Minakem is a fully integrated commercial manufacturer of Active Pharmaceutical Ingredients (APIs) with R&D capabilities to develop and transfer the manufacturing process to one of its four API facilities in Europe or Canada.”

  • API manufacturing (Innovators, Generics, including Steroids and Highly Potent)
  • Custom development (process development and optimization)
  • Custom manufacturing
  • Production of key intermediates and building blocks

 

All development and manufacturing activities are supported by highly skilled R&D technical centres,  strong and state-of-the-art analytical services including solid form and QbD laboratories.
Regulatory Affairs department is supporting the registration of the dossiers in USD, Europe, Japa, Korea, China, etc…

MINAKEM’s talented team also ensures high-quality services in Quality Assurance, Regulatory Affairs, Safety, Health and Environment (SHE).

Minakem is a technology-driven company with expertise in complex multi-step synthesis, high potents, pressure chemistry, chiral synthesis, low temperature for suzuki coupling, halogenation and lithium chemistry, steroid chemistry and “prazole” chemistry…

Minakem has operations in 4 different API development and manufacturing sites, which are all approved by the U.S. FDA and local health agencies :

  • Dunkirk, France – former AstraZeneca “prazoles” and budesonide (steroid) API production site
  • Beuvry-la-Forêt, France
  • Louvain-la-Neuve, Belgium – former Ajinomoto-Omnichem site, specialized in high potents APIs, HPLC purification and vinca alkaloids synthesis
  • Montréal, Canada – small molecules API manufacturing, including steroids

Strong synergies within MINAKEM offer customers the flexibility, responsiveness, and cost-effectiveness paired with the strong technical know-how to create significant added value within our customers’ supply chains. OTIF above 97% is an internal target assigned by the top management.

Minakem is an affiliate of the MINAFIN Group and as such has access to all technologies, resources, and capabilities to respond to its client’s needs, especially with Minascent technologies (Leuna, Germany), and Pennakem (Memphis, TN, USA).

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