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Azithromycin | CAS No: 83905-01-5 | GMP-certified suppliers
A medication that treats a range of respiratory, skin, and genitourinary bacterial infections in adults and children when caused by susceptible pathogens.
Therapeutic categories
Primary indications
- Azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria in order to prevent the development antimicrobial resistance and maintain the efficacy of azithromycin [FDA label]
- Azithromycin is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the microorganisms listed in the specific conditions below
- Recommended dosages, duration of therapy and considerations for various patient populations may vary among these infections
- Refer to the FDA label and "Indications" section of this drug entry for detailed information [FDA label]
Product Snapshot
- Azithromycin is an oral and intravenous small‑molecule macrolide antibiotic available in multiple solid and liquid formulations
- It is used for a broad range of bacterial respiratory, dermatologic, and genitourinary infections caused by susceptible organisms
- It is approved in the US and Canada with established regulatory status across these markets
Clinical Overview
Its clinical use includes mild to moderate respiratory, enteric, and genitourinary infections in adults, such as acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community‑acquired pneumonia, pharyngitis or tonsillitis in patients unable to take first‑line agents, uncomplicated skin and soft tissue infections, urethritis or cervicitis due to susceptible pathogens, and chancroid in men. In pediatric patients, it is used for acute otitis media, community‑acquired pneumonia, and pharyngitis or tonsillitis when alternative therapy is needed.
Azithromycin exerts bacteriostatic activity through high‑affinity binding to the 23S rRNA of the 50S ribosomal subunit, inhibiting the transpeptidation and translocation steps of protein synthesis and preventing assembly of the functional ribosomal complex. Additional immunomodulatory effects have been described, supporting its use in certain chronic respiratory inflammatory conditions.
After oral administration, azithromycin demonstrates high tissue penetration, extensive distribution, and prolonged tissue residence, contributing to a long terminal half‑life. It is stable in acidic environments and is variably metabolized, with a portion excreted unchanged. It is a substrate and inhibitor of CYP3A4 and P‑glycoprotein, creating potential for drug–drug interactions.
Safety considerations include gastrointestinal intolerance, hepatotoxicity, hypersensitivity reactions, and QT interval prolongation with rare arrhythmia risk. Use in patients with known macrolide hypersensitivity or significant cardiac conditions requires caution. Macrolide resistance should be considered when interpreting local susceptibility patterns.
Common brand names include Zithromax and other regionally licensed products.
For API procurement, suppliers should provide validated impurity profiles, demonstrated control of stereochemistry, and evidence of GMP‑aligned manufacturing to ensure consistent quality for formulation and regulatory submissions.
Identification & chemistry
| Generic name | Azithromycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 83905-01-5 |
| UNII | J2KLZ20U1M |
| DrugBank ID | DB00207 |
Pharmacology
| Summary | Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to 23S rRNA within the 50S ribosomal subunit, blocking transpeptidation and translocation steps. This action suppresses growth of susceptible bacteria and contributes to its broad‑spectrum activity; the drug also demonstrates immunomodulatory effects relevant to chronic inflammatory airway diseases. Primary targets include bacterial 23S rRNA and, to a lesser extent, protein‑arginine deiminase type‑4. |
|---|---|
| Mechanism of action | In order to replicate, bacteria require a specific process of protein synthesis, enabled by ribosomal proteins . Azithromycin binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It stops bacterial protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit [FDA label], . This results in the control of various bacterial infections , [FDA label]. The strong affinity of macrolides, including azithromycin, for bacterial ribosomes, is consistent with their broad‐spectrum antibacterial activities . Azithromycin is highly stable at a low pH, giving it a longer serum half-life and increasing its concentrations in tissues compared to erythromycin . |
| Pharmacodynamics | Macrolides stop bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections . Azithromycin has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose . |
Targets
| Target | Organism | Actions |
|---|---|---|
| 23S ribosomal RNA | Enteric bacteria and other eubacteria | inhibitor |
| Protein-arginine deiminase type-4 | Humans | inhibitor |
ADME / PK
| Absorption | Bioavailability of azithromycin is 37% following oral administration. Absorption is not affected by food. Macrolide absorption in the intestines is believed to be mediated by P-glycoprotein (ABCB1) efflux transporters, which are known to be encoded by the _ABCB1_ gene . |
|---|---|
| Half-life | Terminal elimination half-life: 68 hours [FDA label] |
| Protein binding | The serum protein binding of azithromycin varies in humans, decreasing from 51% at 0.02 g/mL to 7% at 2 g/mL [FDA label]. |
| Metabolism | In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed [FDA label], however, this drug is eliminated by the liver , [FDA label]. |
| Route of elimination | Biliary excretion of azithromycin, primarily as unchanged drug, is a major route of elimination. Over a 1 week period, approximately 6% of the administered dose is found as unchanged drug in urine [FDA label]. |
| Volume of distribution | After oral administration, azithromycin is widely distributed in tissues with an apparent steady-state volume of distribution of 31.1 L/kg [FDA label]. Significantly greater azithromycin concentrations have been measured in the tissues rather than in plasma or serum [FDA label], . The lung, tonsils and prostate are organs have shown a particularly high rate of azithromycin uptake . This drug is concentrated within macrophages and polymorphonucleocytes, allowing for effective activity against Chlamydia trachomatis . In addition, azithromycin is found to be concentrated in phagocytes and fibroblasts, shown by in vitro incubation techniques. In vivo studies demonstrate that concentration in phagocytes may contribute to azithromycin distribution to inflamed tissues [FDA label]. |
| Clearance | Mean apparent plasma cl=630 mL/min (following single 500 mg oral and i.v. dose) [FDA label] |
Formulation & handling
- Oral formulations should account for modest aqueous solubility and recommended empty‑stomach administration, with suspension products requiring uniform reconstitution.
