Ceftazidime API from South Korea Manufacturers & Suppliers
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Ceftazidime | CAS No: 72558-82-8 | GMP-certified suppliers
A medication that treats severe respiratory, skin, urinary, intra-abdominal, and central nervous system infections caused by susceptible bacteria, including complex Gram-negative cases across key markets.
Therapeutic categories
Primary indications
- Ceftazidime is indicated for the treatment of lower respiratory tract infections, skin and skin structure infections, urinary tract infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections (including peritonitis), and central nervous system infections (including meningitis) caused by susceptible bacteria
- Ceftazidime is indicated in combination with [avibactam] to treat infections caused by susceptible Gram-negative organisms, including complicated intra-abdominal infections (cIAI), in conjunction with [metronidazole], and complicated urinary tract infections (cUTI), including pyelonephritis, in patients aged three months and older
- This combination is also indicated to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older
Product Snapshot
- Ceftazidime is a parenteral cephalosporin API supplied as injectable powders and solutions for IV/IM use
- It is used for a broad range of susceptible bacterial infections, including respiratory, skin/soft tissue, urinary, intra‑abdominal, CNS, and for resistant Gram‑negative infections when combined with avibactam
- It is approved in major regulated markets including the US, Canada, and the EU
Clinical Overview
Ceftazidime exerts bactericidal activity through inhibition of penicillin‑binding proteins, with primary affinity for PBP3 in Gram‑negative organisms. This inhibition disrupts peptidoglycan cross‑linking, leading to loss of cell wall integrity. The compound demonstrates notable activity against Pseudomonas aeruginosa and other clinically relevant Gram‑negative species including Enterobacterales, Haemophilus influenzae, and Neisseria meningitidis. Activity against Gram‑positive organisms is limited compared with earlier‑generation cephalosporins, and intrinsic activity against anaerobes is low.
Following parenteral administration, ceftazidime distributes into extracellular fluids and achieves therapeutic concentrations in cerebrospinal fluid during meningeal inflammation. It is minimally metabolized and is primarily eliminated unchanged by the kidneys. Reduced renal function results in elevated and prolonged plasma concentrations, increasing the risk of neurotoxicity including seizures, encephalopathy, and neuromuscular excitability. Hypersensitivity reactions may occur, particularly in patients with β‑lactam allergy. As with other broad‑spectrum antibiotics, treatment may promote overgrowth of non‑susceptible organisms and Clostridioides difficile–associated diarrhea.
Ceftazidime is marketed globally in various parenteral formulations and as the fixed‑dose combination ceftazidime‑avibactam. For API procurement, suppliers should provide consistent impurity profiles, validated sterility controls, and confirmation of β‑lactam integrity to support formulation and regulatory requirements.
Identification & chemistry
| Generic name | Ceftazidime |
|---|---|
| Molecule type | Small molecule |
| CAS | 72558-82-8 |
| UNII | DZR1ENT301 |
| DrugBank ID | DB00438 |
Pharmacology
| Summary | Ceftazidime is a third‑generation cephalosporin that inhibits bacterial cell‑wall synthesis by binding key penicillin‑binding proteins, with primary activity at PBP3 in many Gram‑negative organisms. This blockade disrupts peptidoglycan cross‑linking and compromises cell integrity, producing bactericidal effects. Its pharmacology is characterized by broad Gram‑negative activity, relative stability to several β‑lactamases, and weaker activity against most Gram‑positive and anaerobic species. |
|---|---|
| Mechanism of action | The bacterial cell wall, which is located at the periphery of Gram-positive bacteria and within the periplasm of Gram-negative bacteria, comprises a glycopeptide polymer synthesized through cross-linking of glycans to peptide stems on alternating saccharides, which is known commonly as peptidoglycan.Cell wall formation, recycling, and remodelling require numerous enzymes, including a family of enzymes with similar active site character despite distinct and sometimes overlapping roles as carboxypeptidases, endopeptidases, transpeptidases, and transglycosylases, known as "penicillin-binding proteins" (PBPs). The number of PBPs differs between bacteria, in which some are considered essential and others redundant. In general, inhibition of one or more essential