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Ofloxacin | CAS No: 82419-36-1 | GMP-certified suppliers
A medication that treats respiratory, urinary, kidney, skin, and soft‑tissue infections, as well as urethral and cervical gonorrhoea, supporting broad clinical infection management needs.
Therapeutic categories
Primary indications
- For the treatment of infections (respiratory tract, kidney, skin, soft tissue, UTI), urethral and cervical gonorrhoea
Product Snapshot
- Ofloxacin is available as an oral small‑molecule antibiotic and in multiple topical and injectable formulations, including ophthalmic and intravenous solutions
- It is used for bacterial infections involving the respiratory tract, urinary tract, skin and soft tissue, as well as urethral and cervical gonorrhoea
- It is approved in the US and Canada for these uses
Clinical Overview
Pharmacologically, ofloxacin is bactericidal. It exerts its effect through high‑affinity binding to bacterial DNA gyrase and topoisomerase IV. These enzymes regulate DNA supercoiling and are essential for replication and transcription. Inhibition of their activity blocks DNA strand separation and halts bacterial cell division. The drug displays markedly higher affinity for bacterial DNA gyrase than for mammalian topoisomerases, contributing to its selective antimicrobial activity.
Absorption following oral administration is generally efficient, with systemic exposure supported by good tissue penetration. Distribution into respiratory tissues, genitourinary structures, and skin contributes to its clinical utility. Ofloxacin is eliminated primarily through renal excretion, with clearance influenced by kidney function. Dose adjustments are typically required in renal impairment to limit accumulation. Metabolic interactions may occur due to cytochrome P450 1A2 inhibition, and ofloxacin is also characterized as a substrate or inhibitor of several transporter pathways, including BSEP and OAT1.
Safety considerations include the recognized class effects of fluoroquinolones. These may include risks of tendinopathy, neuromuscular effects, central nervous system reactions, and QT interval prolongation, particularly in susceptible patients or with interacting drugs. Ofloxacin is additionally associated with photosensitivity and gastrointestinal disturbances. Toxicity risk increases with impaired renal function due to reduced clearance.
Ofloxacin has been marketed in multiple systemic, ophthalmic, and otic formulations worldwide. Product availability varies by region and may include both single‑agent and combination presentations.
For API procurement, manufacturers should confirm compliance with regional pharmacopeial specifications, verify impurity controls aligned with fluoroquinolone class expectations, and ensure traceability and GMP‑conformant production to support regulatory submissions and finished‑product quality.
Identification & chemistry
| Generic name | Ofloxacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 82419-36-1 |
| UNII | A4P49JAZ9H |
| DrugBank ID | DB01165 |
Pharmacology
| Summary | Ofloxacin is a fluoroquinolone antibiotic that targets bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication and transcription. By inhibiting these enzymes, it disrupts DNA supercoiling and prevents normal bacterial cell division, producing bactericidal activity. It exhibits broad-spectrum activity against Gram‑positive and Gram‑negative organisms relevant to respiratory, urinary, and soft‑tissue infections. |
|---|---|
| Mechanism of action | Ofloxacin acts on DNA gyrase and toposiomerase IV, enzymes which, like human topoisomerase, prevents the excessive supercoiling of DNA during replication or transcription. By inhibiting their function, the drug thereby inhibits normal cell division. |
| Pharmacodynamics | Ofloxacin is a quinolone/fluoroquinolone antibiotic. Ofloxacin 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. Ofloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA gyrase subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | inhibitor |
| DNA topoisomerase 4 subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | inhibitor |
| DNA topoisomerase 2-alpha | Humans | inhibitor |
ADME / PK
| Absorption | Bioavailability of ofloxacin in the tablet formulation is approximately 98% |
|---|---|
| Half-life | 9 hours |
| Protein binding | 32% |
| Metabolism | Hepatic |
| Route of elimination | Ofloxacin is mainly eliminated by renal excretion, where between 65% and 80% of an administered oral dose of ofloxacin is excreted unchanged via urine within 48 hours of dosing. About 4-8% of an ofloxacin dose is excreted in the feces and the drug is minimally subject to biliary excretion. |
Formulation & handling
- Suitable for oral, ophthalmic, otic, and IV formulations; high aqueous solubility supports solution-based dosage forms across routes.
- Small-molecule quinolone with good chemical stability; standard light protection is typically sufficient for solutions.
