Clotrimazole API Manufacturer & Supplier in India

Clotrimazole is a broad-spectrum imidazole antifungal agent that inhibits ergosterol synthesis in fungal cell membranes. It is used topically for skin, nail, and vaginal fungal infections caused by Candida, dermatophytes, and Tinea species. Mediocon Inc supplies pharmaceutical-grade Clotrimazole meeting IP/BP/EP/USP standards.

Key Features

• Broad-spectrum imidazole antifungal
• IP/BP/EP/USP compliant, Assay 99.0% Min.
• Effective against Candida and dermatophytes
• Suitable for cream, powder, solution, and vaginal tablet formulations

Applications

• Tinea pedis, cruris, and corporis cream
• Vaginal candidiasis pessaries and cream
• Oral candidiasis lozenges / troches
• Antifungal powder and solution formulations

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 Clotrimazole (CAS 23593-75-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Clotrimazole 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