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Neomycin | CAS No: 1404-04-2 | GMP-certified suppliers
A medication that supports hepatic encephalopathy management and treats susceptible superficial ear, eye, and skin infections across key clinical settings.
Therapeutic categories
Primary indications
- Oral neomycin sulfate is indicated as an adjunctive therapy in hepatic coma (portal-system encephalopathy) by reducing ammonia-forming bacteria in the intestinal tract
- It is strongly recommended that oral neomycin is only used in infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the risk of the development of drug-resistant bacteria
- Neomycin, in combination with polymyxin B sulfates and hydrocortisone in otic suspensions, is used in the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the antibiotics
Product Snapshot
- Neomycin is supplied as an oral small‑molecule aminoglycoside and in multiple topical, otic, and ophthalmic combination formulations
- It is used for reducing intestinal ammonia‑forming bacteria in hepatic coma and for managing susceptible bacterial infections in external ear and ocular applications
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Oral neomycin sulfate is indicated as adjunctive therapy in hepatic coma by reducing intestinal ammonia‑producing bacteria. Its use is restricted to infections proven or strongly suspected to involve susceptible organisms to limit resistance development. Topical, otic, and ophthalmic formulations are widely used in combination with polymyxin B and corticosteroids to manage superficial infections of the external auditory canal and steroid‑responsive ocular inflammatory conditions where bacterial risk is present. Over‑the‑counter topical products also use neomycin for prevention of minor skin infections.
Neomycin exerts bactericidal activity through binding to the 30S ribosomal subunit and disrupting bacterial protein synthesis. It is active against many gram‑positive and gram‑negative bacteria, including common and enteropathogenic Escherichia coli and species within the Klebsiella‑Enterobacter group. Activity extends to some protozoa, while fungi are not susceptible. Resistant strains of Enterobacteriaceae may emerge during therapy.
After oral administration, systemic absorption is minimal, and bactericidal activity persists for 48 to 72 hours within the gastrointestinal tract. The drug is primarily renally eliminated when absorbed. As with other aminoglycosides, neomycin carries risks of nephrotoxicity, ototoxicity, and neurotoxicity, particularly with prolonged exposure or elevated systemic levels. Neuromuscular blockade may occur in susceptible individuals.
Common usage contexts include hepatic encephalopathy management, otic anti‑infective combinations, and ophthalmic anti‑infective corticosteroid combinations.
For API procurement, suppliers should ensure consistent neomycin component ratios, validated potency determinations in units, and strict control of impurities and endotoxin due to the product’s narrow therapeutic index and potential toxicity.
Identification & chemistry
| Generic name | Neomycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1404-04-2 |
| UNII | I16QD7X297 |
| DrugBank ID | DB00994 |
Pharmacology
| Summary | Neomycin is an aminoglycoside antibiotic that binds the 30S ribosomal subunit, disrupting bacterial translation and inhibiting protein synthesis. Its pharmacodynamic effect is bactericidal, reducing viable gram‑positive and gram‑negative organisms, including intestinal bacteria that generate ammonia. Activity is driven by interactions with 16S rRNA and ribosomal protein S12, with resistance possible among some Enterobacterales species. |
|---|---|
| Mechanism of action | Like other aminoglycoside antibiotic drugs, neomycin inhibits bacterial ribosomes by binding to the 30S ribosomal subunit of susceptible bacteria and disrupting the translational machinery of bacterial protein synthesis.Bacterial translation is normally initiated by the mRNA binding to the 30S ribosomal subunit and subsequent binding with 50S subunit for elongation. |
| Pharmacodynamics | Neomycin mediates its bactericidal action by inhibiting bacterial protein synthesis, thereby suppressing the growth and survival of susceptible bacteria. Following oral administration, the duration of bactericidal activity of neomycin ranged from 48 to 72 hours.By decreasing colonic bacteria that produce ammonia, neomycin was shown to be effective as an adjunctive therapy in hepatic coma to improve neurologic symptoms. Neomycin is active against both gram positive and gram negative organisms, including the major _E. coli_ species resident in the colon as well as the enteropathogenic forms of _E. coli_.It is also active against _Klebsiella_-_Enterobacter_ group.Resistant strains of _E. coli_, _Klebsiella_ and _Proteus spp_. may emerge from neomycin therapy.Neomycin has no antifungal activity and has some activity against some protozoa. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S12 | Escherichia coli (strain K12) | inhibitor |
| 16S ribosomal RNA | Enteric bacteria and other eubacteria | inhibitor |
| Extracellular calcium-sensing receptor | Humans |
ADME / PK
| Absorption | Neomycin is poorly absorbed from the gastrointestinal tract. Gastrointestinal absorption of the drug may be increased if inflammatory or ulcerative gastrointestinal disease is present. |
|---|---|
| Half-life | There is limited information on the half-life of neomycin. |
| Protein binding | Findings from protein binding studies suggest low protein binding profile for neomycin sulfate, which can range from 0-30% depending on test methods. |
| Metabolism | There is limited information on the metabolism of neomycin, as there is limited systemic absorption following drug administration. Metabolism is deemed to be negligible. |
| Route of elimination | The small absorbed fraction of neomycin is excreted by the kidney. The unabsorbed portion of the drug is excreted unchanged in the feces. |
| Volume of distribution | The small fraction of absorbed neomycin is rapidly distributed in the tissues. The amount of systemically absorbed neomycin is reported to increase cumulatively with each repeated dose administered until a steady state is reached. |
| Clearance | There is limited information on the clearance rate of neomycin. |
Formulation & handling
- Oral formulations show minimal systemic absorption, so tablets and solutions are typically designed without reliance on systemic bioavailability and may tolerate simple excipient systems.