- Oral absorption is not food‑dependent, simplifying tablet and capsule development and administration considerations.
Regulatory status
| Lifecycle | The active ingredient’s U.S. patent expired in 2012, indicating that it is in a mature stage of its lifecycle. With products marketed in the United States and Canada, the market is likely characterized by established generic availability and stable competition. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Ofloxacin was originally developed by a single originator, with subsequent manufacturing and distribution supported by a large number of packagers and generic firms. Branded products such as Floxin historically held presence in the US and Canada, but most market activity now consists of generics. The key US patent expired in 2012, indicating that generic competition is well‑established. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=5450 mg/kg (orally in mice) |
|---|
- Oral LD50 in mice of 5450 mg/kg indicates comparatively low acute toxicity, but standard controls for occupational exposure to β‑lactam/antibiotic sensitizers remain applicable
- Handle as a potential dermal and respiratory sensitizer
- Powdered material may provoke allergic reactions in previously exposed personnel
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)
Ofloxacin is a type of Quinolones
Quinolones belong to a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs). They are a group of synthetic antibiotics that possess a broad-spectrum activity against various bacterial infections. This technical description will shed light on the key characteristics and applications of quinolones.
Quinolones exhibit potent bactericidal activity by targeting DNA gyrase and topoisomerase IV, which are essential enzymes for bacterial DNA replication and repair. This mechanism of action distinguishes quinolones from other classes of antibiotics, making them effective against both Gram-positive and Gram-negative bacteria.
The versatility of quinolones enables their application in the treatment of a wide range of infections, including respiratory tract infections, urinary tract infections, gastrointestinal infections, skin and soft tissue infections, and sexually transmitted diseases. Furthermore, they have proven efficacy against bacteria resistant to other antibiotics, making them indispensable in clinical practice.
Pharmaceutical companies utilize advanced manufacturing processes to synthesize quinolones with high purity and quality. Stringent quality control measures ensure the safety and efficacy of these APIs, complying with regulatory standards.
Quinolones have revolutionized the field of antibacterial therapy, providing healthcare professionals with potent tools to combat bacterial infections. However, it is crucial to utilize them judiciously to prevent the emergence of antibiotic resistance.
In conclusion, quinolones, as a subcategory of pharmaceutical APIs, possess remarkable antibacterial properties, making them invaluable in the treatment of various infections. Their broad-spectrum activity, mechanism of action, and effectiveness against resistant bacteria make quinolones a crucial component of modern healthcare.
Ofloxacin (Quinolones), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Ofloxacin API manufacturers & distributors
Compare qualified Ofloxacin API suppliers worldwide. We currently have 16 companies offering Ofloxacin 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 |
|---|---|---|---|---|---|
| Alfresa Fine Chemical | Producer | Japan | Japan | CoA, JDMF | 2 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Daiichi Sankyo | Producer | Japan | Japan | CEP, CoA, FDA | 9 products |
| Ildong Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 4 products |
| Jiangxi Chenyang | Producer | China | China | CoA | 5 products |
| K. Sevantilal & Co. | Producer | India | India | CoA | 8 products |
| Quimdis | Distributor | France | Unknown | CoA | 17 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP, USDMF | 51 products |
| Ranbaxy Laboratories | Producer | India | India | CoA, JDMF | 7 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sun Pharma | Producer | India | India | CEP, CoA, WC | 219 products |
| TURTLE PHARMA | Producer | India | India | CoA, USDMF | 3 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Zhejiang East Asia Pharma... | Producer | China | China | CoA, JDMF | 4 products |
| Zhejiang East-Asia Pharma | Producer | China | China | CoA, JDMF | 7 products |
| Zhejiang Tiantai | Producer | China | China | CoA, WC | 7 products |
When sending a request, specify which Ofloxacin 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 Ofloxacin 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 Ofloxacin API
Sourcing
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Technical
What is Ofloxacin (CAS 82419-36-1) used for?
Which therapeutic class does Ofloxacin fall into?
What conditions is Ofloxacin mainly prescribed for?
How does Ofloxacin work?
What should someone know about the safety or toxicity profile of Ofloxacin?
What are important formulation and handling considerations for Ofloxacin as an API?
Is Ofloxacin a small molecule?
Are there special stability concerns for oral Ofloxacin?
Regulatory
Where is Ofloxacin approved or in use globally?
What’s the regulatory and patent landscape for Ofloxacin right now?
Pharmaoffer
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