Anti-Fungal APIs
Premium Antifungal Active Pharmaceutical Ingredients for Mycosis Treatment
About Anti-Fungal APIs
Holiness Pharmaceutical manufactures and exports high-quality Anti-Fungal APIs for treating systemic and topical fungal infections. Our portfolio includes azole antifungals and other antimycotic agents manufactured under WHO-GMP standards. We serve pharmaceutical companies globally, providing APIs for developing medications that treat candidiasis, dermatophytosis, and serious systemic fungal infections.
Key Features
- WHO-GMP certified antifungal manufacturing facility
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Both systemic and topical antifungal agents
- Advanced synthesis technology for azole compounds
- Multiple polymorphic forms with controlled specifications
- Comprehensive impurity profiling and genotoxic control
- Complete regulatory documentation and DMF support
- Technical support for various dosage forms
Application Areas
Systemic Fungal Infections
Treatment of candidemia, cryptococcal meningitis, and invasive fungal diseases
Dermatophyte Infections
Treatment of athlete's foot, ringworm, and fungal nail infections
Vaginal Candidiasis
Management of yeast infections and recurrent vulvovaginal candidiasis
Oral Thrush
Treatment of oropharyngeal candidiasis in immunocompromised patients
Prophylaxis in Immunocompromised
Prevention of fungal infections in cancer and transplant patients
Quality Assurance
Our anti-fungal APIs undergo comprehensive quality testing including HPLC analysis for purity and related substances, polymorphic form characterization using XRD and DSC, residual solvent analysis by GC, genotoxic impurity screening, heavy metal testing, and thorough microbiological evaluation including sterility testing for parenteral products. Each batch meets stringent international standards for antifungal medications.
Our Anti-Fungal APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Clotrimazole API | 23593-75-1 | IP/BP/USP | API Powder | View Product |
Fluconazole API | 86386-73-4 | IP/BP/USP | API Powder | View Product |
Ketoconazole API | 65277-42-1 | IP/BP/USP | API Powder | View Product |
Luliconazole API | 187164-19-8 | IP/BP/USP | API Powder | View Product |
Tioconazole API | 65899-73-2 | EP / USP | API Powder | View Product |
Tioconazole API | 65899-73-2 | EP / USP | API Powder | View Product |
Tioconazole API | 65899-73-2 | EP / USP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Fungal APIs?
Anti-Fungal APIs are active pharmaceutical ingredients that treat fungal infections by inhibiting fungal cell membrane synthesis or function. They include azoles (fluconazole, ketoconazole), which inhibit ergosterol synthesis, and other classes that disrupt fungal cell walls. These are used for both superficial skin infections and life-threatening systemic mycoses.
Which anti-fungal APIs does Holiness Pharmaceutical manufacture?
We manufacture Fluconazole (systemic triazole), Ketoconazole (imidazole for topical and oral use), Clotrimazole (topical imidazole), and Tioconazole (topical imidazole). All products meet IP, BP, USP, or EP standards and are suitable for oral, topical, and parenteral formulations depending on the specific API.
What is the difference between imidazoles and triazoles?
Both are azole antifungals that inhibit ergosterol synthesis. Imidazoles (ketoconazole, clotrimazole) contain two nitrogen atoms in the azole ring and are primarily used topically due to side effects. Triazoles (fluconazole) have three nitrogen atoms, offering better oral bioavailability, fewer side effects, and broader spectrum, making them preferred for systemic infections.
How do you ensure polymorphic consistency in azole antifungals?
Azole antifungals can exist in multiple polymorphic forms affecting solubility and bioavailability. We control crystallization parameters including temperature, solvent systems, and cooling rates, and characterize each batch using XRD, DSC, and FTIR. We maintain consistent polymorphic form throughout manufacturing and storage, ensuring reproducible dissolution and therapeutic effects.
Can you provide micronized grades for improved bioavailability?
Yes, we offer micronized grades of poorly soluble antifungals to enhance dissolution and bioavailability. Micronization increases surface area, improving absorption rates particularly for oral formulations. We provide particle size specifications and distribution data optimized for tablets, capsules, and suspension formulations.
What specifications do you offer for topical antifungal formulations?
For topical applications, we provide APIs with appropriate particle size for creams, ointments, and gels, low bioburden suitable for topical products, compatibility data with common cream bases and excipients, and stability in various topical formulations. We support development of creams, vaginal tablets, pessaries, and dermatological preparations.
Do you manufacture APIs suitable for parenteral antifungal products?
Yes, we manufacture Fluconazole meeting parenteral grade specifications including bacterial endotoxin limits, sterility assurance, particulate matter control, and compatibility with IV solutions. We provide technical support for developing IV infusion products used in treating serious systemic fungal infections in hospital settings.
What are the storage requirements for anti-fungal APIs?
Most anti-fungal APIs should be stored in tightly closed, light-resistant containers protected from moisture at controlled room temperature (15-25°C). Some azoles are photosensitive requiring amber packaging. We provide comprehensive stability data under ICH conditions and specific storage recommendations for each product to maintain quality throughout shelf life.