- Topical, ophthalmic, otic, and inhalation products require attention to local tolerability and preservative compatibility, with the API stable as a solid but sensitive to oxidative degradation in aqueous media.
- Irrigation, inhalation, and ophthalmic solutions benefit from controlled pH and osmolarity to maintain activity and reduce tissue irritation, with avoidance of polyvalent cations that can reduce antimicrobial potency.
Regulatory status
| Lifecycle | Patent‑driven market maturity in the US and Canada will depend on the API’s remaining exclusivity period; once key patents expire, these markets typically transition to generic competition quickly. Overall lifecycle position should be assessed based on confirmed loss‑of‑exclusivity dates and current competitive activity in both regions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Neomycin is an established, off‑patent antibiotic with multiple historic originator companies and a wide base of current manufacturers, indicating a mature and diversified supply landscape. Branded and private‑label products are broadly distributed in the US and Canada, mainly in topical and first‑aid formats. Patent expiry long ago has enabled extensive generic competition, which now dominates the market. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> of neomycin sulfate in mouse is > 8 g/kg. The subcutaneous LD<sub>50</sub> is 200 mg/kg in rat and 190 mg/kg in mouse. The intraperitoneal LD<sub>50</sub> in mouse is 305 mg/kg. The oral Lowest published toxic dose (TDLo) in woman is 12600 mg/kg/7D. Because of low absorption, acute overdosage from oral neomycin is not likely to occur. However, prolonged administration of neomycin should be avoided because of the possibility of some systemic absorption and the risk of neurotoxicity, ototoxicity, and/or nephrotoxicity. Hemodialysis will remove neomycin from the blood. While nephrotoxicity and ototoxicity have been reported in otherwise patients without compromised renal function, the risk for developing these toxicities is increased in patients with renal impairment.Like other aminoglycosides, neomycin may cause fetal harm and total irreversible bilateral congenital deafness when administered in pregnant women. |
|---|
- High acute toxicity via parenteral routes, with subcutaneous LD50 values near 200 mg/kg in rodents, contrasts with very low systemic exposure after oral dosing
- Prolonged or systemic exposure is associated with characteristic aminoglycoside class risks, including nephrotoxicity, ototoxicity, and neurotoxicity
- Fetal ototoxicity has been reported
Neomycin 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.
Neomycin (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.
Neomycin API manufacturers & distributors
Compare qualified Neomycin API suppliers worldwide. We currently have 6 companies offering Neomycin API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Duchefa Farma B.V. | Distributor | Netherlands | United States | CoA, GMP, ISO9001, MSDS | 170 products |
| Huashu Pharmaceutical | Producer | China | China | CoA, USDMF | 2 products |
| Pharmacia & Upjohn | Producer | United States | United States | CEP, CoA, FDA, GMP, USDMF | 30 products |
| Shandong Qilu King-Phar | Producer | China | China | CEP, CoA, GMP | 3 products |
| Sichuan Long March | Producer | China | China | CEP, CoA, FDA, GMP | 3 products |
| Yichang Sanxia | Producer | China | China | CEP, CoA, FDA, USDMF | 1 products |
When sending a request, specify which Neomycin 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 Neomycin 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.
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Technical
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