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Gatifloxacin | CAS No: 112811-59-3 | GMP-certified suppliers
A medication that treats bacterial respiratory conditions such as bronchitis, sinusitis, and community‑acquired pneumonia, as well as selected skin and soft tissue infections.
Therapeutic categories
Primary indications
- For the treatment of bronchitis, sinusitis, community-acquired pneumonia, and skin infections (abscesses, wounds) caused by S
- Pneumoniae, H
- Influenzae, S
- Aureus, M
Product Snapshot
- Gatifloxacin is available as oral small‑molecule tablets, intravenous solutions, and ophthalmic or topical drops
- It is used for bacterial respiratory tract and skin infection indications addressed by susceptible organisms
- It has a history of approvals in the US and Canada with status varying by formulation between approved, withdrawn, and investigational
Clinical Overview
Gatifloxacin exerts bactericidal activity through high‑affinity inhibition of bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination. The molecule demonstrates broad‑spectrum activity against Gram‑positive and Gram‑negative pathogens, with substantially greater affinity for bacterial targets than for mammalian enzymes.
Systemic gatifloxacin was available as oral tablets and intravenous aqueous solutions, and the compound displays pharmacokinetic properties typical of fluoroquinolones, with adequate systemic exposure following oral administration. Ophthalmic solutions provide high local concentrations with minimal systemic absorption.
Safety considerations have been central to its regulatory history. Reports of significant dysglycemia, including both hypoglycemia and hyperglycemia, led to the withdrawal of non‑ophthalmic formulations in the United States. As with other fluoroquinolones, additional concerns include potential QT interval prolongation and rare but serious central nervous system or tendon‑related adverse effects. The ophthalmic formulation presents a different systemic exposure profile, reducing but not eliminating the need for risk evaluation in vulnerable populations.
Common usage contexts today focus on ophthalmic therapy where approved. Systemic use persists only in certain jurisdictions or research settings and should follow local regulatory guidance and antimicrobial stewardship principles.
For API procurement, sourcing should prioritize suppliers with validated fluoroquinolone manufacturing processes, stringent impurity controls, and documentation aligned with relevant pharmacopeial and regulatory expectations, especially given the compound’s historical safety‑related scrutiny.
Identification & chemistry
| Generic name | Gatifloxacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 112811-59-3 |
| UNII | 81485Y3A9A |
| DrugBank ID | DB01044 |
Pharmacology
| Summary | Gatifloxacin is a synthetic fluoroquinolone that exerts bactericidal activity by inhibiting bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, enzymes essential for DNA replication and repair. Its pharmacologic effect stems from high-affinity binding to these targets, leading to disruption of DNA topology and blockage of bacterial cell division. The drug demonstrates broad-spectrum activity against key Gram-positive and Gram‑negative respiratory and skin pathogens. |
|---|---|
| Mechanism of action | The bactericidal action of Gatifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. |
| Pharmacodynamics | Gatifloxacin is a synthetic broad-spectrum 8-methoxyfluoroquinolone antibacterial agent for oral or intravenous administration. is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Gatifloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. It should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA gyrase subunit A | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | inhibitor |
| DNA gyrase subunit B | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | inhibitor |
| DNA topoisomerase 4 subunit A | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | inhibitor |
ADME / PK
| Absorption | Well absorbed from the gastrointestinal tract after oral administration with absolute bioavailability of gatifloxacin is 96% |
|---|---|
| Half-life | 7-14 hours |
| Protein binding | 20% |
| Metabolism | Gatifloxacin undergoes limited biotransformation in humans with less than 1% of the dose excreted in the urine as ethylenediamine and methylethylenediamine metabolites |
Formulation & handling
- Suitable for aqueous ophthalmic and IV solutions due to high polarity and moderate water solubility, but requires pH control to maintain clarity and chemical stability.
- Oral tablet formulations are feasible for this small molecule, as absorption is not affected by food and permeability is adequate for systemic exposure.
- Photolability and hydrolytic sensitivity typical of fluoroquinolones warrant protection from strong light and careful control of solution pH during manufacturing and storage.
Regulatory status
| Lifecycle | The API’s key U.S. and Canadian patents expired between 2009 and 2020, indicating that major exclusivities have lapsed. With products marketed in both the United States and Canada, the asset sits in a mature, post‑exclusivity phase. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Gatifloxacin has multiple packagers and was originally developed by a small number of innovator firms, with subsequent distribution by several repackagers and secondary suppliers. Branded and generic products are present mainly in the US and Canada, indicating a limited but established global footprint. Key US and Canadian patents have expired between 2009 and 2020, supporting the presence of existing generic competition in these markets. |
|---|
Written Confirmation
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document set up by the health authorities of the country where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to regularly take place in the future.
Gatifloxacin is a type of 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.
Gatifloxacin API manufacturers & distributors
Compare qualified Gatifloxacin API suppliers worldwide. We currently have 7 companies offering Gatifloxacin API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Jiangxi Chenyang | Producer | China | China | CoA | 5 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
When sending a request, specify which Gatifloxacin 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 Gatifloxacin 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 Gatifloxacin API
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Technical
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Regulatory
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Pharmaoffer
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