- Raw materials
- Antifungals
- Luliconazole
- Suppliers by country
- Japan
Filters
Filter
Custom request?
Type
Production region
Qualifications
Country of origin
Luliconazole API from Japan Manufacturers & Suppliers
8 verified results
Get full market intelligence report
All Luliconazole data. Full access. Full negotiation power
€399,-
Commercial-scale Suppliers
Producer
Produced in
China|
Employees: 600+
|
Audit Report:
Certifications:
GMP
|
FDA|
USDMF|
MSDS|
CoAAll certificates
GMP
FDA
USDMF
MSDS
CoA
Producer
Produced in
India|
Employees: 200+
|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
CoAAll certificates
GMP
MSDS
BSE/TSE
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Producer
Produced in
India|
Employees: 19
|
Audit Report:
Certifications:
GMP
|
FDA|
CoAAll certificates
GMP
FDA
CoA
Producer
Produced in
Japan|
Audit Report:
Certifications:
CoA
All certificates
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
China|
Audit Report:
Certifications:
coa
All certificates
coa
Get full market intelligence report
€399,-
All Luliconazole data. Full access. Full negotiation power
Producer
Produced in
Japan|
Audit Report:
Certifications:
USDMF
|
CoA|
JDMFAll certificates
USDMF
CoA
JDMF
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
FDA|
USDMF|
ISO 9001|
CoAAll certificates
GMP
FDA
USDMF
ISO 9001
CoA
WHO-GMP
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Luliconazole | CAS No: 187164-19-8 | GMP-certified suppliers
A medication that treats interdigital tinea pedis, tinea cruris, and tinea corporis to support management of superficial fungal infections.
Therapeutic categories
Anti-Infective AgentsAntifungal AgentsAntifungals for Dermatological UseAntifungals for Topical UseAzole AntifungalsCytochrome P-450 CYP2C19 Inhibitors
Generic name
Luliconazole
Molecule type
small molecule
CAS number
187164-19-8
DrugBank ID
DB08933
Approval status
Approved drug
ATC code
D01AC18
Primary indications
- Luliconazole is indicated for the treatment of interdigital tinea pedis, tinea cruris, or tinea corporis infections caused by Trichophyton rubrum and Epidermophyton floccosum
Product Snapshot
- Topical small‑molecule API used in cream formulations
- Primary use is for dermatophyte infections such as interdigital tinea pedis, tinea cruris, and tinea corporis
- Approved for the US market
Clinical Overview
Luliconazole (CAS 187164-19-8) is an imidazole antifungal used topically for dermatophyte infections. It is approved in the United States and Japan and is marketed in the U.S. under the brand name Luzu. The API belongs to the dichlorobenzenes, characterized by a benzene ring substituted with two chlorine atoms.
The clinical indication includes interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum. Its pharmacodynamic activity is fungicidal against these organisms, with effects attributed to disruption of fungal cell membrane integrity.
Luliconazole’s mechanism of action has not been fully defined. Available evidence supports inhibition of lanosterol demethylase, a key enzyme required for ergosterol biosynthesis. Reduced ergosterol content compromises fungal membrane structure and function, contributing to loss of viability.
As a topical agent, luliconazole demonstrates minimal systemic involvement, and systemic pharmacokinetic parameters are not central to its clinical use. Published information indicates low systemic exposure after dermal administration, but detailed absorption, distribution, metabolism, or excretion values are not established in the provided data.
Safety considerations primarily relate to local tolerability. Application-site reactions such as erythema or irritation have been observed. Systemic adverse events are uncommon due to limited absorption. Luliconazole is classified among azole antifungals and is identified as an inhibitor of CYP2C19 and CYP3A isoenzymes, but the clinical significance of these interactions is minimal in topical treatment settings where systemic concentrations are low.
Luliconazole is used in dermatological practice where short-course, once-daily regimens are common for the approved indications. Its approval status and global dermatology usage contexts support its role in managing superficial fungal infections.
For API procurement, suppliers should provide material produced under appropriate GMP conditions with defined impurity controls, stereochemical integrity, and verification of identity consistent with regulatory documentation to support downstream formulation and registration activities.
The clinical indication includes interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum. Its pharmacodynamic activity is fungicidal against these organisms, with effects attributed to disruption of fungal cell membrane integrity.
Luliconazole’s mechanism of action has not been fully defined. Available evidence supports inhibition of lanosterol demethylase, a key enzyme required for ergosterol biosynthesis. Reduced ergosterol content compromises fungal membrane structure and function, contributing to loss of viability.
