- Raw materials
- Antifungals
- Antimycotics
- Bifonazole
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Bifonazole API Manufacturers & Suppliers
4 verified results
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Commercial-scale Suppliers
Employees: 3500
All certificates
Employees: 275+
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Bifonazole | CAS No: 60628-96-8 | GMP-certified suppliers
A medication that treats common superficial fungal infections such as athlete’s foot, supporting reliable topical dermatological products for various antifungal applications.
Therapeutic categories
Primary indications
- Used for the treatment of various topical fungal infections, including athlete's foot (tinea pedis)
Product Snapshot
- Bifonazole is formulated primarily as topical cutaneous products such as creams, gels, lotions, sprays, solutions, ointments, powders, and foams
- It is used for superficial fungal infection management including tinea pedis and related dermatomycoses
- It is approved in multiple markets for topical use, with some oral or alternative routes remaining investigational
Clinical Overview
Its pharmacological activity is based on disruption of fungal cell membrane integrity. Bifonazole inhibits ergosterol biosynthesis by interfering with the fungal cytochrome P450 51 enzyme, also known as lanosterol 14‑alpha demethylase. Reduction in ergosterol content leads to structural instability of the membrane, increased permeability, and subsequent leakage of intracellular components. This mechanism supports broad antifungal activity against common dermatophytes and yeasts encountered in superficial infections.
Absorption following topical administration is limited, and systemic exposure is generally low. Distribution, metabolism, and elimination parameters are not comprehensively characterized due to minimal systemic availability. The low systemic absorption aligns with its use as a topical therapy rather than systemic antifungal treatment.
Safety considerations primarily relate to local tolerability. Reported effects include mild skin irritation, erythema, or pruritus at the application site. Systemic adverse effects are uncommon due to limited absorption. Bifonazole is noted to interact with cytochrome P450 pathways in vitro, including CYP3A and CYP2E1, but clinically meaningful systemic interactions are unlikely with topical use. It is not indicated for ophthalmic, oral, or parenteral administration.
Bifonazole is available in various topical formulations in multiple regions, commonly incorporated into creams, solutions, and powders for dermatological use. Product branding varies by market.
For API procurement, suppliers should provide consistent control of polymorphic form, purity profile, and residual solvent limits. Comprehensive analytical documentation, including specification data and evidence of GMP-compliant manufacturing, is important for ensuring compatibility with topical formulation development and regulatory submissions.
Identification & chemistry
| Generic name | Bifonazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 60628-96-8 |
| UNII | QYJ305Z91O |
| DrugBank ID | DB04794 |
Pharmacology
| Summary | Bifonazole is an imidazole antifungal that inhibits ergosterol synthesis by blocking the fungal cytochrome P450 51 enzyme, a key catalyst in lanosterol demethylation. Disruption of ergosterol production compromises membrane integrity and leads to fungal cell death. Its pharmacodynamic profile reflects targeted suppression of fungal membrane formation with minimal activity beyond its primary P450 targets. |
|---|---|
| Mechanism of action | Bifonazole works by inhibiting the production of a substance called ergosterol, which is an essential component of fungal cell membranes.It acts to destabilize the fungal cyctochrome p450 51 enzyme (also known as Lanosterol 14-alpha demethylase). This is vital in the cell membrance structure of the fungus. Its inhibition leads to cell lysis. The disruption in production of ergosterol disrupts the cell membrane and causes holes to appear. The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As bifonazole causes holes to appear in the cell membranes, essential constituents of the fungal cells can leak out. This kills the fungi. |
| Pharmacodynamics | Bifonazole is a type of antifungal medicine known as an imidazole. It kills fungi and yeasts by interfering with their cell membranes. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 51 | Yeast | inhibitor |
| Cytochrome P450 2B6 | Humans |
ADME / PK
| Absorption | Very low absorption following topical administration (0.6% of an applied dose). In cases of skin lesions absorption is increased (2.5%). |
|---|---|
| Half-life | 1-2 hours |
| Metabolism | Hepatic. |
Formulation & handling
- Bifonazole is a small, highly lipophilic molecule with very low aqueous solubility, favoring topical semisolid or powder formulations over systemic delivery.
- Its poor water solubility and solid-state form require solubilizers or suitable lipid/solvent systems for topical solutions or sprays.
- Stable as a solid but should be protected from excessive heat and light to maintain potency in topical formulations.
Regulatory status
Bifonazole 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.
Bifonazole (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.
Bifonazole API manufacturers & distributors
Compare qualified Bifonazole API suppliers worldwide. We currently have 4 companies offering Bifonazole 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 |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| ChemExpress | Producer | United States | China | CoA, GMP, ISO9001, MSDS, WC | 197 products |
| Erregierre | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 44 products |
| Vital Laboratories Pvt. L... | Producer | India | India | CoA, WC | 22 products |
When sending a request, specify which Bifonazole 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 Bifonazole 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 Bifonazole API
Sourcing
Which documents are typically required when sourcing Bifonazole API?
Which manufacturers are known to produce Bifonazole API?
How can I request quotes for Bifonazole API from GMP suppliers?
Is a GMP audit report available for Bifonazole manufacturers?
How many suppliers offer Bifonazole API on Pharmaoffer?
Which countries are known to manufacture Bifonazole API?
Which certifications do suppliers of Bifonazole usually hold?
Technical
What is Bifonazole (CAS 60628-96-8) used for?
Which therapeutic class does Bifonazole fall into?
What conditions is Bifonazole mainly prescribed for?
How does Bifonazole work?
What should someone know about the safety or toxicity profile of Bifonazole?
What are important formulation and handling considerations for Bifonazole as an API?
Is Bifonazole a small molecule?
Are there special stability concerns for oral Bifonazole?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Bifonazole procurement?
Is Bifonazole included in the PRO Data Insights coverage?
Where can I access the API market report for Bifonazole?
