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Gentamicin | CAS No: 1403-66-3 | GMP-certified suppliers
A medication that treats serious gram‑negative infections and supports topical ocular and otic care, suitable for systemic and localized anti‑infective applications.
Therapeutic categories
Product Snapshot
- Gentamicin is supplied as injectable small‑molecule antibiotic formulations as well as topical, ophthalmic, and otic presentations
- It is used for bacterial infection control across systemic, ocular, dermatologic, and otic applications
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Gentamicin exerts concentration‑dependent bactericidal activity. Entry into bacterial cells follows three phases. Initial ionic binding occurs when the polycationic molecule associates with negatively charged membrane components, displacing divalent cations and increasing membrane permeability. Energy‑dependent phase I allows limited cytoplasmic entry via the proton‑motive force, enabling interaction with the 30S ribosomal subunit and initiation of protein mistranslation. Energy‑dependent phase II reflects rapid intracellular accumulation due to membrane damage, amplifying protein synthesis inhibition and leading to bactericidal effects. Oxygen dependence of active transport explains the lack of activity against anaerobic bacteria.
At the molecular level, gentamicin binds to 16S rRNA in helix 44 near the A site, displacing residues A1492 and A1493 and inducing conformational changes that interfere with normal decoding. This results in impaired initiation, elongation, and ribosome recycling. Experimental evidence also suggests a second binding site in helix 69 of 23S rRNA, contributing to downstream inhibition. Mistranslated proteins may integrate into membranes, reinforcing permeability defects.
Gentamicin is eliminated primarily by renal excretion and displays a narrow therapeutic index. Accumulation increases the risk of nephrotoxicity and irreversible ototoxicity, particularly with prolonged courses, pre‑existing renal impairment, or concurrent nephrotoxic agents. Gentamicin can also potentiate neuromuscular blockade in susceptible individuals.
In practice, gentamicin is available as injectable solutions and as topical ophthalmic or otic formulations. For API procurement, sourcing should prioritize suppliers with demonstrated control of impurity profiles, consistent potency across sulfate complex components, and validated manufacturing processes compliant with pharmacopeial and regulatory standards.
Identification & chemistry
| Generic name | Gentamicin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1403-66-3 |
| UNII | T6Z9V48IKG |
| DrugBank ID | DB00798 |
Pharmacology
| Summary | Aminoglycosides act primarily by binding to 16S rRNA within the 30S ribosomal subunit, disrupting decoding fidelity and inhibiting multiple steps of bacterial protein synthesis; additional binding to 23S rRNA may impair ribosome recycling. Entry into bacterial cells occurs through sequential membrane‑associated and energy‑dependent phases, leading to membrane disruption, error‑prone translation, and concentration‑dependent bactericidal activity. Overall, their pharmacology reflects combined effects on membrane integrity and inhibition of translational machinery. |
|---|---|
| Mechanism of action | There are 3 key phases of aminoglycoside entry into cells.The first “ionic binding phase” occurs when polycationic aminoglycosides bind electrostatically to negatively charged components of bacterial cell membranes including with lipopolysaccharides and phospholipids within the outer membrane of Gram-negative bacteria and to teichoic acids and phospholipids within the cell membrane of Gram-positive bacteria. This binding results in displacement of divalent cations and increased membrane permeability, allowing for aminoglycoside entry. The second “energy-dependent phase I” of aminoglycoside entry into the cytoplasm relies on the proton-motive force and allows a limited amount of aminoglycoside access to its primary intracellular target - the bacterial 30S ribosome.This ultimately results in the mistranslation of proteins and disruption of the cytoplasmic membrane.Finally, in the “energy-dependent phase II” stage, concentration-dependent bacterial killing is observed. Aminoglycoside rapidly accumulates in the cell due to the damaged cytoplasmic membrane, and protein mistranslation and synthesis inhibition is amplified.The necessity of oxygen-dependent active transport explains why aminoglycosides are ineffective against anaerobic bacteria. Hence, aminoglycosides have both immediate bactericidal effects through membrane disruption and delayed bactericidal effects through impaired protein synthesis; observed experimental data and mathematical modeling support this two-mechanism model. Inhibition of protein synthesis is a key component of aminoglycoside efficacy. Structural and cell biological studies suggest that aminoglycosides bind to the 16S rRNA in helix 44 (h44), near the A site of the 30S ribosomal subunit, altering interactions between h44 and h45. This binding also displaces two important residues, A1492 and A1493, from h44, mimicking normal conformational changes that occur with successful codon-anticodon pairing in the A site.Overall, aminoglycoside binding has several negative effects including inhibition of translation, initiation, elongation, and ribosome recycling.Recent evidence suggests that the latter effect is due to a cryptic second binding site situated in h69 of the 23S rRNA of the 50S ribosomal subunit.Also, by stabilizing a conformation that mimics correct codon-anticodon pairing, aminoglycosides promote error-prone translation.Mistranslated proteins can incorporate into the cell membrane, inducing the damage discussed above. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S12 | Escherichia coli (strain K12) | binder |
| 16S ribosomal RNA | Enteric bacteria and other eubacteria | binder |
| 23S ribosomal RNA | Enteric bacteria and other eubacteria | inhibitor |
ADME / PK
| Half-life | One study assessing the pharmacokinetics of gentamicin in children and adults reported a mean half-life of 75 minutes after intravenous administration.The mean half-life associated with intramuscular administration was about 29 minutes longer.Fever and anemia may result in a shorter half-life although dose adjustments are not usually necessary.Severe burns are also associated with a shorter half-life and may result in lower gentamicin serum concentrations. |
|---|---|
| Protein binding | Studies have determined that plasma protein binding of gentamicin is between 0-30% depending on the method of testing. |
| Metabolism | Gentamicin undergoes little to no metabolism. |
| Route of elimination | Gentamicin is excreted primarily by the kidneys. In patients with normal renal function, 70% or more of an initial gentamicin dose can be recovered in the urine within 24 hours. Excretion of gentamicin is significantly reduced in patients with renal impairment. |
| Clearance | The renal clearance of gentamicin is comparable to individual creatinine clearance. |
Formulation & handling
- Gentamicin is a highly water‑soluble, hydrophilic small molecule aminoglycoside suited for aqueous parenteral, ophthalmic, otic, and topical formulations.