As a topical agent, luliconazole demonstrates minimal systemic involvement, and systemic pharmacokinetic parameters are not central to its clinical use. Published information indicates low systemic exposure after dermal administration, but detailed absorption, distribution, metabolism, or excretion values are not established in the provided data.
Safety considerations primarily relate to local tolerability. Application-site reactions such as erythema or irritation have been observed. Systemic adverse events are uncommon due to limited absorption. Luliconazole is classified among azole antifungals and is identified as an inhibitor of CYP2C19 and CYP3A isoenzymes, but the clinical significance of these interactions is minimal in topical treatment settings where systemic concentrations are low.
Luliconazole is used in dermatological practice where short-course, once-daily regimens are common for the approved indications. Its approval status and global dermatology usage contexts support its role in managing superficial fungal infections.
For API procurement, suppliers should provide material produced under appropriate GMP conditions with defined impurity controls, stereochemical integrity, and verification of identity consistent with regulatory documentation to support downstream formulation and registration activities.
Identification & chemistry
| Generic name | Luliconazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 187164-19-8 |
| UNII | RE91AN4S8G |
| DrugBank ID | DB08933 |
Pharmacology
| Summary | Luliconazole is an antifungal agent that primarily targets fungal lanosterol demethylase (CYP51), a key enzyme in ergosterol biosynthesis. Inhibiting this pathway disrupts ergosterol production and alters fungal cell membrane integrity. Its pharmacodynamic effect includes fungicidal activity against Trichophyton rubrum and Epidermophyton floccosum. |
|---|---|
| Mechanism of action | The exact mechanism of action for luliconazole's anti-fungal activity is still not known, but luliconazole is thought to inhibit the enzyme lanosterol demethylase. Lanosterol demethylase is needed for the synthesis of ergosterol, which is a major component of the fungus cell membranes. |
| Pharmacodynamics | Luliconazole kills the organisms Trichophyton rubrum and Epidermophyton floccosum, most likely by altering their fungal cell membranes. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 51 | Yeast | inhibitor |
ADME / PK
| Absorption | Although luliconazole is administered topically, clinical studies have shown that after the first dose in patients with tina pedis, a maximum plasma concentration of 0.40 ± 0.76 ng/mL (mean ± SD) occurred in 16.9 ± 9.39 hours (mean ± SD). |
|---|---|
| Half-life | The half life of luliconazole has yet to be determined. |
| Protein binding | Plasma protein binding of luliconazole is >99%. |
| Metabolism | The metabolism of luliconazole has yet to be determined. |
| Route of elimination | The route of elimination of luliconazole has yet to be determined. |
| Volume of distribution | The volume of distribution was not quantified. |
| Clearance | The clearance of luliconazole has yet to be determined. |
Formulation & handling
- Low aqueous solubility and lipophilicity support incorporation into topical cream or ointment bases with suitable solubilizers or emulsifiers.
- Solid API requires controlled blending and dispersion to ensure uniformity in semi‑solid formulations.
- Chemical stability is generally good for a small aromatic molecule, but protection from excessive heat and light helps maintain potency in topical products.
Regulatory status
| Lifecycle | The API remains in a protected market phase in the US, with multiple patents extending into 2033–2034. Given these expiry dates and its sole presence in the US market, the product is still in an early‑to‑mid lifecycle stage with limited generic entry expected before the early 2030s. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Luliconazole is supplied primarily by a single originator company, with manufacturing focused on supporting the branded product marketed in the United States. Its commercial presence is largely limited to the U.S. market, with no broad evidence of established EU or other international branded distribution. Although an early patent has expired, multiple later‑expiring U.S. patents running into 2033–2034 indicate that significant generic competition is unlikely in the near term. |
|---|
Safety
| Toxicity | In clinical trials, no serious toxicity was reported, only local irritation (mild contact dermatitis and cellulitis) at the site of application was found. |
|---|
High Level Warnings:
- Reported adverse effects were limited to mild, localized reactions such as contact dermatitis and cellulitis at application sites
- No systemic or serious toxicity signals were identified in clinical evaluations
- Handling considerations primarily relate to minimizing dermal exposure to reduce the likelihood of local irritation
Luliconazole is a type of 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.