PBPs results in impaired cell wall homeostasis, loss of cell integrity, and is ultimately bactericidal. Ceftazidime is a semisynthetic third-generation cephalosporin with broad activity against numerous Gram-negative and some Gram-positive bacteria.Like other β-lactam antibiotics, ceftazidime exhibits its bactericidal effect primarily through direct inhibition of specific PBPs in susceptible bacteria._In vitro_ experiments in Gram-negative bacteria such as _Escherichia coli_, _Pseudomonas aeruginosa_, _Acinetobacter baumannii_, and _Klebsiella pneumoniae_ suggest that ceftazidime primarily binds to PBP3, with weaker binding to PBP1a/1b and PBP2 as well; although binding to other PBPs, such as PBP4, is detectable, the concentrations required are much greater than those achieved clinically.Similarly, ceftazidime showed binding to _Staphylococcus aureus_ PBP 1, 2, and 3 with a much lower affinity for PBP4.Recent data for _Mycobacterium abcessus_ suggest that ceftazidime can inhibit PonA1, PonA2, and PbpA at intermediate concentrations. |
| Pharmacodynamics | Ceftazidime is a semisynthetic, broad-spectrum, third-generation cephalosporin antibiotic that is bactericidal through inhibition of enzymes responsible for cell-wall synthesis, primarily penicillin-binding protein 3 (PBP3).Among cephalosporins, ceftazidime is notable for its resistance to numerous β-lactamases and its broad spectrum of activity against Gram-negative bacteria, including _Pseudomonas aeruginosa_.However, it is less active than first- and second-generation cephalosporins against _Staphylococcus aureus_ and other Gram-positive bacteria and also has low activity against anaerobes.Ceftazidime has confirmed activity against clinically relevant Gram-negative bacteria including _Citrobacter_ spp., _Enterobacter_ spp., _Klebsiella_ spp., _Proteus_ spp., _Serratia spp., _Escherichia coli_, _Haemophilus influenzae_, _Neisseria meningitidis_, _Pseudomonas aeruginosa_, and some Gram-positive bacteria including _Staphylococcus_ spp. and _Streptococcus_ spp. There are also _in vitro_ data for ceftazidime efficacy against a wide variety of other bacteria, such as _Acinetobacter baumannii_ and _Neisseria gonorrhoeae_, but no clear clinical studies to support the use of ceftazidime for infections caused by these bacteria. Although β-lactam antibiotics like ceftazidime are generally well tolerated, there remains a risk of serious acute hypersensitivity reactions, which is higher in patients with a known allergy to ceftazidime or any other β-lactam antibiotic. As with all antibiotics, ceftazidime may result in the overgrowth of non-susceptible organisms and potentially serious effects including _Clostridium difficile_-associated diarrhea (CDAD); CDAD should be considered in patients who develop diarrhea and, in confirmed cases, supportive care initiated immediately. Ceftazidime is primarily renally excreted such that high and prolonged serum concentrations can occur in patients with renal insufficiency, leading to seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Treatment may lead to the development or induction of resistance with a risk of treatment failure. Periodic susceptibility testing should be considered, and monotherapy failure may necessitate the addition of another antibiotic such as an aminoglycoside. Cephalosporin use may decrease prothrombin activity, which may be improved by exogenous vitamin K. Inadvertent intra-arterial administration of ceftazidime may result in distal necrosis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Peptidoglycan synthase FtsI | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 1A | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 1B | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Ceftazidime administered intravenously in healthy males produced mean C<sub>max</sub> values of between 42 and 170 μg/mL for doses between 500 mg and 2 g, and are reached immediately following the end of the infusion period.The C<sub>max</sub> for 1 g of ceftazidime administered intramuscularly is attained approximately one hour following injection and is between 37 and 43 mg/L.Following intramuscular administration of 500 mg and 1 g of ceftazidime, the serum concentration remained above 4 μg/mL for six and eight hours, respectively. Ceftazidime C<sub>max</sub> and AUC show linear proportionality to the dose over the therapeutic range.In individuals with normal renal function, ceftazidime given intravenously every eight hours for 10 days as either 1 or 2 g doses showed no accumulation. |
|---|---|
