MINAKEM focuses on :
- Synthesis of Starting Materials for the fine chemical industry in dedicated facilities with cost-effective processes.
- Custom Manufacturing of Key Intermediates for the pharmaceutical industry with finishing stages in qualified cGMP plants.
- Manufacture of Active Pharmaceutical Ingredients (API's), niche API's or large-scale API's, patented or generic API's under cGMP guidelines.
MINAKEM offers a wide experience in Process and Analytical Method Development of complex multi-step syntheses, high quality starting materials, intermediates and API's for the pharmaceutical industry under secrecy agreement.
MINAKEM has sufficient capacity and appropriate equipments to complement each step in a drug’s life, from preclinical to commercial and Life-cycle management phase. With over 500 cubic meters of reactors, the production tool is fully flexible and still can manufacture tens to hundreds of tons of a product on a yearly basis.
Every year :
- 100 to 120 different stages of synthesis are developed at the lab scale;
- 60 and 70 stages are synthesised at pilot scale, to produce 10 kg to 100 kg of final product;
- in excess of 80 different products are manufactured at the industrial scale (from 100 kg to 100 tons).
Analytical methods are developed to characterise the molecules and the purity achieved by the processes developed in our laboratory and pilot plants.
Technical documentation for regulatory purpose and drug registration is supplied together with the delivered chemicals.
Minakem is also able to develop the analytical methods and the analytical data required for submitting NDAs or ANDA's.
MINAKEM doesn't focus on the short term profit, but the long-term relationship !
MINAKEM offers responsiveness, flexibility and cost effectiveness of a "human-sized company" to each and every client at a personal level.