Imipenem API Manufacturers & Suppliers
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Imipenem | CAS No: 64221-86-9 | GMP-certified suppliers
A medication that treats a wide range of severe bacterial infections, including respiratory, urinary, skin, intra-abdominal, septicemia, and endocarditis, with broad-spectrum antibacterial activity.
Therapeutic categories
Primary indications
- Imipenem is indicated, in combination with [cilastatin] with or without [relebactam], for the treatment of bacterial infections including respiratory, skin, bone, gynecologic, urinary tract, and intra-abdominal as well as septicemia and endocarditis
Product Snapshot
- Imipenem is available as a parenteral injectable small molecule antibiotic in powder and solution forms
- It is indicated for bacterial infections across multiple systems including respiratory, skin, bone, gynecologic, urinary tract, intra-abdominal infections, septicemia, and endocarditis
- Imipenem is approved for use in key regulatory markets including the US, Canada, and the EU
Clinical Overview
Clinically, imipenem is indicated for the treatment of various bacterial infections including respiratory tract infections, skin and soft tissue infections, bone and joint infections, gynecologic infections, urinary tract infections, intra-abdominal infections, septicemia, and endocarditis. It is typically administered in combination with cilastatin, a renal dehydropeptidase inhibitor that prevents imipenem degradation in the kidneys, thereby enhancing its bioavailability and reducing nephrotoxic metabolites. More recently, imipenem has been formulated with cilastatin and relebactam, a beta-lactamase inhibitor, which broadens its activity against resistant pathogens.
Pharmacodynamically, imipenem exerts bactericidal effects through inhibition of bacterial cell wall synthesis. It binds with high affinity to penicillin-binding proteins (PBPs), primarily PBP-2, PBP-1a, and PBP-1b in Escherichia coli and selected strains of Pseudomonas aeruginosa. This binding hinders peptidoglycan polymer cross-linking essential for cell wall integrity, leading to bacterial cell lysis and death.
Imipenem demonstrates stability against many beta-lactamases, contributing to its effectiveness against beta-lactamase-producing organisms. Its pharmacokinetics are affected by rapid renal clearance, which necessitates co-administration with cilastatin. Key ADME considerations include renal excretion and the prevention of renal metabolism to maintain therapeutic plasma concentrations.
Safety concerns primarily relate to neurotoxicity, including a potential to reduce the seizure threshold, particularly in patients with central nervous system disorders or renal impairment. Careful dose adjustments are required in cases of renal dysfunction.
Imipenem was first approved by the FDA in 1985 as part of the combination product Primaxin (imipenem/cilastatin) marketed by Merck & Co. It remains an important option in hospital settings for severe and resistant bacterial infections.
When sourcing imipenem API, it is critical to ensure compliance with established pharmacopeial standards for purity, residual solvents, and related substances. Reliable suppliers should provide comprehensive documentation, including certificates of analysis and stability data, to support regulatory submissions and quality assurance.
Identification & chemistry
| Generic name | Imipenem |
|---|---|
| Molecule type | Small molecule |
| CAS | 64221-86-9 |
| UNII | Q20IM7HE75 |
| DrugBank ID | DB01598 |
Pharmacology
| Summary | Imipenem is a carbapenem beta-lactam antibiotic that exerts bactericidal activity by inhibiting bacterial cell wall synthesis. It targets penicillin-binding proteins (PBPs), particularly PBP-1a, PBP-1b, and PBP-2 in Gram-negative bacteria, disrupting peptidoglycan cross-linking and leading to cell death. Its spectrum includes aerobic and anaerobic Gram-positive and Gram-negative pathogens, including Pseudomonas aeruginosa and Enterococcus species. |
|---|---|
| Mechanism of action | Imipenem acts as an antimicrobial through the inhibition of cell wall synthesis of various gram-positive and gram-negative bacteria. This inhibition of cell wall synthesis in gram-negative bateria is attained by binding to penicillin-binding proteins (PBPs). In E. coli and selected strains of P. aeruginosa, imipenem has shown to have the highest affinity to PBP-2, PBP-1a, and PBP-1b. This inhibition of PBPs prevents the bacterial cell from adding to the peptidoglycan polymer which forms the bacterial cell wall eventually leading to cell death. |
| Pharmacodynamics | Imipenem is a beta-lactam antibiotic belongings to the subgroup of carbapenems. Imipenem is active against aerobic and anaerobic Gram positive as well as Gram negative bacteria including <i>Pseudomonas aeruginosa</i> and the <i>Enterococcus</i>. It exerts a bactericidal effects by disrupting cell wall synthesis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 2 | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 1B | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 1A | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Imipenem is not effectively absorbed from the gastrointestinal tract and therefore must be administered parenterally. The bioavailability of the IM injection is 89%. |
