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Miconazole | CAS No: 22916-47-8 | GMP-certified suppliers
A medication that provides localized treatment for oral and cutaneous candidiasis, vaginal yeast infections, and common dermatophyte conditions including athlete's foot, jock itch, and ringworm.
Therapeutic categories
Primary indications
- Miconazole is indicated for the local treatment of oropharyngeal candidiasis in adult patients and for the adjunctive treatment of diaper dermatitis complicated by candidiasis in immunocompetent patients aged four weeks and older
- Miconazole is available as both a suppository and cream for the treatment of vaginal yeast infections and the relief of associated vulvar itching and irritation
- Lastly, miconazole cream is effective in treating athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm infections (tinea corporis),pityriasis (formerly tinea) versicolor,and cutaneous candidiasis
Product Snapshot
- Miconazole is a topical, buccal, oral, and vaginal small-molecule antifungal available in multiple semi-solid, liquid, and solid formulations
- It is used for fungal infections including oropharyngeal and cutaneous candidiasis, dermatophyte infections, and vaginal yeast infections
- It is approved in the US and Canada with additional investigational and veterinary-use statuses
Clinical Overview
Pharmacologically, miconazole exhibits broad-spectrum antifungal activity with additional activity against select Gram-positive bacteria. Because it is administered topically, systemic exposure is minimal, and pharmacodynamic effects are largely confined to treated tissues.
Miconazole acts primarily through inhibition of fungal CYP450 14α-lanosterol demethylase, disrupting ergosterol synthesis and altering membrane permeability. The drug additionally inhibits fungal peroxidase and catalase, increasing intracellular reactive oxygen species and promoting apoptosis. Inhibition of lanosterol demethylation also leads to increased farnesol levels, which affect Candida quorum sensing and suppress the yeast-to-hypha transition while modulating efflux transporter activity. These combined actions contribute to reduced biofilm formation and enhanced susceptibility to azole therapy.
Absorption after topical or intravaginal administration is low, resulting in negligible systemic distribution and minimal metabolism or renal excretion. Drug interactions mediated by systemic CYP inhibition are therefore unlikely in standard topical use, although miconazole is a known inhibitor of multiple CYP isoforms in vitro.
Safety considerations primarily involve local reactions such as irritation or hypersensitivity, with rare reports of anaphylaxis. Intravaginal use requires avoidance of barrier contraceptives and concurrent tampon use due to potential product interaction and reduced efficacy.
Reference brands vary by region and include oral gels, dermatologic creams, and intravaginal formulations.
For API sourcing, procurement teams should prioritize suppliers with validated control of polymorphic form, impurity profile, and residual solvent levels, supported by GMP certification and region-specific regulatory documentation.
Identification & chemistry
| Generic name | Miconazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 22916-47-8 |
| UNII | 7NNO0D7S5M |
| DrugBank ID | DB01110 |
Pharmacology
| Summary | Miconazole is an azole antifungal that inhibits CYP450 14α‑lanosterol demethylase, disrupting ergosterol synthesis and fungal cell membrane integrity. It also increases intracellular reactive oxygen species through peroxidase and catalase inhibition and alters quorum‑sensing pathways by elevating farnesol levels, reducing biofilm formation and efflux transporter activity. These combined effects impair fungal viability across a range of Candida and dermatophyte infections. |
|---|---|
| Mechanism of action | Miconazole is an azole antifungal used to treat a variety of conditions, including those caused by _Candida_ overgrowth. Unique among the azoles, miconazole is thought to act through three main mechanisms.The primary mechanism of action is through inhibition of the CYP450 14α-lanosterol demethylase enzyme, which results in altered ergosterol production and impaired cell membrane composition and permeability, which in turn leads to cation, phosphate, and low molecular weight protein leakage. In addition, miconazole inhibits fungal peroxidase and catalase while not affecting NADH oxidase activity, leading to increased production of reactive oxygen species (ROS).Increased intracellular ROS leads to downstream pleiotropic effects and eventual apoptosis. Lastly, likely as a result of lanosterol demethylation inhibition, miconazole causes a rise in intracellular levels of farnesol. This molecule participates in quorum sensing in _Candida_, preventing the transition from yeast to mycelial forms and thereby the formation of biofilms, which are more resistant to antibiotics.In addition, farnesol is an inhibitor of drug efflux ABC transporters, namely _Candida_ CaCdr1p and CaCdr2p, which may additionally contribute to increased effectiveness of azole drugs. |
| Pharmacodynamics | Miconazole is an azole antifungal that functions primarily through inhibition of a specific demethylase within the CYP450 complex.As miconazole is typically applied topically and is minimally absorbed into the systemic circulation following application, the majority of patient reactions are limited to hypersensitivity and cases of anaphylaxis.Patients using intravaginal miconazole products are advised not to rely on contraceptives to prevent pregnancy and sexually transmitted infections, as well as not to use tampons concurrently. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 51 | Yeast | inhibitor |
