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Fluconazole | CAS No: 86386-73-4 | GMP-certified suppliers
A medication that addresses systemic and mucosal Candida infections, cryptococcal meningitis, and high‑risk prophylaxis needs for partners sourcing reliable antifungal API supplies.
Therapeutic categories
14-alpha Demethylase InhibitorsAgents causing hyperkalemiaAnti-Infective AgentsAntifungal AgentsAntifungals for Dermatological UseAntifungals for Topical Use
Generic name
Fluconazole
Molecule type
small molecule
CAS number
86386-73-4
DrugBank ID
DB00196
Approval status
Approved drug, Investigational drug
ATC code
J01RA07
Primary indications
- Fluconazole can be administered in the treatment of the following fungal infections:
- Vaginal yeast infections caused by Candida
- Systemic Candida infections
- Both esophageal and oropharyngeal candidiasis
Product Snapshot
- Fluconazole is a small‑molecule antifungal available in oral, injectable, topical, and vaginal formulations
- It is used for a range of Candida infections and cryptococcal meningitis, including prophylactic use in high‑risk settings
- It is approved in the US and Canada, with both approved and investigational statuses noted across markets
Clinical Overview
Fluconazole (CAS 86386-73-4) is a triazole antifungal widely used for systemic and mucosal Candida infections and for cryptococcal meningitis. Clinical use spans vaginal candidiasis, esophageal and oropharyngeal candidiasis, candiduria, peritonitis caused by Candida species, and systemic candidemia. It is also used as prophylaxis in patients with bone marrow transplantation who are at high risk for invasive fungal disease. Initiation of therapy may occur before laboratory confirmation, but culture or serologic testing supports organism identification and susceptibility assessment.
Fluconazole exhibits fungistatic activity against susceptible strains of Candida albicans, Candida parapsilosis, Candida tropicalis, many strains of Candida glabrata with variable susceptibility, and Cryptococcus neoformans. Its activity relies on selective inhibition of fungal lanosterol 14‑alpha‑demethylase, a cytochrome P450–dependent enzyme required for conversion of lanosterol to ergosterol. Inhibition disrupts ergosterol biosynthesis, leading to accumulation of methylated sterols and impaired membrane integrity with arrest of fungal growth.
Absorption after oral administration is high, and systemic exposure correlates with dose. Distribution into cerebrospinal fluid is clinically relevant, supporting its role in cryptococcal meningitis. Metabolism is limited, and the compound is primarily eliminated unchanged in urine, making renal function an important determinant of clearance and dosing adjustments.
Resistance may result from altered target enzyme expression or function, decreased intracellular drug concentration, or other mechanisms under investigation. Given variable susceptibility among species, testing is recommended when managing refractory or recurrent infections.
Fluconazole is generally well tolerated, but hepatic enzyme elevations and rare severe hepatotoxicity have been reported. It inhibits several cytochrome P450 isoenzymes, creating potential for clinically significant drug interactions. QT prolongation risk should be considered in patients with predisposing conditions.
Marketed products include oral and intravenous formulations, with Diflucan as a well‑known brand. For API procurement, sourcing should prioritize manufacturers with robust impurity control, validated crystallization processes, and documentation supporting compliance with pharmacopeial and regional regulatory standards.
Fluconazole exhibits fungistatic activity against susceptible strains of Candida albicans, Candida parapsilosis, Candida tropicalis, many strains of Candida glabrata with variable susceptibility, and Cryptococcus neoformans. Its activity relies on selective inhibition of fungal lanosterol 14‑alpha‑demethylase, a cytochrome P450–dependent enzyme required for conversion of lanosterol to ergosterol. Inhibition disrupts ergosterol biosynthesis, leading to accumulation of methylated sterols and impaired membrane integrity with arrest of fungal growth.
Absorption after oral administration is high, and systemic exposure correlates with dose. Distribution into cerebrospinal fluid is clinically relevant, supporting its role in cryptococcal meningitis. Metabolism is limited, and the compound is primarily eliminated unchanged in urine, making renal function an important determinant of clearance and dosing adjustments.
