Welcome to MINAKEM High Potent

 

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  • More than 40 years experience in Highly Potent compounds
  • High containment systems down to OEB class 5, OEL < 0.1μg / m3 / shift
  • FDA, GMP and EHS full compliance (last FDA audit in Sept 2015 – no 483)
  • Broad range of chemical expertise both on site and in the MINAFIN worldwide network of Fine Chemicals R&D laboratories and plants

 

Minakem High Potent (MHP) is a recognized world leader custom manufacturer for development and commercialization of Highly Potent APIs (HAPI) requiring production under high containment systems down to OEB class 5, OEL < 0.1μg / m3 / shift.

The site has more than 40 years of experience in serving global pharmaceutical companies in handling HAPI and cytotoxic compounds from process and analytical development within our R&D labs, scale-up and production, with manufacturing setting and capacity from grams to hundred kgs following customer requirements.

MHP is a full GMP compliant and FDA inspected production site that can also provide full regulatory support including the filing of regulatory dossiers with the health authorities (DMF, CEP).

 


Quality records

Minakem High Potent is fully compliant with industry quality standards, manufacturing practices and safety, health and environment protection legislations.