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Norfloxacin | CAS No: 70458-96-7 | GMP-certified suppliers
A medication that treats urinary tract infections and supports reliable antibacterial coverage, offering sourcing managers a consistent option for formulations targeting common uropathogens.
Therapeutic categories
Primary indications
- For the treatment of urinary tract infection
Product Snapshot
- Norfloxacin is an oral and ophthalmic small‑molecule API available in multiple solid and liquid formulations
- It is primarily used for pharmaceutical products targeting urinary tract infection
- It is approved in the US and Canada for commercial use
Clinical Overview
The pharmacodynamic profile is characterized by targeted inhibition of bacterial DNA synthesis. Norfloxacin binds with high affinity to topoisomerase II (DNA gyrase) and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination. Its affinity for bacterial gyrase is substantially higher than for mammalian isoenzymes, contributing to selective antibacterial activity. The fluorine atom at position 6 enhances potency against Gram‑negative organisms, while the piperazine moiety at position 7 supports activity against Pseudomonas species.
Absorption after oral administration is moderate, and systemic exposure is lower than that of later‑generation fluoroquinolones. Distribution is greatest in renal and urinary tissues, consistent with its clinical indication. Norfloxacin undergoes limited metabolism, and most of the administered dose is excreted unchanged in urine. Clearance is primarily renal, and reduced renal function can increase systemic levels.
Safety considerations align with the fluoroquinolone class. Reported risks include tendinopathy, potential QTc interval prolongation, central nervous system effects, and photosensitivity. Caution is warranted in individuals with known risk factors for arrhythmia or tendon disorders. Norfloxacin has documented inhibitory effects on CYP1A2 and multiple CYP3A isoforms, which may influence the disposition of coadministered substrates. It is also an inhibitor of renal transporter OAT1. Toxicity increases with excessive systemic exposure, underscoring the importance of dose adjustment in renal impairment.
Norfloxacin is available in various regional brands for systemic and ophthalmic use.
For API procurement, suppliers should provide full characterization data, impurity profiles aligned with pharmacopeial expectations, and evidence of controlled residual solvent levels. Manufacturing under a robust quality system and traceability of starting materials are critical for regulatory compliance and formulation suitability.
Identification & chemistry
| Generic name | Norfloxacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 70458-96-7 |
| UNII | N0F8P22L1P |
| DrugBank ID | DB01059 |
Pharmacology
| Summary | Norfloxacin is a fluoroquinolone antibiotic that exerts bactericidal activity by inhibiting bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, enzymes essential for DNA replication and repair. Its selectivity reflects substantially higher affinity for bacterial targets than for mammalian counterparts. Structural features such as the 6‑fluorine and 7‑piperazine groups enhance activity against gram‑negative organisms, including Pseudomonas species. |
|---|---|
| Mechanism of action | The bactericidal action of Norfloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. Norfloxacin is a broad-spectrum antibiotic agent that is shown to be effective against various Gram-positive and Gram-negative bacterial species. The fluorine atom at the 6 position increases potency against gram-negative organisms, and the piperazine moiety at the 7 position is responsible for anti-pseudomonal activity |
| Pharmacodynamics | Norfloxacin is a quinolone/fluoroquinolone antibiotic. Norfloxacin 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. |
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 | Rapid |
|---|---|
| Half-life | 3-4 hours |
| Protein binding | 10 and 15% (Serum protein binding) |
| Metabolism | Via liver and kidney |
| Route of elimination | Norfloxacin is eliminated through metabolism, biliary excretion, and renal excretion. It is expected to undergo both glomerular filtration and tubular secretion during renal excretion, as shown by its high renal clearance rate of approximately 275 mL/min. |
Formulation & handling
- Oral formulations require consideration of modest aqueous solubility and reduced absorption with food, favoring designs that limit food effects.
- As a small-molecule quinolone, it is stable in solid state but sensitive to chelation, so avoid formulation components containing multivalent cations.
- Ophthalmic solutions and ointments require attention to solubility, pH control, and particulate limits to maintain clarity and ocular tolerability.
Regulatory status
| Lifecycle | The API is marketed in Canada and the US, where patent protection has either expired or is approaching expiry, indicating a transition toward a mature, generics‑driven market. As exclusivity concludes, competition is expected to stabilize pricing and broaden manufacturer participation. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The supply landscape for norfloxacin includes several originator or early‑market manufacturers, with multiple secondary packagers supporting distribution. Branded products have a presence in the US and Canada, indicating a mature global footprint limited mainly to North American markets. Patent expiry for this fluoroquinolone is long past, so generic competition is well established. |
|---|
Norfloxacin 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.
Norfloxacin (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.
Norfloxacin API manufacturers & distributors
Compare qualified Norfloxacin API suppliers worldwide. We currently have 12 companies offering Norfloxacin API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Chr. Olesen Group | Distributor | Denmark | China | CoA, USDMF | 252 products |
| Cipla | Producer | India | India | CoA, GMP, USDMF, WC | 164 products |
| KRKA | Producer | Slovenia | Unknown | CEP, CoA, GMP | 81 products |
| Kyowa Pharma Chem. | Producer | Japan | Unknown | CoA, JDMF | 12 products |
| Nakoda Chemicals | Producer | India | India | CoA, FDA, WC | 6 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, USDMF, WC | 757 products |
| Zhejiang Lepu | Producer | China | China | CoA, WC | 2 products |
| Zhejiang Neo-Dankong | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, WC | 8 products |
When sending a request, specify which Norfloxacin 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 Norfloxacin 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 Norfloxacin API
Sourcing
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Technical
What is Norfloxacin (CAS 70458-96-7) used for?
Which therapeutic class does Norfloxacin fall into?
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How does Norfloxacin work?
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What are important formulation and handling considerations for Norfloxacin as an API?
Is Norfloxacin a small molecule?
Are there special stability concerns for oral Norfloxacin?
Regulatory
Where is Norfloxacin approved or in use globally?
Pharmaoffer
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