Resistance may result from altered target enzyme expression or function, decreased intracellular drug concentration, or other mechanisms under investigation. Given variable susceptibility among species, testing is recommended when managing refractory or recurrent infections.
Fluconazole is generally well tolerated, but hepatic enzyme elevations and rare severe hepatotoxicity have been reported. It inhibits several cytochrome P450 isoenzymes, creating potential for clinically significant drug interactions. QT prolongation risk should be considered in patients with predisposing conditions.
Marketed products include oral and intravenous formulations, with Diflucan as a well‑known brand. For API procurement, sourcing should prioritize manufacturers with robust impurity control, validated crystallization processes, and documentation supporting compliance with pharmacopeial and regional regulatory standards.
Identification & chemistry
| Generic name | Fluconazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 86386-73-4 |
| UNII | 8VZV102JFY |
| DrugBank ID | DB00196 |
Pharmacology
| Summary | Fluconazole selectively inhibits the fungal cytochrome P450 enzyme lanosterol 14‑α‑demethylase, blocking conversion of lanosterol to ergosterol and disrupting membrane integrity. This results in fungistatic activity against susceptible Candida species and Cryptococcus neoformans. Resistance can emerge through alterations in the target enzyme or reduced intracellular access to the drug. |
|---|---|
| Mechanism of action | Fluconazole is a very selective inhibitor of fungal cytochrome P450 dependent enzyme _lanosterol 14-α-demethylase_. This enzyme normally works to convert _lanosterol_ to _ergosterol_, which is necessary for fungal cell wall synthesis. The free nitrogen atom located on the azole ring of fluconazole binds with a single iron atom located in the heme group of lanosterol 14-α-demethylase.This prevents oxygen activation and, as a result, inhibits the demethylation of lanosterol, halting the process of ergosterol biosynthesis.Methylated sterols are then found to accumulate in the fungal cellular membrane, leading to an arrest of fungal growth.These accumulated sterols negatively affect the structure and function of the fungal cell plasma membrane. Fluconazole resistance may arise from an alteration in the amount or function of the target enzyme (lanosterol 14-α-demethylase), altered access to this enzyme, or a combination of the above.Other mechanisms may also be implicated, and studies are ongoing. |
| Pharmacodynamics | Fluconazole has been demonstrated to show fungistatic activity against the majority of strains of the following microorganisms, curing fungal infections: _Candida albicans, Candida glabrata (Many strains are intermediately susceptible), Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans_ This is achieved through steroidal inhibition in fungal cells, interfering with cell wall synthesis and growth as well as cell adhesion, thereby treating fungal infections and their symptoms. The fungistatic activity of fluconazole has also been shown in normal and immunocompromised animal models with both systemic and intracranial fungal infections caused by _Cryptococcus neoformans_ and for systemic infections caused by Candida albicans.It is important to note that resistant organisms have been found against various strains of organisms treated with fluconazole.This further substantiates the need to perform susceptibility testing when fluconazole is considered as an antifungal therapy. **A note on steroidal effects of fluconazole** There has been some concern that fluconazole may interfere with and inactivate human steroids/hormones due to the inhibition of hepatic cytochrome enzymes.Fluconazole has demonstrated to be more selective for _fungal_ cytochrome P-450 enzymes than for a variety of mammalian cytochrome P-450 enzymes. Fluconazole 50 mg administered daily for up to 28 days in individuals of reproductive age has been show to have no effect on testosterone plasma concentrations of males and plasma concentrations of steroids in females. A 200-400 mg dose of fluconazole showed no clinically relevant effect on steroid levels or on ACTH-stimulated steroid response in healthy males, in one clinical study mentioned on the European Medicines Agency label.Other studies have shown no significant effects of fluconazole on steroid levels, further confirming these data. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 51 | Yeast | inhibitor |
ADME / PK
