MINAKEM High Potent
- 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).