Minakem facility in Louvain-la-Neuve, Belgium is is a recognized world leader custom manufacturer for development and commerc ... ialization of Highly Potent APIs (HAPI) requiring production under high containment systems down to OEB class 5, OEL 0.xn--1g-99b / m3 / shift. The site has more than 30 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. The facility is fully GMP compliant and FDA inspected state-of-the-art production site that can also provide full regulatory support including the filing of regulatory dossiers with the health authorities (DMF, CEP). read more