Ketoconazole Cream

Ketoconazole Cream belongs to the Creams category within the Anti-Fungal and Dermatology therapeutic segments. It is a broad-spectrum azole antifungal.

Saar Biotech manufactures DCGI-approved formulations of Ketoconazole 2% Cream from our manufacturing facility in Baddi, available in 20gm, 30gm, and 50gm laminated tube formats.

At Saar Biotech, we manufacture Ketoconazole Cream using a precision-controlled homogenization process that ensures every tube delivers uniform API distribution and consistent therapeutic delivery.

• API Uniformity: Homogeneous dispersion of Ketoconazole through the cream base.
• Viscosity Consistency: Ensures easy application and spreadability.
• pH-Optimised Base: Skin-compatible pH range prevents irritation.
• Tube Filling Precision: Automated filling ensures accurate fill weight per tube.

This cream is manufactured by Saar Biotech for the following clinically recognised indications:

• Tinea Pedis (Athlete’s Foot): Fungal infection of the feet
• Tinea Cruris (Jock Itch): Fungal infection of the groin area
• Tinea Corporis (Ringworm): Fungal infection of the body
• Cutaneous Candidiasis: Yeast infections of the skin
• Seborrheic Dermatitis: Dandruff and skin scaling conditions
• Pityriasis Versicolor: Fungal skin discoloration

Ketoconazole inhibits the synthesis of ergosterol, a major component of fungal cell membranes. By inhibiting lanosterol 14α-demethylase, it disrupts cell membrane formation, leading to increased membrane permeability and fungal cell death.

Manufacturing Integrity

• Chemical Stability: Ketoconazole remains stable in the cream base when formulated correctly.
• Preservation System: Validated preservation system maintains microbiological integrity.

Saar Biotech offers Contract Manufacturing services for Ketoconazole Cream from our semi-solid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Semi-solid manufacturing lines with planetary mixer homogenizers and automated tube filling.
• Capacity: Pilot batches to commercial runs of 1,00,000+ tubes.
• Quality Lab: GLP-certified in-house QC with HPLC, pH metres, and viscometers.
• Turnaround: 30–45 working days for new orders; 20–25 working days for repeat partners.
• Packaging: 20gm, 30gm, and 50gm laminated tubes with custom mono-carton.
• MOQ: 5,000–10,000 tubes per SKU.

1. Sealed Tube Storage: Store below 30°C in a cool, dry location away from direct sunlight. Do not freeze.
2. In-Use Handling: Replace the cap firmly after each use.
3. Application Precautions: Apply exclusively to intact skin. Keep away from eyes and mucous membranes.

Every batch is released only after completing the following analytical protocol:

• HPLC Assay: Confirmation of Ketoconazole 2% label claim.
• pH Testing: Verification of pH within skin-compatible specification range.
• Viscosity Testing: Confirmation of batch-to-batch consistency.
• Microbial Limit Test (MLT): Confirms total aerobic count and absence of specified pathogens.
• Certificate of Analysis (COA): Issued with every B2B consignment.

Common Side Effects: Local irritation, redness, itching, burning sensation.

Contraindications: Known hypersensitivity to ketoconazole or any component. Not for use on broken skin, open wounds, or mucous membranes.

Precautions: Avoid contact with eyes. Use during pregnancy and lactation only under physician supervision.

For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Ketoconazole Cream, please use the enquiry form below.