- IV products are typically supplied as lyophilized powder requiring controlled reconstitution and dilution to maintain stability and avoid precipitation.
- Ophthalmic solutions require attention to solution clarity and pH/osmolality control to ensure chemical stability and ocular tolerability.
Regulatory status
| Lifecycle | Most U.S. protection has lapsed, with one patent expiring in 2010 and others ending in early 2024, while the remaining Canadian patent expired in 2024, indicating that both the U.S. and Canadian markets are now in a mature, post‑exclusivity phase. As a result, the API is positioned for broad generic competition across both markets. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Azithromycin was originally developed and commercialized by a small group of originator companies, with subsequent large-scale manufacturing now carried out by numerous generic producers across the US, Canada, and other global markets. Branded products remain available in North America, but the compound is widely established internationally in both branded and generic forms. Key US and Canadian patents have expired or are expiring, indicating long‑standing and ongoing generic competition. |
|---|
Safety
| Toxicity | **Rat Oral LD50**: >2000 mk/kg [MSDS] Possible major adverse effects include cardiovascular arrhythmias and hearing loss. Macrolide resistance is also an ongoing issue.Hepatotoxicity has been observed in rare cases. **A note on the risk of liver toxicity**: Due to the act that azithromycin is mainly eliminated by the liver, caution should be observed when azithromycin is given to patients with decreased hepatic function [FDA label]. **A note on potential renal toxicity**: Because limited data in patients with renal GFR <10 mL/min, caution should be exercised when prescribing azithromycin to these patients [FDA label]. **Use in Pregnancy**: This drug is categorized as a pregnancy category B drug. Reproduction studies have been done in rats and mice at doses up to moderately maternally toxic doses (for example, 200 mg/kg/day). These doses, based on a mg/m2 basis, are approximately 4 and 2 times, respectively, the human daily dose of 500 mg. In the animal studies, no harmful effects to the fetus due to azithromycin were observed. There are, at this time, no conclusive and well-controlled studies that have been done in pregnant women. Because animal reproduction studies do not always predict human response, azithromycin should be used during pregnancy only if clearly needed [FDA label]. **Nursing Mothers**: It is unknown at this time whether azithromycin is excreted in human milk. Because many other drugs are excreted in human milk, caution should be observed when azithromycin is given to a nursing woman [FDA label]. **Carcinogenesis, Mutagenesis, Impairment of Fertility**: Long-term studies in animals have not been performed to study carcinogenic potential. Azithromycin has demonstrated no potential to be mutagenic in standard laboratory tests. No evidence of negative effects on fertility due to azithromycin was found [FDA label]. |
|---|
- Rat oral LD50 ›2000 mg/kg indicates low acute oral toxicity, but material should be handled to avoid inhalation or high‑dose exposure
- Reported adverse effects include cardiovascular arrhythmias, ototoxicity, and rare hepatotoxicity
- Monitor for conditions that may impact safe manufacturing or containment
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Azithromycin 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.
Azithromycin (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.
Azithromycin API manufacturers & distributors
Compare qualified Azithromycin API suppliers worldwide. We currently have 24 companies offering Azithromycin API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| 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, GMP, ISO9001, MSDS | 250 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| CSPC Ouyi Pharma | Producer | China | China | CEP, CoA, FDA, USDMF | 3 products |
| Duke Chem | Producer | Spain | Spain | CoA, GMP | 8 products |
| Envee Drugs Pvt Ltd | Producer | India | India | CoA, GMP, ISO9001 | 16 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| G.C. Chemie Pharmie Ltd | Producer | India | India | CoA | 21 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, KDMF, MSDS, USDMF | 484 products |
| HEC Pharm | Producer | Germany | China | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 31 products |
| Kopran R.L. | Producer | India | India | CEP, CoA, FDA, GMP, WC | 8 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 155 products |
| PLIVA | Producer | Czech Republic | Czech Republic | CEP, CoA, GMP | 31 products |
| Sandoz | Producer | Austria | Unknown | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 58 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 157 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
| Solfyn International LLP | Distributor | India | China | BSE/TSE, CoA, GMP, MSDS, USDMF, WHO-GMP | 24 products |
| Sterile India | Producer | India | India | CoA, ISO9001, USDMF, WHO-GMP | 13 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 144 products |
| Zhejiang Guobang | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, WC | 6 products |
When sending a request, specify which Azithromycin 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 Azithromycin 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 Azithromycin API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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