and urinary system
- Also used before an operation to prevent infection after surgery
Product Snapshot
- Cefotaxime is available as an injectable small molecule antibiotic in solution and powder forms for parenteral administration
- It is primarily indicated for treatment of severe infections including meningitis, gonorrhoea, urinary system infections, and surgical infection prophylaxis
- Cefotaxime is approved for use in key regulatory markets including the US and Canada
Clinical Overview
Pharmacodynamically, cefotaxime exhibits broad-spectrum antibacterial activity against both Gram-positive and Gram-negative organisms, although it lacks efficacy against Pseudomonas aeruginosa. Its mechanism of action involves bactericidal inhibition of bacterial cell wall synthesis by binding with high affinity to penicillin-binding proteins (PBPs), particularly PBP Ib and PBP III. This action disrupts the cross-linking of peptidoglycan chains essential for cell wall structural integrity. Notably, cefotaxime demonstrates resistance to penicillinases which enables it to be effective against penicillin-resistant bacterial strains.
Key pharmacokinetic properties include intravenous administration, with cefotaxime sodium available commercially under various brand names such as Claforan (Sanofi-Aventis). The drug is partially metabolized in the liver to an active desacetyl metabolite and is eliminated primarily via renal excretion. Its elimination half-life ranges between one and one and a half hours in patients with normal renal function.
Safety considerations include potential nephrotoxicity and a possible reduction in seizure threshold, warranting caution in patients with renal impairment or predisposing neurological conditions. Allergic reactions consistent with beta-lactam hypersensitivity may occur, requiring appropriate screening and monitoring.
From an API procurement and quality perspective, cefotaxime must conform to stringent purity and stability standards due to its beta-lactam structure, which is susceptible to hydrolysis. Sourcing from manufacturers compliant with current Good Manufacturing Practices (cGMP) and with comprehensive analytical characterization is essential for maintaining consistent therapeutic efficacy and safety in pharmaceutical formulations.
Identification & chemistry
| Generic name | Cefotaxime |
|---|---|
| Molecule type | Small molecule |
| CAS | 63527-52-6 |
| UNII | N2GI8B1GK7 |
| DrugBank ID | DB00493 |
Pharmacology
| Summary | Cefotaxime is a third-generation cephalosporin antibiotic with broad-spectrum bactericidal activity against Gram-positive and Gram-negative bacteria, excluding Pseudomonas aeruginosa. Its mechanism of action involves inhibition of bacterial cell wall synthesis through high-affinity binding to multiple penicillin-binding proteins, including PBP 1b and PBP III. Cefotaxime is resistant to penicillinase degradation, enhancing its efficacy against penicillin-resistant bacterial strains. |
|---|---|
| Mechanism of action | The bactericidal activity of cefotaxime results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Cefotaxime shows high affinity for penicillin-binding proteins in the cell wall including PBP Ib and PBP III. |
| Pharmacodynamics | Cefotaxime is a third generation intravenous cephalosporin antibiotic. It has broad spectrum activity against Gram positive and Gram negative bacteria. It does not have activity against <i>Pseudomonas aeruginosa</i>. Cefotaxime works by inhibiting bacterial cell wall biosynthesis. A positive feature of cefotaxime is that it display a resistance to penicillinases and is useful to treat infections that are resistant to penicillin derivatives. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 1b | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
| Penicillin-binding protein 2a | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
| Penicillin-binding protein 3 | Bacillus subtilis (strain 168) | inhibitor |
ADME / PK
| Absorption | Rapidly absorbed following intramuscular injection. |
|---|---|
| Half-life | Approximately 1 hour. |
| Metabolism | Approximately 20-36% of an intravenously administered dose of 14C-cefotaxime is excreted by the kidney as unchanged cefotaxime and 15-25% as the desacetyl derivative, the major metabolite. The desacetyl metabolite has been shown to contribute to the bactericidal activity. Two other urinary metabolites (M2 and M3) account for about 20-25%. They lack bactericidal activity. |
| Route of elimination | Approximately 20-36% of an intravenously administered dose of 14C-cefotaxime is excreted by the kidney as unchanged cefotaxime and 15-25% as the desacetyl derivative, the major metabolite. |
Formulation & handling
- Cefotaxime is a small molecule cephalosporin antibiotic formulated primarily for parenteral administration via intravenous or intramuscular injection.
- The API is supplied as a solid powder for reconstitution to solution, requiring aseptic techniques and consideration of stability post-reconstitution.
- Due to low water solubility and ester functionality, proper pH and solvent conditions are critical to maintain stability during handling and formulation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is approaching patent expiry in the US and Canada, marking a transition toward generic entry and increased market competition. As a result, the product is entering a mature phase with expanded availability across both markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Cefotaxime is supplied by multiple manufacturers and packagers, indicating a diversified production landscape. Branded cefotaxime products have a presence primarily in the US and Canadian markets. Patent expiration has enabled generic competition, reflected by the involvement of numerous generic pharmaceutical companies alongside originator entities. |
|---|
Safety
| Toxicity | Adverse effects following overdosage include nausea, vomiting, epigastric distress, diarrhea, and convulsions. Oral rat LD<sub>50</sub> is over 20,000 mg/kg while intravenous rat LD<sub>50</sub> is over 7,000 mg/kg. |
|---|
- 1
- Overdosage may result in gastrointestinal disturbances and central nervous system convulsions
- 2
Cefotaxime 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.
Cefotaxime API manufacturers & distributors
Compare qualified Cefotaxime API suppliers worldwide. We currently have 15 companies offering Cefotaxime API, with manufacturing taking place in 7 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 | CEP, CoA, FDA, GMP, USDMF | 36 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, WC | 250 products |
| CSPC Zhongnuo | Producer | China | China | CEP, CoA, FDA | 6 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Hanmi Fine Chemical | Producer | South Korea | South Korea | CEP, CoA, GMP, KDMF | 18 products |
| Kopran R.L. | Producer | India | India | CoA, GMP, WC | 8 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| NCPC Hebei Huamin | Producer | China | China | CEP, CoA, GMP | 4 products |
| Qilu Antibiotics | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, WC | 33 products |
| Sandoz | Producer | Austria | Germany | CEP, CoA, FDA, GMP, KDMF, USDMF | 58 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sichuan Kelun Pharmaceuti... | Producer | China | China | CoA | 6 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA | 762 products |
When sending a request, specify which Cefotaxime 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 Cefotaxime 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.