Luliconazole API manufacturers & distributors
Compare qualified Luliconazole API suppliers worldwide. We currently have 8 companies offering Luliconazole 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Dalian Wista Pharma Co Lt... | Producer | China | China | CoA | 16 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hamari Chemicals | Producer | Japan | Japan | CoA, JDMF, USDMF | 12 products |
| Maithri Drugs | Producer | India | India | CoA, USDMF | 12 products |
| Prachi Pharmaceuticals | Producer | India | India | CoA, FDA, GMP, ISO9001, USDMF, WHO-GMP | 12 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Viwit Pharmaceutical Co.,... | Producer | China | China | CoA, FDA, GMP, MSDS, USDMF | 18 products |
When sending a request, specify which Luliconazole 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 Luliconazole 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 Luliconazole API
Sourcing
What matters most when sourcing GMP-grade Luliconazole?
When sourcing GMP‑grade Luliconazole, it is important to account for the predominantly single‑source supply, as U.S. manufacturing is focused on the originator’s branded product. U.S. regulatory requirements should guide qualification and documentation needs. Later‑expiring patents through 2033–2034 also limit alternative suppliers, making verification of legitimate supply chains essential.
Which documents are typically required when sourcing Luliconazole API?
Request the core API documentation set: CoA (8 companies), USDMF (4 companies), GMP (4 companies), FDA (3 companies), MSDS (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Luliconazole API?
Known or reported manufacturers for Luliconazole: SETV Global, Viwit Pharmaceutical Co., Ltd., Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Luliconazole 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 Luliconazole manufacturers?
Audit reports may be requested for Luliconazole: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Luliconazole API on Pharmaoffer?
Reported supplier count for Luliconazole: 8 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Luliconazole API?
Production countries reported for Luliconazole: India (4 producers), China (2 producers), Japan (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Luliconazole usually hold?
Common certifications for Luliconazole suppliers: CoA (8 companies), USDMF (4 companies), GMP (4 companies), FDA (3 companies), MSDS (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Luliconazole (CAS 187164-19-8) used for?
Luliconazole is a topical imidazole antifungal used to treat interdigital tinea pedis, tinea cruris, and tinea corporis caused by dermatophytes such as Trichophyton rubrum and Epidermophyton floccosum. It acts primarily by inhibiting lanosterol demethylase, disrupting ergosterol synthesis and fungal cell membrane integrity.
Which therapeutic class does Luliconazole fall into?
Luliconazole belongs to the following therapeutic categories: Anti-Infective Agents, Antifungal Agents, Antifungals for Dermatological Use, Antifungals for Topical Use, Azole Antifungals. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Luliconazole mainly prescribed for?
The primary indications for Luliconazole: Luliconazole is indicated for the treatment of interdigital tinea pedis, tinea cruris, or tinea corporis infections caused by Trichophyton rubrum and Epidermophyton floccosum. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Luliconazole work?
The exact mechanism of action for Luliconazole's anti-fungal activity is still not known, but Luliconazole is thought to inhibit the enzyme lanosterol demethylase. Lanosterol demethylase is needed for the synthesis of ergosterol, which is a major component of the fungus cell membranes.
What should someone know about the safety or toxicity profile of Luliconazole?
Luliconazole’s safety profile is characterized mainly by mild, localized reactions such as erythema, irritation, contact dermatitis, or cellulitis at the application site. Systemic toxicity has not been identified, consistent with its minimal systemic absorption after topical use. Handling should focus on limiting unnecessary dermal exposure to reduce the likelihood of local irritation.
What are important formulation and handling considerations for Luliconazole as an API?
Luliconazole’s low aqueous solubility and lipophilicity favor incorporation into topical cream or ointment bases using appropriate solubilizers or emulsifiers to achieve uniform dispersion. The solid API should be blended under controlled conditions to ensure content uniformity in semi‑solid dosage forms. Although chemically stable, the API should be protected from excessive heat and light during processing and storage to maintain potency.
Is Luliconazole a small molecule?
Luliconazole is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Luliconazole?
Luliconazole is a chemically stable small aromatic molecule, but exposure to excessive heat and light can reduce potency. Its low aqueous solubility and lipophilicity indicate a need for appropriate solubilization and controlled handling during formulation. These general stability considerations apply regardless of the dosage form.
Regulatory
Where is Luliconazole approved or in use globally?
Luliconazole is reported as approved in the following major regions: US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Luliconazole right now?
In the United States, Luliconazole is approved by the FDA for topical treatment of certain fungal skin infections. Its regulatory status is stable, with requirements centered on standard quality, safety, and labeling compliance for topical antifungals. Patent protection is governed by any issued U.S. patents and associated listings in FDA’s Orange Book, which define the exclusivity framework for this ingredient.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Luliconazole procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Luliconazole. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Luliconazole included in the PRO Data Insights coverage?
PRO Data Insights coverage for Luliconazole: 820 verified transactions across 258 suppliers and 161 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Luliconazole?
Market report availability for Luliconazole: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
