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Amoxicillin | CAS No: 26787-78-0 | GMP-certified suppliers
A medication that treats common bacterial infections of the respiratory tract, ear, skin, urinary system, and supports combination regimens for Helicobacter pylori eradication in clinical practice.
Therapeutic categories
Primary indications
- Amoxicillin alone is indicated to treat susceptible bacterial infections of the ear, nose, throat, genitourinary tract, skin, skin structure, and lower respiratory tract
- Amoxicillin is given with calvulanic acid to treat acute bacterial sinusitis, community acquired pneumonia, lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, and urinary tract infections
- Amoxicillin is given with omeprazole in the treatment of _Helicobacter pylori_ (_H
- Pylori_) infection
Product Snapshot
- Amoxicillin is an oral and parenteral small‑molecule beta‑lactam supplied in extensive solid, liquid, and injectable formulations
- It is used for a broad range of susceptible bacterial infections and is also included in combination regimens for Helicobacter pylori
- It is approved in major markets including the US and Canada, with both human and veterinary approvals
Clinical Overview
Clinically, amoxicillin is indicated for infections of the ear, nose, throat, lower respiratory tract, genitourinary system, and skin and skin structures. In combination with clavulanic acid, it extends coverage to beta‑lactamase–producing organisms and is used in acute bacterial sinusitis, community‑acquired pneumonia, otitis media, and urinary tract infections. Amoxicillin is also part of multidrug regimens for Helicobacter pylori eradication, co‑packaged with agents such as omeprazole, vonoprazan, and clarithromycin.
Pharmacologically, amoxicillin is a beta‑lactam antibiotic that inhibits bacterial cell wall synthesis. It binds competitively to penicillin‑binding protein 1 and other high‑molecular‑weight PBPs, blocking glycosyltransferase and transpeptidase reactions required for peptidoglycan cross‑linking. This disruption triggers autolytic enzyme activation, resulting in bactericidal activity. Serum concentrations tend to be higher than those achieved with ampicillin under comparable dosing conditions.
Absorption after oral administration is reliable, and the drug is widely distributed in extracellular fluids. It is primarily eliminated unchanged by the kidney, consistent with its classification as a drug mainly renally excreted. The usual twice‑daily dosing reflects a moderate elimination half‑life and sustained therapeutic levels.
Safety considerations include the risk of hypersensitivity reactions, particularly in individuals with penicillin allergy. Clinicians monitor for Clostridium difficile–associated diarrhea and the potential for selection of resistant organisms. Overdose is generally associated with low acute toxicity but may increase gastrointestinal symptoms.
Common reference products include amoxicillin capsules, tablets, chewable forms, and oral suspensions, as well as fixed‑dose combinations with clavulanic acid.
For API procurement, suppliers should provide evidence of compliance with pharmacopeial specifications, validated impurity controls, and robust microbial and beta‑lactam cross‑contamination safeguards.
Identification & chemistry
| Generic name | Amoxicillin |
|---|---|
| Molecule type | Small molecule |
| CAS | 26787-78-0 |
| UNII | 9EM05410Q9 |
| DrugBank ID | DB01060 |
Pharmacology
| Summary | Amoxicillin is a beta‑lactam antibiotic that exerts its effect by competitively inhibiting penicillin‑binding proteins, particularly PBP1, which mediate key glycosyltransferase and transpeptidase steps in bacterial cell‑wall synthesis. This blockade prevents proper peptidoglycan cross‑linking and triggers autolytic enzyme activity, resulting in bactericidal disruption of the cell wall. Its pharmacologic profile reflects targeted activity against susceptible bacteria that rely on these high‑molecular‑weight PBPs for cell‑wall integrity. |
|---|---|
| Mechanism of action | Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin binding proteins.Penicillin bind proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls.Without the action of penicillin binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action. |
| Pharmacodynamics | Amoxicillin competitively inhibit penicillin binding proteins, leading to upregulation of autolytic enzymes and inhibition of cell wall synthesis.Amoxicillin has a long duration of action as it is usually given twice daily.Amoxicillin has a wide therapeutic range as mild overdoses are not associated with significant toxicity.Patients should be counselled regarding the risk of anaphylaxis, _Clostridium difficile_ infections, and bacterial resistance. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin binding protein | Helicobacter pylori | inhibitor |
ADME / PK
| Absorption | Amoxicillin is approximately 60% bioavailable.A 250mg dose of oral amoxicillin reaches a C<sub>max</sub> 3.93±1.13mg/L with a T<sub>max</sub> 1.31±0.33h and an AUC of 27.29±4.72mg\*h/L.A 875mg dose of oral amoxicillin reaches a C<sub>max</sub> 11.21±3.42mg/L with a T<sub>max</sub> 1.52±0.40h and an AUC of 55.04±12.68mg\*h/L. |
|---|---|
| Half-life | The half life of amoxicillin is 61.3 minutes. |
| Protein binding | Amoxicillin is 17% protein bound in serum. |
| Metabolism | Incubation with human liver microsomes has lead to the detection of 7 metabolites.The M1 metabolite has undergone hydroxylation, M2 has undergone oxidative deamination, M3 to M5 have undergone oxidation of the aliphatic chain, M6 has undergone decarboxylation, and M7 has undergone glucuronidation. |
| Route of elimination | 125mg to 1g doses of amoxicillin are 70-78% eliminated in the urine after 6 hours. |
| Volume of distribution | The central volume of distribution of amoxicillin is 27.7L. |
| Clearance | The mean clearance of amoxicillin is 21.3L/h. |
Formulation & handling
- Amoxicillin is a small‑molecule β‑lactam suitable for both oral and parenteral formulations, with high aqueous solubility supporting solutions, suspensions, and reconstitution powders.
