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Erythromycin | CAS No: 114-07-8 | GMP-certified suppliers
A medication that treats a broad range of respiratory, skin, gastrointestinal, and select sexually transmitted infections caused by susceptible organisms for reliable clinical management needs.
Therapeutic categories
Primary indications
- Erythromycin is indicated in the treatment of infections caused by susceptible strains of various bacteria
- The indications for erythromycin have been summarized by body system below:
- Respiratory infections**
- Mild to moderate upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with appropriate doses of sulfonamides) can be treated with erythromycin
Product Snapshot
- This macrolide antibiotic is available as oral solid and liquid forms, injectable solutions, and multiple topical formulations
- It is used for a broad range of infections caused by susceptible bacteria, including respiratory, skin, gastrointestinal, and select genital pathogens
- It is approved in the United States and Canada, with additional investigational and veterinary statuses noted
Clinical Overview
Erythromycin is indicated for mild to moderate respiratory tract infections due to Streptococcus pyogenes, Streptococcus pneumoniae, Bordetella pertussis, Mycoplasma pneumoniae, Listeria monocytogenes, and Corynebacterium diphtheriae, including eradication of carrier states when used with antitoxin. It is used as an alternative agent for prevention of rheumatic fever in penicillin-intolerant patients. Skin and soft tissue infections caused by susceptible streptococci and staphylococci, including erythrasma, may also be treated. Additional uses include intestinal amebiasis, selected sexually transmitted infections such as primary syphilis in penicillin‑allergic patients, chlamydial infections in pregnancy, neonatal conjunctivitis, pneumonia of infancy, and nongonococcal urethritis due to Ureaplasma urealyticum.
Erythromycin inhibits bacterial protein synthesis by binding to 23S rRNA within the 50S ribosomal subunit, blocking transpeptidation and translocation steps and preventing assembly of the functional ribosome. Its pharmacodynamic effect is primarily bacteriostatic, with activity dependent on achieving adequate tissue concentrations in relation to organism susceptibility.
Absorption after oral administration is variable due to acid lability but improves with certain formulations. The drug is widely distributed, undergoes hepatic metabolism primarily via CYP3A pathways, and is excreted mainly in bile. It is a substrate and inhibitor of CYP3A and several transporters including P‑glycoprotein and OATP1B1/1B3, creating potential for clinically relevant drug interactions.
Adverse effects include gastrointestinal intolerance, hepatotoxicity including cholestatic jaundice, and rare pseudomembranous colitis. QT interval prolongation has been reported, particularly with interacting agents.
For API procurement, manufacturers should verify strain source, control polymorphic form, and ensure compliance with pharmacopeial standards, microbial limits, and residual solvent specifications to support reliable formulation performance and regulatory acceptance.
Identification & chemistry
| Generic name | Erythromycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 114-07-8 |
| UNII | 63937KV33D |
| DrugBank ID | DB00199 |
Pharmacology
| Summary | Erythromycin is a macrolide antibacterial that inhibits bacterial protein synthesis by binding to the 23S rRNA within the 50S ribosomal subunit, blocking translocation and subunit assembly. This action suppresses bacterial growth across a range of susceptible organisms without affecting nucleic acid synthesis. Additional interactions with the motilin receptor and hERG channels contribute to secondary pharmacologic effects. |
|---|---|
| Mechanism of action | In order to replicate, bacteria require a specific process of protein synthesis, enabled by ribosomal proteins.Erythromycin acts by inhibition of protein synthesis by binding to the 23S ribosomal RNA molecule in the 50S subunit of ribosomes in susceptible bacterial organisms. It stops bacterial protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit.This results in the control of various bacterial infections.The strong affinity of macrolides, including erythromycin, for bacterial ribosomes, supports their broad‐spectrum antibacterial activities. |