| Absorption | The pharmacokinetic properties of fluconazole are comparable after administration by the intravenous (IV) and oral (PO) routes. In healthy volunteers, the bioavailability of orally administered fluconazole is measured to be above 90%.It is extensively absorbed in the gastrointestinal tract when an oral dose is taken.Oral absorption is not affected by food intake with fluconazole but may increase the time until the maximum concentration is reached. Tmax (or the time taken to achieve the maximum concentration) in one clinical study of healthy patients receiving 50 mg/kg of fluconazole was 3 hours. Peak plasma concentrations (Cmax) in fasting and healthy volunteers occur between 1-2 hours post-dose.Steady-state concentrations are achieved within 5 to 10 days after oral doses of 50-400 mg administered once daily. Administration of a loading dose on the first day of fluconazole treatment, or twice the usual daily dose, leads to plasma concentrations close to steady-state by the second day.Mean AUC (area under the curve) was 20.3 in healthy volunteers receiving 25 mg of fluconazole. **A note on the capsule and powder form and malabsorption syndromes** The capsule forms of fluconazole often contain lactose and should not be administered with hereditary galactose intolerance, _Lapp lactase enzyme_ deficiency, or malabsorption of glucose/galactose.The powder form, used for the oral suspension, lists sucrose as an ingredient and should not be used in patients who have been diagnosed with fructose, glucose/galactose malabsorption, and _sucrase-isomaltase_ enzyme deficiency. |
|---|---|
| Half-life | The terminal elimination half-life in the plasma is approximately 30 hours (range: 20-50 hours) after oral administration.The long plasma elimination half-life supports a single-dose therapy for vaginal candidiasis, once daily and once weekly dosing for other indications.Patients with renal failure may require dosage adjustment, and half-life can be significantly increased in these patients. |
| Protein binding | The protein binding of fluconazole is low and estimated to be 11 to 12%. |
| Metabolism | Fluconazole is metabolized minimally in the liver. Fluconazole is an inhibitor of CYP2C9, CYP3A4 and CYP2C19.Two metabolites were detected in the urine of healthy volunteers taking a 50 mg radiolabeled dose of fluconazole; a glucuronidated metabolite on the hydroxyl moiety (6.5%) and a fluconazole N-oxide metabolite (2%).The same study indicated that no signs of metabolic cleavage of fluconazole were observed, suggesting a difference in metabolism when compared to other agents in the same drug class, which are heavily metabolized in the liver. |
| Route of elimination | In normal volunteers, fluconazole is cleared primarily by renal excretion, with approximately 80% of the administered dose measured in the urine as unchanged drug.About 11% of the dose is excreted in the urine as metabolites.. A study of a 50mg radiolabeled dose of fluconazole revealed that 93.3% of the dose was found excreted in the urine. **A note on renal failure** The pharmacokinetics of fluconazole are significantly affected by renal dysfunction. The dose of fluconazole may need to be reduced in patients with decreased renal function. A 3-hour hemodialysis treatment lowers plasma fluconazole concentrations by about 50%. |
| Volume of distribution | The apparent volume of distribution is said to be similar to the volume of distribution of total body water.One clinical study of healthy volunteers administered 50 mg/kg of fluconazole was 39L, based on a body weight of 60kg. Fluconazole shows substantial penetration in many body fluids, which is a property that renders it an ideal treatment for systemic fungal infections, especially when administered over a longer time.Fluconazole is found in high concentrations in the stratum corneum and dermis-epidermis of skin, in addition to eccrine sweat. Fluconazole is found to accumulate especially well in the stratum corneum, which is beneficial in superficial fungal infections.Saliva and sputum concentrations of fluconazole are found to be similar to the plasma concentrations.In patients diagnosed with fungal meningitis, fluconazole CSF (cerebrospinal fluid) levels are measured to be about 80% of the corresponding plasma levels. Therefore, fluconazole crosses the blood-brain barrier.The meninges are increasingly permeable to fluconazole in states of inflammation, facilitating treatment in meningitis. |
| Clearance | This drug is mainly eliminated by the kidneys and the mean body clearance in adults is reported to be 0.23 mL/min/kg.One clinical study of healthy subjects showed total clearance of 19.5 ± 4.7 mL/min and renal clearance of 14.7 ± 3.7 mL/min (1.17 ± 0.28 and 0.88 ± 0.22 L/h). Clearance in the pediatric population varies according to age, as does clearance in patients with renal failure. |
Formulation & handling
- Oral formulations are straightforward due to good aqueous solubility and food‑independent absorption, enabling simple tablet, capsule, and suspension designs.