- The β‑lactam ring is hydrolytically labile, requiring protection from moisture and controlled pH during processing, storage, and reconstitution.
- Oral products are typically taken with food, which can improve gastrointestinal tolerance without materially impacting absorption.
Regulatory status
| Lifecycle | Most U.S. patents covering the API expired in 2020, with remaining protections ending between 2026 and 2027, indicating a transition toward late‑lifecycle status. With availability in the United States and Canada, the market is entering a mature phase as key exclusivities near completion. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Amoxicillin is an established antibiotic with no single dominant originator in current supply chains and a large number of packagers and generic manufacturers supporting broad commercial availability. Branded and combination products appear in the US and Canada, but core amoxicillin products are widely supplied as generics globally. The listed patents extend into 2026–2027 but relate to specific formulations, and base‑compound patent expiry has already enabled extensive generic competition. |
|---|
Safety
| Toxicity | Patients experiencing an overdose may present with hematuria, oliguria, abdominal pain, acute renal failure, vomiting, diarrhea, rash, hyperactivity, and drowsiness.Treat overdose with symptomatic and supportive treatment, which may include emesis or hemodialysis. |
|---|
- Overdose has been associated with renal effects such as hematuria, oliguria, and acute renal failure, along with gastrointestinal distress and CNS symptoms including hyperactivity and drowsiness
- Significant exposure may require interventions such as emesis induction or hemodialysis in controlled clinical settings due to limited intrinsic clearance under high systemic burden
- Materials handling should account for potential skin and gastrointestinal irritation, with controls to prevent accidental ingestion or high-dose exposure
Amoxicillin is a type of Penicillins
Penicillins belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) and play a crucial role in the treatment of various bacterial infections. They are a class of antibiotics derived from the fungus Penicillium, and are widely used in the pharmaceutical industry.
Penicillins exert their antibacterial effect by inhibiting the formation of bacterial cell walls. They target a specific enzyme, called transpeptidase, which is responsible for cross-linking the peptidoglycan chains in the bacterial cell wall. By blocking this process, penicillins weaken the cell wall, leading to its rupture and subsequent bacterial death.
These APIs are classified into several subclasses, such as penicillin G, penicillin V, and extended-spectrum penicillins. Each subclass has unique characteristics and mechanisms of action. Penicillin G, for example, is effective against a broad range of Gram-positive bacteria, while penicillin V is primarily used for oral administration.
The pharmaceutical industry produces penicillins through a fermentation process using Penicillium strains. The obtained penicillin products are then isolated, purified, and formulated into different dosage forms, including tablets, capsules, and injectables.
Penicillins have been instrumental in the treatment of various infections, including respiratory, skin, urinary tract, and sexually transmitted infections. However, it's essential to note that some bacteria have developed resistance to penicillins through different mechanisms, such as the production of beta-lactamases. As a result, pharmaceutical companies have developed combination therapies and modified penicillins to combat antibiotic resistance effectively.
In summary, penicillins are a vital subcategory of pharmaceutical APIs that provide effective treatment options for bacterial infections. Their diverse subclasses, mechanisms of action, and formulations contribute to their widespread use in the medical field.
Amoxicillin (Penicillins), 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.
Amoxicillin API manufacturers & distributors
Compare qualified Amoxicillin API suppliers worldwide. We currently have 22 companies offering Amoxicillin API, with manufacturing taking place in 9 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 | 36 products |
| Antibióticos De León | Producer | Spain | Spain | CEP, CoA, FDA, GMP, USDMF | 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 |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, WC | 250 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS | 252 products |
| CSPC Zhongnuo | Producer | China | China | CEP, CoA, FDA, KDMF, USDMF | 6 products |
| Daewoong Bio | Producer | South Korea | South Korea | CoA, JDMF | 12 products |
| Fersinsa Gb | Producer | Mexico | Mexico | CEP, CoA, FDA | 2 products |
| Glaxosmithkline | Producer | United Kingdom | United Kingdom | CEP, CoA, GMP, USDMF | 19 products |
| Indukern Chemie AG | Distributor | Switzerland | Unknown | CoA | 13 products |
| Inner Mongolia Changsheng | Producer | China | China | CEP, CoA, KDMF | 2 products |
| Istituto Biochimico Itali... | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 5 products |
| N.C. Pharma Group | Producer | China | China | CEP, CoA, GMP | 1 products |
| Sandoz | Producer | Austria | Unknown | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 58 products |
| Shandong N.T. Pharma | Producer | China | China | CoA, WC | 12 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, KDMF, MSDS, USDMF | 764 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP | 219 products |
| The United Laboratories | Producer | China | China | CEP, CoA, FDA, GMP, WC | 1 products |
| United Pharma Industries ... | Distributor | China | China | CoA | 12 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 146 products |
| Zhuhai United Labs | Producer | China | China | CEP, CoA, GMP, KDMF, USDMF, WC | 12 products |
When sending a request, specify which Amoxicillin 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 Amoxicillin 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 Amoxicillin API
Sourcing
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Technical
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Regulatory
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