| Half-life | Ceftazidime has an elimination half-life of 1.5-2.8 hours in healthy subjects.As ceftazidime is primarily renally excreted, its half-life is significantly prolonged in patients with renal impairment.In patients with creatinine clearance < 12 mL/min, the half-life is prolonged to between 14 and 30 hours. |
| Protein binding | Ceftazidime plasma protein binding ranges from 5-22.8% (typically less than 10%) and is independent of concentration.Ceftazidime has been shown to bind human serum albumin. |
| Metabolism | Ceftazidime is not appreciably metabolized. |
| Route of elimination | Approximately 80% to 90% of an intramuscular or intravenous dose of ceftazidime is excreted unchanged by the kidneys over a 24-hour period. When administered intravenously, 50% of the dose appears in the urine within two hours, with another 32% of the dose appearing by eight hours post-administration. |
| Volume of distribution | Ceftazidime has a volume of distribution of 15-20 L. |
| Clearance | The mean renal clearance of ceftazidime in healthy subjects ranges from 72 to 141 mL/min while the calculated plasma clearance is approximately 115 mL/min. |
Formulation & handling
- Formulated exclusively for parenteral use; supplied as a lyophilized powder requiring reconstitution for IM or IV administration due to poor oral bioavailability.
- Highly hydrophilic small‑molecule cephalosporin; low logP and modest aqueous solubility necessitate appropriate diluents to ensure complete dissolution before use.
- Solution stability is limited by hydrolysis of the β‑lactam ring, so reconstituted solutions require controlled pH and timely use to maintain potency.
Regulatory status
| Lifecycle | Several early U.S. patents have expired while others extend through 2030–2031, indicating a product transitioning from partial loss of exclusivity toward a later stage of its lifecycle. With availability across the US, Canada, and the EU, the API is marketed in mature regions where competition is expected to increase as remaining protections expire. |
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| Markets | US, Canada, EU |
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Supply Chain
| Supply chain summary | Ceftazidime is produced and packaged by multiple established pharmaceutical manufacturers, indicating no single dominant originator and a mature, widely distributed supply base. Branded and unbranded products are marketed across the US, Canada, and the EU, reflecting broad global availability. While core ceftazidime substance patents have long expired, the presence of later‑expiring US patents related to specific formulations or combinations suggests that most forms face existing generic competition, with some protected presentations remaining under patent. |
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Safety
| Toxicity | Ceftazidime overdosage has occurred in patients with renal failure. Reactions included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body. |
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- Overexposure has been associated with neurotoxic manifestations such as seizures, encephalopathy, asterixis, neuromuscular excitability, and coma, with increased risk under renal impairment
- Accumulation may occur in reduced renal function
- Dialysis procedures can enhance clearance, indicating relevance for process design and impurity or residual‑risk assessments
Ceftazidime 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.
Ceftazidime API manufacturers & distributors
Compare qualified Ceftazidime API suppliers worldwide. We currently have 14 companies offering Ceftazidime 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, USDMF | 36 products |
| Antibióticos do Brasila | Producer | Brazil | Brazil | CEP, CoA, GMP | 3 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 |
| CJ CheilJedang | Producer | South Korea | South Korea | CoA, JDMF | 2 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Glaxosmithkline | Producer | United Kingdom | United Kingdom | CEP, CoA, GMP, USDMF | 19 products |
| Hanmi Fine Chemical | Producer | South Korea | South Korea | CEP, CoA, GMP | 18 products |
| Parabolic Drugs | Producer | India | India | CoA, USDMF | 11 products |
| Qilu Antibiotics | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 33 products |
| Sandoz | Producer | Austria | Unknown | CEP, CoA, FDA, GMP, USDMF | 58 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Solvay Operations | Producer | France | France | CEP, CoA, GMP | 2 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Yungjin Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 10 products |
When sending a request, specify which Ceftazidime 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 Ceftazidime 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.