- Parenteral solutions require control of pH (typically acidic) to maintain stability and solubility, and the API is heat‑stable enough for standard sterilization processes.
- Topical and ophthalmic products generally use simple aqueous or semi‑solid bases, with minimal risk of food effects since the drug is not orally administered.
Regulatory status
| Lifecycle | With patents largely expired or nearing expiry, the API is in a mature stage of its lifecycle. Availability in both the US and Canada indicates an established market with broad generic participation. |
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| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Gentamicin is supplied by a large number of long‑established manufacturers and packagers, indicating a highly genericized market rather than dependence on a single originator. The product is widely available in the US and Canada across multiple branded and unbranded presentations. Patent expiry occurred decades ago, and the extensive manufacturer list reflects mature, ongoing generic competition. |
|---|
Safety
| Toxicity | As with other aminoglycosides, nephrotoxicity and ototoxicity are associated with gentamicin.Signs of nephrotoxicity include an increase in plasma creatinine and urea, while signs of ototoxicity include issues with balance, nausea, tinnitus, and hearing loss.It is important to note that aminoglycoside-induced nephrotoxicity is typically reversible, while ototoxicity is more likely to be permanent.The risk of both toxicities increases with long-term gentamicin therapy.Gentamicin is considered to be more vestibulotoxic than cochleotoxic compared to other aminoglycosides.Unfortunately, gentamicin-related ototoxicity does not correlate with cumulative dosing, peak and trough levels, or dosing schedule.The unpredictability of ototoxicity supports close monitoring of the patient throughout treatment.In cases of toxicity or overdose, the medication should be discontinued immediately; hemodialysis may be initiated to lower gentamicin serum concentrations. |
|---|
- Gentamicin exhibits characteristic aminoglycoside-associated nephrotoxicity, reflected by elevations in plasma creatinine and urea
- This effect is typically reversible and increases in likelihood with prolonged exposure
- Ototoxicity is a major toxicity concern and may be irreversible
Gentamicin is a type of Aminoglycosides
Aminoglycosides are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in combating bacterial infections. These powerful antibiotics are primarily used to treat severe infections caused by gram-negative bacteria. Aminoglycosides are characterized by their unique chemical structure, consisting of amino sugars and a glycosidic bond.
These antibiotics exert their therapeutic effects by inhibiting bacterial protein synthesis, leading to the disruption of essential cellular functions in the bacteria. This mechanism of action makes aminoglycosides highly effective against a wide range of bacteria, including those that have developed resistance to other classes of antibiotics.
Key examples of aminoglycosides include gentamicin, amikacin, and tobramycin. These drugs are typically administered intravenously or intramuscularly to ensure optimal absorption and distribution throughout the body. Due to their limited oral bioavailability, aminoglycosides are not commonly administered orally.
Although aminoglycosides possess potent antimicrobial properties, they are associated with some potential adverse effects, including nephrotoxicity and ototoxicity. Regular monitoring of kidney function and therapeutic drug monitoring are often recommended during aminoglycoside therapy to minimize the risk of these complications.
In summary, aminoglycosides are an important subcategory of pharmaceutical APIs that have significant therapeutic value in the treatment of severe bacterial infections. Their unique mechanism of action and broad spectrum of activity make them valuable tools in the fight against antibiotic-resistant bacteria.
Gentamicin (Aminoglycosides), 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.
Gentamicin API manufacturers & distributors
Compare qualified Gentamicin API suppliers worldwide. We currently have 7 companies offering Gentamicin 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 |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Fujian Fukang Pharma | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 4 products |
| Lek Pharma | Producer | Slovenia | Unknown | CEP, CoA, GMP, JDMF, USDMF | 32 products |
| Quimdis | Distributor | France | Unknown | CoA | 17 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001 | 762 products |
| Yantai Justaware | Producer | China | China | CoA, WC | 2 products |
When sending a request, specify which Gentamicin 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 Gentamicin 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.
Frequently asked questions about Gentamicin API
Sourcing
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Technical
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Regulatory
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