|---|---|
| Half-life | When given via IV injection imipenem has a half-life of 1 h.[label,A2530,A181271] The apparent half-life of the IM injection ranges from 1.3-5.1 h, likely due to slower absorption form the injection site. |
| Protein binding | Imipenem is 20% bound to plasma proteins. [label,L7526] |
| Metabolism | Imipenem is metabolized by renal dehydropeptidase.[label,L7526] |
| Route of elimination | Approximately 70% of imipenem is excreted in the urine as the parent drug.[label,L7526] |
| Volume of distribution | The reported volume of distribution for imipenem ranges from 0.23-0.31 L/kg.[label,A2530,A181271] |
| Clearance | The total clearance of imipenem is 0.2 L/h/kg. When used alone, the renal clearance is 0.05 L/h/kg. In combination with cilastatin the renal clearance of imipenem is 0.15 L/h/kg, likely due to the increased concentration of the parent drug. |
Formulation & handling
- Imipenem is a small molecule beta-lactam antibiotic formulated primarily for parenteral use, including intravenous and intramuscular injections.
- This API presents low lipophilicity (LogP -3.9) and moderate water solubility, requiring consideration of stable aqueous formulations for injection.
- Handling should ensure protection from moisture and degradation, as beta-lactam rings are susceptible to hydrolysis under inappropriate storage conditions.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is protected by a patent in the United States until November 19, 2029. It is currently marketed in the US, Canada, and the EU, with market maturity expected to increase following patent expiry. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Imipenem involves multiple originator companies with branded products available across the US, Canada, and EU markets. Several formulations, including combinations with Cilastatin, are marketed under brand names. The existing patent in the United States, expiring in November 2029, indicates that generic competition is currently limited but may increase post-patent expiry. |
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Safety
| Toxicity | In case of overdose with the combination product, including [relebactam] and [cilastatin], it is recommended to provide supportive care. Imipenem, cilastatin, and relebactam may be removed via hemodialysis. |
|---|
- Overdose may require supportive care interventions
- Monitoring for toxicity is advised
- Imipenem, cilastatin, and relebactam are dialyzable and can be removed via hemodialysis
Imipenem is a type of Carbapenems
Carbapenems are a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the field of medicine. These powerful antibiotics are highly effective against a broad spectrum of bacteria, including multidrug-resistant strains. Carbapenems exhibit a unique molecular structure that makes them resistant to enzymatic degradation by most β-lactamases, enzymes produced by bacteria to break down β-lactam antibiotics.
Carbapenems work by inhibiting bacterial cell wall synthesis, leading to cell lysis and ultimately killing the bacteria. They are administered intravenously or intramuscularly and are often reserved for serious infections caused by bacteria resistant to other antibiotics.
Some commonly used carbapenems include imipenem, meropenem, and doripenem. These drugs are prescribed in hospitals for the treatment of severe infections such as complicated urinary tract infections, intra-abdominal infections, and pneumonia.
It is important to note that the use of carbapenems should be carefully monitored due to the emergence of carbapenem-resistant bacteria. The overuse or misuse of these antibiotics can contribute to the development of drug-resistant strains, posing a significant challenge in healthcare settings.
In conclusion, carbapenems are a vital subcategory of pharmaceutical APIs used to combat bacterial infections. Their unique molecular structure and broad-spectrum activity make them effective against various drug-resistant bacteria. However, responsible use and surveillance are crucial to prevent the emergence of resistant strains and ensure the continued efficacy of these important antibiotics.
Imipenem (Carbapenems), classified under Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Imipenem API manufacturers & distributors
Compare qualified Imipenem API suppliers worldwide. We currently have 5 companies offering Imipenem API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS | 243 products |
| JW Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 7 products |
| Socosur | Distributor | France | Unknown | CoA | 21 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP | 219 products |
| Zhuhai United Labs | Producer | China | China | CoA, GMP | 12 products |
When sending a request, specify which Imipenem 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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