- Parenteral and IV solutions require attention to pH control and solvent compatibility to maintain fluconazole’s solubility and chemical stability in aqueous media.
- As a small, chemically stable solid API, it handles well in standard milling and blending operations, with minimal sensitivity to moisture or temperature during processing.
Regulatory status
| Lifecycle | Patent protection for this API has lapsed in major markets, and generic competition is established in both the US and Canada. The product is therefore in a late‑lifecycle stage with a mature, stable market presence. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Fluconazole was introduced by a single originator, with numerous global manufacturers now producing the API and finished forms. Branded and generic products are well established in the US and Canada, reflecting long‑standing worldwide availability. Patent expiry occurred years ago, so the market already supports extensive generic competition across oral and injectable formulations. |
|---|
Safety
| Toxicity | **Acute oral toxicity (LD50)**: 1271 mg/kg (rat) [MSDS] **Overdose information** Fluconazole overdoses have been associated with hallucination and paranoia, sometimes in combination.In cases of overdose, employ supportive treatment. Gastric lavage may be necessary.Other modalities such as forced diuresis or hemodialysis may also be used. **A note on liver toxicity** The FDA label warns that this drug carries a risk of hepatotoxicity. Rare but serious cases of serious hepatic toxicity have been reported, especially in patients with serious underlying medical conditions using fluconazole. This group of patients has an increased risk of fatality when using fluconazole.In patients with existing liver dysfunction, use caution during fluconazole therapy. Those who are found to have abnormal liver function tests during therapy should be carefully monitored for the development of increasingly severe injury to the liver. Fluconazole should be stopped if its use is likely to be the underlying cause of liver injury, and medical attention should be sought.Fluconazole induced hepatotoxicity is usually reversible. **Carcinogenesis, mutagenesis, and impairment of fertility** Fluconazole demonstrated no evidence of carcinogenic risk in mice and rats treated orally for 24 months at doses equivalent to approximately 2-7 time the recommended human dose). Male rats given fluconazole at doses equivalent to supratherapeutic human doses showed an increased incidence of hepatocellular adenomas. Cytogenetic studies in vivo and in vitro demonstrated no sign of chromosomal mutation. The significance of these findings for humans is unknown. **Use in pregnancy** There are no sufficient and well-controlled studies of fluconazole use in pregnant women. Available human data do not show an increased risk of congenital anomalies after pregnant women were treated with standard doses (<200 mg/day) of fluconazole, either in a single dose or multiple doses in the first trimester did not appear to impact the fetus negatively.Several case reports describe rare but striking congenital anomalies observed in infants who were exposed to fluconazole at high doses reaching 400-800 mg/day, primarily in the first trimester of pregnancy. Similar findings were observed in animal studies. If this drug is administered during pregnancy, or if the patient becomes pregnant while taking fluconazole, the risk should be discussed thoroughly. **Use in nursing** Fluconazole is secreted in breastmilk at high concentrations. Exercise caution if this drug is used during nursing. |
|---|
High Level Warnings:
- Acute oral LD50 in rats is 1271 mg/kg, indicating moderate toxicity
- High exposures have been associated with CNS effects such as hallucinations and paranoia
- Documented hepatotoxic potential includes rare severe hepatic injury and increased adenoma incidence in male rats at supratherapeutic doses
Fluconazole is a type of Antimycotics
Antimycotics, a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs), are essential in the treatment of various fungal infections. These powerful medications target and eliminate harmful fungi that can cause infections in humans.
Antimycotics are classified into two main types: systemic and topical. Systemic antimycotics are administered orally or intravenously and work by circulating throughout the body, treating systemic fungal infections that affect internal organs or spread throughout the bloodstream. On the other hand, topical antimycotics are applied externally to treat localized fungal infections such as athlete's foot or yeast infections.
