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Itraconazole Structure

PRODUCT TYPE

API

GRADE

USP/EP

CHEMICAL FORMULA

C35H38Cl2N8O4

IUPAC NAME

1-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

CAS NO

84625-61-6

MOLECULAR WEIGHT

705.63 g/mol

CHEMICAL CLASS

Synthetic triazole derivative

THERAPEUTIC CLASS

Anti-Fungal

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to slightly yellow crystalline powder
Solubility Practically insoluble in water; soluble in methanol, ethanol, and dichloromethane
Melting Point 166–170°C
pH 3.0

Product Description

Itraconazole is a synthetic triazole antifungal agent used to treat a variety of fungal infections, including those affecting the skin, nails, and internal organs. It works by inhibiting fungal cytochrome P450 enzymes, blocking the synthesis of ergosterol, a key component of fungal cell membranes. Itraconazole is available in oral and intravenous formulations and is particularly effective against dermatophytes, yeasts, and systemic fungi such as Aspergillus. Due to its broad-spectrum activity and relatively favorable safety profile, itraconazole is widely used in both superficial and systemic fungal infections.

How Itraconazole Works

Itraconazole works by inhibiting the enzyme lanosterol 14α-demethylase, a fungal cytochrome P450 enzyme essential for converting lanosterol to ergosterol, a critical component of the fungal cell membrane. By blocking ergosterol synthesis, itraconazole disrupts the integrity and function of the fungal membrane, leading to impaired cell growth and eventually fungal cell death. This selective inhibition makes itraconazole effective against a wide range of fungal pathogens.

Use(s)

Adverse Effects

Why choose Salius for Itraconazole?

  1. WHO-GMP Certified Manufacturing
    Salius Pharma produces Itraconazole in facilities certified by the World Health Organization’s Good Manufacturing Practices (WHO-GMP), ensuring the API meets high-quality, safety, and purity standards required globally.
  2. Consistent Quality and Reliability
    They maintain strict quality control protocols to provide consistent, pharmaceutical-grade Itraconazole. This reliability helps pharmaceutical companies avoid batch failures and regulatory issues.
  3. Global Export Experience & Documentation Support
    Salius regularly exports APIs, provides regulatory documents (DMF, impurity profiles), and supports filings for international clients—even in stringent regulated markets.
  4. Documents We Provide
  5. Focus on Chronic Therapy APIs
    Salius specializes in APIs for chronic diseases, demonstrating expertise in producing reliable compounds like Itraconazole, often used in long-term treatments.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

Itraconazole is used to treat fungal infections such as aspergillosis, histoplasmosis, onychomycosis, and skin fungal infections.

It inhibits fungal ergosterol synthesis by blocking the enzyme lanosterol 14α-demethylase, disrupting the fungal cell membrane.

Yes, itraconazole capsules are better absorbed when taken with a full meal; the solution form is best on an empty stomach.

Yes, Salius Pharma Pvt. Ltd. exports Itraconazole API to various countries, including those in Africa and the Middle East. As an ISO 9001:2015 certified company recognized as a Government of India Star Export House, Salius Pharma has a strong presence in international markets. They have a history of exporting Itraconazole Hydrochloride Injection to destinations such as Uganda, Sri Lanka, Thailand, and Colombia.

Yes, Salius Pharma Pvt. Ltd. provides comprehensive technical support and documentation for their Itraconazole API. This includes regulatory dossiers in CTD/eCTD formats, Drug Master Files (DMFs) filed with US FDA and EU authorities, Certificates of Suitability (CEPs) compliant with European Pharmacopoeia standards, and detailed Certificates of Analysis (COAs) for batch-specific testing.

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