Ketoconazole

Ketoconazole is available in BP, EP, USP and IP grades and is supported by CEP documentation, providing regulatory support for customers operating in regulated markets.

The product is manufactured under WHO-GMP compliant quality systems and is supported by ISO certification and valid manufacturing licenses. Applicable EU-GMP Written Confirmation and ANVISA regulatory documentation are also available.

With a manufacturing capacity of 40 MT/month (480 MT/year), we can support both regular commercial requirements and long-term customer supply programs.

Our manufacturing processes focus on consistent quality, robust process control and compliance with applicable international pharmacopoeial and regulatory requirements.