| Pharmacodynamics | Macrolides, such as erythromycin, stop bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections.Erythromycin does not exert effects on nucleic acid synthesis.This drug has been shown to be active against most strains of the following microorganisms, effectively treating both in vitro and clinical infections. Despite this, it is important to perform bacterial susceptibility testing before administering this antibiotic, as resistance is a common issue that may affect treatment. **A note on antimicrobial resistance, pseudomembranous colitis, and hepatotoxicity** Many strains of Haemophilus influenzae are resistant to erythromycin alone but are found to be susceptible to erythromycin and sulfonamides used in combination. It is important to note that Staphylococci that are resistant to erythromycin may emerge during erythromycin and/or sulfonamide therapy.Pseudomembranous colitis has been reported with most antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, the physician should consider this diagnosis in patients with diarrhea after the administration of antibacterial agents.Erythromycin can cause hepatic dysfunction, cholestatic jaundice, and abnormal liver transaminases, particularly when erythromycin estolate is administered. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 23S ribosomal RNA | Enteric bacteria and other eubacteria | inhibitor |
| Motilin receptor | Humans | agonist |
| Potassium voltage-gated channel subfamily H member 2 | Humans | inhibitor |
ADME / PK
| Absorption | Orally administered erythromycin is readily absorbed. Food intake does not appear to exert effects on serum concentrations of erythromycin.Some interindividual variation exists in terms of erythromycin absorption, which may impact absorption to varying degrees.The Cmax of erythromycin is 1.8 mcg/Land the Tmax is 1.2 hours.The serum AUC of erythromycin after the administration of a 500mg oral dose was 7.3±3.9 mg.h/l in one pharmacokinetic study.Erythromycin is well known for a bioavailability that is variable (18-45%) after oral administration and its susceptibility to broken down under acidic conditions. |
|---|---|
| Half-life | The elimination half-life of oral erythromycin was 3.5 hours according to one studyand ranged between 2.4-3.1 hours in another study.Repetitive dosing of erythromycin leads to increased elimination half-life. |
| Protein binding | Erythromycin demonstrates 93% serum protein binding in the erythromycin propionate form.Another resource indicates that erythromycin protein binding ranges from 80 to 90%. |
| Metabolism | Hepatic first-pass metabolism contributes significantly to erythromycin metabolism after an oral dose.Erythromycin is partially metabolized by CYP3A4 enzyme to N-desmethylerythromycin.Erythromycin is also hydrolyzed to _anhydro_ forms (anhydroerythromycin [AHE] and other metabolites), and this process is promoted by acidic conditions.AHE is inactive against microbes but inhibits hepatic drug oxidation and is therefore considered to be an important contributor to erythromycin drug-drug interactions. |
| Route of elimination | In patients with normal liver function, erythromycin concentrates in the liver and is then excreted in the bile.Under 5% of the orally administered dose of erythromycin is found excreted in the urine.A high percentage of absorbed erythromycin is not accounted for, but is likely metabolized. |
| Volume of distribution | Erythromycin is found in most body fluids and accumulates in leucocytes and inflammatory liquid.Spinal fluid concentrations of erythromycin are low, however, the diffusion of erythromycin through the blood-brain barrier increases in meningitis, likely due to the presence of inflamed tissues which are easily penetrated.Erythromycin crosses the placenta. |
| Clearance | The clearance of erythromycin in healthy subjects was 0.53 ± 0.13 l/h/kg after a 125mg intravenous dose.In a clinical study of healthy patients and patients with liver cirrhosis, clearance of erythromycin was significantly reduced in those with severe liver cirrhosis.The clearance in cirrhotic patients was 42.2 ± 10.1 l h–1 versus 113.2 ± 44.2 l h-1 in healthy patients. |
Formulation & handling
- Oral formulations typically require enteric‑coated or delayed‑release systems due to acid lability and modest aqueous solubility.
- Food reduces absorption, so formulations may need to consider administration on an empty stomach and avoidance of grapefruit components.
- Parenteral presentations require reconstitution of lyophilized powder and protection from acidic conditions to maintain stability.