The efficacy of antimycotics lies in their ability to disrupt fungal cell membranes, inhibit the synthesis of fungal DNA or proteins, or interfere with essential metabolic processes specific to fungi. This targeted action minimizes damage to human cells, making these medications relatively safe for patients.
Commonly prescribed antimycotics include azoles, polyenes, allylamines, and echinocandins. Azoles inhibit the synthesis of ergosterol, a vital component of fungal cell membranes, while polyenes bind to ergosterol, resulting in the formation of pores that lead to cell death. Allylamines disrupt the synthesis of ergosterol and inhibit the activity of squalene epoxidase, an enzyme involved in ergosterol production. Echinocandins target the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall.
Antimycotics play a crucial role in the management of fungal infections, offering relief to patients and aiding in their recovery. As with any medication, it is important to follow healthcare professionals' guidance regarding dosage, duration of treatment, and potential side effects to ensure optimal therapeutic outcomes.
Fluconazole (Antimycotics), classified under Antifungals
Antifungals are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) designed to combat fungal infections. These medications are developed to target and eliminate fungi, including yeasts and molds, which can cause a range of diseases in humans and animals.
Antifungals work by interfering with specific components or processes essential for fungal growth and reproduction. They may inhibit the synthesis of fungal cell walls or disrupt the production of ergosterol, a crucial component of fungal cell membranes. By targeting these key mechanisms, antifungal APIs effectively hinder the growth and spread of fungal infections.
The diversity within the antifungal category is reflected in the various classes of antifungal APIs available. Azoles, polyenes, echinocandins, and allylamines are common classes of antifungals. Each class exhibits unique mechanisms of action and targets specific types of fungi. This diversity enables healthcare professionals to tailor treatment plans to the specific fungal infection, optimizing therapeutic outcomes.
Antifungal APIs find application in various pharmaceutical formulations, including oral medications, topical creams, ointments, and intravenous solutions. They are crucial for the treatment of common fungal infections like athlete's foot, ringworm, vaginal yeast infections, and oral thrush. Additionally, antifungals play a crucial role in managing serious systemic fungal infections that can pose significant health risks, especially in immunocompromised individuals.
Overall, antifungal APIs are indispensable tools in the fight against fungal infections, offering effective treatment options and improving the quality of life for patients suffering from these conditions. With ongoing research and development, the antifungal category continues to evolve, providing innovative solutions to combat the ever-changing landscape of fungal pathogens.
Fluconazole API manufacturers & distributors
Compare qualified Fluconazole API suppliers worldwide. We currently have 22 companies offering Fluconazole 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 |
|---|---|---|---|---|---|
| Asence Pharma | Producer | India | India | CoA, WC | 6 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Chemo Iberica | Producer | Spain | Spain | CEP, CoA | 12 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 164 products |
| Darshan Pharmachem (P) Li... | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 10 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP | 48 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Ipca Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, WC | 69 products |
| Kleem Pharmaceuticals | Producer | India | India | CoA | 22 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Kromozome | Distributor | India | India | CoA, GDP, GMP, WHO-GMP | 17 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 201 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, GMP, USDMF | 51 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Zhejiang Genebest Pharmac... | Producer | China | China | CoA | 3 products |
When sending a request, specify which Fluconazole 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 Fluconazole 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 Fluconazole API
Sourcing
What matters most when sourcing GMP-grade Fluconazole?
The key considerations are verifying that the API is manufactured under GMP and supported by documentation meeting US and Canadian regulatory requirements. Given the large number of global producers, confirming the supplier’s regulatory history, quality controls, and traceability is essential. Long‑standing generic availability also makes it important to assess consistency of specifications across different manufacturing sites.
Which documents are typically required when sourcing Fluconazole API?
Request the core API documentation set: CoA (21 companies), GMP (16 companies), FDA (9 companies), CEP (9 companies), USDMF (7 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Fluconazole API?
Known or reported manufacturers for Fluconazole: Xi'an Tian Guangyuan Biotech Co.,Ltd, Aurora Industry Co., Ltd, Tresinde Biotech, Global Pharma Tek, SETV Global, LGM Pharma, AXXO GmbH, Tenatra Exports Private Limited, Kromozome, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Fluconazole API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Fluconazole manufacturers?
