Antifungal

ItraconazoleThird Party Manufacturing in India

Looking to get Itraconazole manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
84625-61-6
Drug Class
Triazole antifungal
Molecular Formula
C₃₅H₃₈Cl₂N₈O₄
Molecular Weight
705.6 g/mol
Grade Standards
IP, BP, USP
Therapeutic Category
Antifungal
MOQ
Contact us for MOQ — varies by product type
Dosage Forms
Tablet

Mechanism of Action

Itraconazole works by inhibiting the synthesis of ergosterol, an essential component of the fungal cell membrane. It binds to the fungal cytochrome P450 enzyme lanosterol 14α-demethylase, blocking the conversion of lanosterol to ergosterol. This disruption in ergosterol production compromises the integrity and function of the fungal cell membrane, leading to increased membrane permeability and leakage of intracellular contents. The fungistatic activity of Itraconazole results from the accumulation of toxic methylated sterol precursors and the depletion of ergosterol within the fungal cell. Unlike the related triazole fluconazole, Itraconazole exhibits a broader spectrum of activity and greater potency against filamentous fungi. It is effective against a wide range of dermatophytes, yeasts, and moulds, making it a versatile choice for systemic and superficial fungal infections. Itraconazole is well-tolerated in most patient populations and shows excellent tissue penetration, particularly in keratin-rich tissues where it accumulates at high concentrations.

Therapeutic Uses & Indications

Therapeutic Uses

Itraconazole is prescribed for the treatment of:

  • Onychomycosis: Fungal nail infections caused by dermatophytes, effectively treated with pulsed dosing regimens.
  • Oral and Oesophageal Candidiasis: Mucosal Candida infections, particularly in immunocompromised patients.
  • Dermatophytosis: Tinea corporis, tinea cruris, tinea pedis, and tinea versicolor infections of the skin.
  • Systemic Fungal Infections: Histoplasmosis, blastomycosis, aspergillosis, and sporotrichosis in non-immunocompromised hosts.
  • Vulvovaginal Candidiasis: Recurrent or resistant vaginal yeast infections.

Why Manufacturers Choose Itraconazole

Itraconazole remains one of the most widely prescribed triazole antifungals globally, with consistent demand from both domestic Indian markets and regulated export markets including the US, EU, and Middle East. Its broad spectrum of activity and multiple dosage forms — tablets, capsules, and oral solutions — make it a high-volume molecule for third party manufacturing. The molecule's proven safety profile and inclusion in the WHO Essential Medicines List ensure steady procurement from institutional buyers. Indian manufacturers benefit from well-established API supply chains and cost-efficient production capabilities for Itraconazole formulations.

This makes Itraconazole one of the most sought-after molecules for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Tablet
100mg

Frequently Asked Questions

What is the minimum order quantity for Itraconazole?
Minimum order quantity for Itraconazole is Contact us for MOQ — varies by product type. Please contact us for bulk pricing and custom quantities.
What dosage forms of Itraconazole can you manufacture?
We manufacture Itraconazole as: Tablet (100mg).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Itraconazole for export?
Yes. We provide export-ready Itraconazole formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Itraconazole?
We manufacture Itraconazole to IP, BP, USP pharmacopoeial standards.
Third Party Manufacturing

Get Itraconazole made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Blister pack (Alu-Alu), Strip pack, HDPE bottle. Packaging customized to client brand guidelines.

Start Manufacturing Itraconazole Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Itraconazole across all dosage forms. PCD franchise and export orders welcome.

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