Regulatory status
| Lifecycle | The API is marketed in the US and Canada, where patent expiry timing indicates that the product is in a mature phase with established generic participation or near‑term loss of exclusivity. Market dynamics are expected to remain stable as competition aligns with typical post‑patent conditions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Erythromycin has multiple historical originators, with early development led by large multinational pharmaceutical firms and subsequent manufacturing taken up by numerous branded and generic producers. Branded and legacy products remain present in the US and Canada, and the molecule has long-established global use in other regions. Patent expiry occurred decades ago, so the market is characterized by mature, broad generic competition across both finished‑dose and API supply. |
|---|
Safety
| Toxicity | LD50 The oral LD50 of erythromycin in rats is 9272 mg/kg. Overdose information Symptoms of overdose may include diarrhea, nausea, stomach cramps, and vomiting. Erythromycin should immediately be discontinued in cases of overdose. Rapid elimination of unabsorbed drug should be attempted. Supportive measures should be initiated. Erythromycin is not adequately removed by peritoneal dialysis or hemodialysis. |
|---|
- Oral LD50 in rats is 9272 mg/kg, indicating relatively low acute lethality but warranting standard controls to limit high‑dose exposure
- Overexposure is associated with gastrointestinal irritation manifested by nausea, vomiting, diarrhea, and abdominal cramping
- The compound is not effectively cleared by hemodialysis or peritoneal dialysis, underscoring the need for conventional industrial hygiene measures to prevent significant ingestion
Erythromycin is a type of Macrolides
Macrolides are a significant subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the healthcare industry. These compounds belong to a class of antibiotics characterized by a large macrocyclic lactone ring, which is the key structural feature responsible for their therapeutic activity.
Macrolides possess a broad spectrum of activity against various bacteria, making them valuable in the treatment of many bacterial infections. They work by inhibiting the synthesis of bacterial proteins, thereby preventing their growth and replication. This mechanism of action makes macrolides effective against both Gram-positive and some Gram-negative bacteria.
One of the most well-known macrolide antibiotics is erythromycin, which has been used for decades to treat respiratory tract infections, skin infections, and sexually transmitted diseases. Over time, several derivatives and semi-synthetic macrolides have been developed, such as azithromycin and clarithromycin, which offer improved pharmacokinetic properties, increased efficacy, and broader spectrum of activity.
Macrolides are often preferred in clinical practice due to their favorable pharmacokinetics, including high tissue penetration, prolonged half-life, and low toxicity. They are commonly prescribed for patients who are allergic to penicillin or have other contraindications to beta-lactam antibiotics.
In conclusion, macrolides represent a vital subclass of pharmaceutical APIs with potent antibacterial properties. Their broad spectrum of activity, favorable pharmacokinetic profile, and versatility make them indispensable in the treatment of various bacterial infections.
Erythromycin (Macrolides), 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.
Erythromycin API manufacturers & distributors
Compare qualified Erythromycin API suppliers worldwide. We currently have 21 companies offering Erythromycin 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 |
|---|---|---|---|---|---|
| Abbvie | Producer | United States | United States | CEP, CoA, FDA, GMP, USDMF | 11 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CoA, GMP, MSDS | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS | 250 products |
| Biovet AD | Producer | Bulgaria | Bulgaria | CoA, JDMF | 2 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cambrex | Producer | Italy | Unknown | CoA, JDMF | 104 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO14001, ISO9001, MSDS | 235 products |
| Chifeng Arker Tech. | Producer | China | China | CoA, WC | 8 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Malaysia | CoA, GMP, ISO9001, MSDS | 170 products |
| Envee Drugs Pvt Ltd | Producer | India | India | CoA, GMP, ISO9001 | 16 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| HEC Pharm | Producer | Germany | China | CEP, CoA, FDA, GMP, JDMF, USDMF | 31 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| SM Biomed | Producer | Malaysia | Malaysia | CEP, CoA, GMP, USDMF | 3 products |
| Socosur | Distributor | France | Unknown | CoA | 21 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 133 products |
| Xi’an Lijun Pharma | Producer | China | China | CoA, USDMF | 2 products |
When sending a request, specify which Erythromycin 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 Erythromycin 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 Erythromycin API
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Technical
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Regulatory
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