| Nitric oxide synthase, endothelial | Humans | inhibitor |
| Nitric oxide synthase, inducible | Humans | inhibitor |
ADME / PK
| Absorption | Miconazole given to healthy volunteers as a single 50 mg oral tablet produced a mean C<sub>max</sub> of 15.1 ± 16.2 mcg/mL, a mean AUC<sub>0-24</sub> of 55.2 ± 35.1 mcg\*h/mL, and a median T<sub>max</sub> of 7 hours (range 2.0-24.1). In these patients measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL. Topical miconazole is absorbed poorly into the systemic circulation.In pediatric patients aged 1-21 months given multiple topical applications of miconazole ointment for seven days, the plasma miconazole concentration was less than 0.5 ng/mL in 88% of the patients, with the remaining patients having a concentration of 0.57 and 0.58 ng/mL, respectively.Similarly, patients. administered with a vaginal 1200 mg ovule had a mean C<sub>max</sub> of 10.71 ng/mL, mean T<sub>max</sub> of 18.4 hours, and mean AUC<sub>0-96</sub> of 477.3 ng\*h/mL. |
|---|---|
| Half-life | Miconazole has a terminal half-life of 24 hours. |
| Protein binding | _In vitro_ data suggests that miconazole binds human serum albumin, however, the clinical significance of this observation is unclear. |
| Metabolism | Miconazole is metabolized in the liver and does not give rise to any active metabolites. |
| Route of elimination | Miconazole is excreted through both urine and feces; less than 1% of unchanged miconazole is recovered in urine. |
| Volume of distribution | A 1200 mg miconazole vaginal suppository resulted in a calculated apparent volume of distribution of 95 546 L while a 100 mg vaginal cream yielded an apparent volume of distribution of 10 911L. |
Formulation & handling
- Low aqueous solubility and high lipophilicity favor topical, mucosal, and vaginal formulations, typically requiring lipidic or solvent-based systems for adequate dispersion.
- Solid-state API is stable and compatible with creams, ointments, gels, aerosols, and suspensions, but formulation often needs solubilizers or emulsifiers to prevent crystallization.
- Oral and buccal gels rely on local action; systemic absorption is minimal, so stability considerations focus on maintaining uniformity and preventing precipitation in semi-solid matrices.
Regulatory status
| Lifecycle | The API remains under U.S. patent protection until 2028, while earlier patents have already expired, indicating a market that is partially matured but not fully open to generic competition. With commercialization limited to the US and Canada, its lifecycle is in a late‑protection phase approaching broader generic entry. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Miconazole is supplied by numerous packagers and distributors, indicating a mature landscape in which the original developer’s role is limited and broad secondary manufacturing and repackaging activity supports market availability. Branded and non‑branded products are widely established in the US and Canada. Most listed patents have expired, with one extending to 2028, suggesting that generic competition is already well established with only limited protection remaining for specific formulations or uses. |
|---|
Safety
| Toxicity | Miconazole overdose has not been reported.Patients experiencing an overdose are at an increased risk of severe adverse effects such as headache, skin irritation, diarrhea, nausea, vomiting, abdominal pain, and dysgeusia. Symptomatic and supportive measures are recommended. Miconazole has an oral LD<sub>50</sub> of 500 mg/kg in rats.[MSDS] |
|---|
- High acute oral toxicity in animals, with an LD50 of approximately 500 mg/kg in rats, indicates the need for controlled handling to limit ingestion exposure
- Exposure to elevated doses may elicit adverse effects including headache, skin irritation, gastrointestinal disturbances, and taste alteration
- Processes should account for the potential for local irritation, particularly with dermal or mucosal contact during manufacturing or formulation activities
Miconazole 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.
Miconazole (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.
Miconazole API manufacturers & distributors
Compare qualified Miconazole API suppliers worldwide. We currently have 16 companies offering Miconazole API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| Ajinomoto | Producer | Japan | Unknown | CoA, USDMF | 24 products |
| Corden Pharma | Producer | Germany | Italy | CoA, GMP, USDMF | 45 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Italy | CoA, GMP, ISO9001, MSDS | 170 products |
| Erregierre | Producer | Italy | Italy | CoA, USDMF | 44 products |
| Gedeon Richter | Producer | Hungary | Hungary | CoA, GMP | 48 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Gufic Biosciences | Producer | India | India | CoA, WC | 6 products |
| Janssen Pharma | Producer | Belgium | Unknown | CEP, CoA, GMP, JDMF, USDMF | 63 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, USDMF | 51 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sharon Bio-Medicine | Producer | India | India | CoA, GMP, WC | 12 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Yung Zip Chemical | Producer | Taiwan | Taiwan | CoA, JDMF, USDMF | 12 products |
When sending a request, specify which Miconazole 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 Miconazole 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 Miconazole API
Sourcing
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Technical
What is Miconazole (CAS 22916-47-8) used for?
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Regulatory
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Pharmaoffer
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