Audit reports may be requested for Fluconazole: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Fluconazole API on Pharmaoffer?
Reported supplier count for Fluconazole: 21 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Fluconazole API?
Production countries reported for Fluconazole: India (11 producers), China (4 producers), Slovenia (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Fluconazole usually hold?
Common certifications for Fluconazole suppliers: CoA (21 companies), GMP (16 companies), FDA (9 companies), CEP (9 companies), USDMF (7 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Fluconazole (CAS 86386-73-4) used for?
Fluconazole is used to treat systemic and mucosal Candida infections, including vaginal, oropharyngeal, esophageal, urinary tract, and intra‑abdominal candidiasis, as well as systemic candidemia. It is also used for cryptococcal meningitis and as prophylaxis in high‑risk patients undergoing bone marrow transplantation.
Which therapeutic class does Fluconazole fall into?
Fluconazole belongs to the following therapeutic categories: 14-alpha Demethylase Inhibitors, Agents causing hyperkalemia, Anti-Infective Agents, Antifungal Agents, Antifungals for Dermatological Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Fluconazole mainly prescribed for?
The primary indications for Fluconazole: Fluconazole can be administered in the treatment of the following fungal infections:, Vaginal yeast infections caused by Candida, Systemic Candida infections, Both esophageal and oropharyngeal candidiasis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Fluconazole work?
Fluconazole is a very selective inhibitor of fungal cytochrome P450 dependent enzyme _lanosterol 14-α-demethylase_. This enzyme normally works to convert _lanosterol_ to _ergosterol_, which is necessary for fungal cell wall synthesis. The free nitrogen atom located on the azole ring of Fluconazole binds with a single iron atom located in the heme group of lanosterol 14-α-demethylase.This prevents oxygen activation and, as a result, inhibits the demethylation of lanosterol, halting the process of ergosterol biosynthesis.Methylated sterols are then found to accumulate in the fungal cellular membrane, leading to an arrest of fungal growth.These accumulated sterols negatively affect the structure and function of the fungal cell plasma membrane.
Fluconazole resistance may arise from an alteration in the amount or function of the target enzyme (lanosterol 14-α-demethylase), altered access to this enzyme, or a combination of the above.Other mechanisms may also be implicated, and studies are ongoing.
What should someone know about the safety or toxicity profile of Fluconazole?
Fluconazole shows moderate acute toxicity in animals, with an oral LD50 of 1271 mg/kg in rats. Clinically, it is generally well tolerated, but hepatic enzyme elevations and rare severe hepatotoxicity have been observed, and high exposures have produced CNS effects such as hallucinations and paranoia. It inhibits multiple cytochrome P450 enzymes, creating potential for drug interactions. QT prolongation risk and the need for dose adjustments in renal impairment should also be considered.
What are important formulation and handling considerations for Fluconazole as an API?
Important considerations include its good aqueous solubility and food‑independent absorption, which support simple oral tablet, capsule, and suspension formulations. IV formulations require controlled pH and compatible solvents to maintain solubility and stability in aqueous solutions. The API is chemically stable and generally easy to process, with standard milling and blending sufficient and minimal sensitivity to moisture or temperature during handling.
Is Fluconazole a small molecule?
Fluconazole is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Fluconazole?
Oral Fluconazole is chemically stable and has good aqueous solubility, so standard tablets, capsules, and suspensions are generally uncomplicated to formulate. It shows minimal sensitivity to moisture or temperature during processing. No special stability concerns are noted for oral forms beyond routine control of excipients appropriate for capsules or powder‑for‑suspension products.
Regulatory
Where is Fluconazole approved or in use globally?
Fluconazole is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Fluconazole right now?
Fluconazole is regulated in Canada and the US, where it is subject to standard oversight for approved active pharmaceutical ingredients. The provided context does not indicate any active patent protections.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Fluconazole procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Fluconazole. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Fluconazole included in the PRO Data Insights coverage?
PRO Data Insights coverage for Fluconazole: 7664 verified transactions across 1935 suppliers and 834 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Fluconazole?
Market report availability for Fluconazole: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
