Ketoconazole API Manufacturer & Supplier in India

Ketoconazole is an imidazole antifungal agent used topically for dermatophytosis, seborrheic dermatitis, and tinea infections. Systemically it inhibits fungal ergosterol synthesis and adrenal steroidogenesis. Mediocon Inc supplies high-purity Ketoconazole API meeting IP/BP/EP/USP standards for cream, shampoo, and tablet formulations.

Key Features

• Broad-spectrum imidazole antifungal
• IP/BP/EP/USP compliant quality
• Suitable for topical and systemic formulations
• Low impurity profile for dermatology use

Applications

• Dermatophytosis and tinea infections
• Seborrheic dermatitis and dandruff shampoo
• Candidiasis (mucocutaneous)
• Cushing's syndrome (off-label systemic use)

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Ketoconazole (CAS 65277-42-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ketoconazole is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

• USA — FDA-registered facility; DMF support available for ANDA/NDA filings
• Europe — EMA-compliant documentation; CEP/EDMF support on request
• Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
• Southeast Asia — established logistics network; temperature-controlled shipments
• India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• GMP-certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability from raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries