Antifungal

KetoconazoleThird Party Manufacturing in India

Looking to get Ketoconazole 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
65277-42-1
Drug Class
Imidazole antifungal
Molecular Formula
C₂₆H₂₈Cl₂N₄O₄
Molecular Weight
531.43 g/mol
Grade Standards
IP, BP, USP
Therapeutic Category
Antifungal
MOQ
10,000 tubes/bottles per batch
Dosage Forms
Cream, Shampoo, Soap

Mechanism of Action

Ketoconazole works by inhibiting the synthesis of ergosterol, which is an essential structural component of fungal cell membranes. It selectively targets and binds to the fungal enzyme lanosterol 14α-demethylase, a cytochrome P450-dependent enzyme responsible for converting lanosterol into ergosterol.

By coordinating its nitrogen atom with the heme iron of this enzyme, Ketoconazole halts the demethylation process. This leads to the accumulation of toxic 14α-methylated sterols and depletion of ergosterol, causing a severe increase in cell membrane permeability. This structural instability results in the leakage of vital intracellular components, effectively inhibiting fungal replication (fungistatic effect) or leading to fungal cell death (fungicidal effect) depending on the concentration.

Unlike modern triazoles, Ketoconazole is a broad-spectrum imidazole that also exhibits activity against certain gram-positive bacteria and lipophilic yeasts. It is highly effective and well-tolerated for treating superficial skin infections like seborrheic dermatitis, dandruff, and tinea corporis.

Therapeutic Uses & Indications

Therapeutic Uses

Ketoconazole is prescribed for the treatment of:

  • Seborrheic Dermatitis and Dandruff: Controls the overgrowth of Malassezia yeasts on the scalp and skin, reducing flaking, redness, and itching.
  • Tinea Corporis and Tinea Cruris: Treats ringworm and jock itch caused by dermatophytes such as Trichophyton rubrum.
  • Tinea Pedis (Athlete's Foot): Resolves fungal infections on the feet, especially between the toes.
  • Cutaneous Candidiasis: Clears skin yeast infections caused by Candida species.

Why Manufacturers Choose Ketoconazole

Ketoconazole is one of the most commercially successful and widely recognized antifungal agents globally. It is formulated into a variety of high-demand topical products, including shampoos, creams, and soaps. For third-party manufacturers, Ketoconazole is an attractive active ingredient due to its well-established manufacturing process, excellent stability profile in diverse bases, and strong market demand across both prescription and OTC channels.

This makes Ketoconazole a key molecule for third party manufacturing in India, with consistent demand from dermatology brands, PCD franchise networks, and international buyers looking for high-quality topical formulations.

Dosage Forms We Manufacture

Cream
2% w/w
Shampoo
2% w/v
Soap
1% w/w · 2% w/w

Frequently Asked Questions

What is the minimum order quantity for Ketoconazole?
Minimum order quantity for Ketoconazole is 10,000 tubes/bottles per batch. Please contact us for bulk pricing and custom quantities.
What dosage forms of Ketoconazole can you manufacture?
We manufacture Ketoconazole as: Cream (2% w/w); Shampoo (2% w/v); Soap (1% w/w, 2% w/w).
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 Ketoconazole for export?
Yes. We provide export-ready Ketoconazole 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 Ketoconazole?
We manufacture Ketoconazole to IP, BP, USP pharmacopoeial standards.
Third Party Manufacturing

Get Ketoconazole 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

Laminated tube, Aluminum collapsible tube, Bottle (for shampoo), Mono carton. Packaging customized to client brand guidelines.

Start Manufacturing Ketoconazole Today

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

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