MINAKEM
https://www.minakem.comLouvain-la-Neuve, Mont-Saint-Guibert, B-1435
Belgium
Categories
About MINAKEM:
MINAKEM IS A FULLY INTEGRATED DEVELOPMENT PARTNER AND COMMERCIAL MANUFACTURER OF APIS FOR PHARMACEUTICAL COMPANIES
Custom development (process development and optimization)
Custom Manufacturing
API manufacturing (Innovators, Generics and Highly Potent)
Production of key intermediates and building blocks
All development and manufacturing activities are supported by highly skilled R&D technical centers, and strong and state-of-the-art analytical services, including solid form and QbD laborator...ies.
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, halogenation and lithium chemistry, steroid chemistry and “prazole” chemistry…
Minakem has operations in 4 different development and manufacturing sites, which are all approved by the U.S. FDA and local health agencies :
Dunkirk, France – former AstraZeneca “prazoles” and budesonide 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 manufacturing, including steroids
Service Offerings:
- High Potent Manufacturing
- Analytical Services
- Particule Design Engineering
- Route scouting
- Process Development
- Process Optimization and scale-up (early to late stage. small to large scale)
- Risk management
- Clinical batch supply
- cGMP (FDA) and non-GMP routine production
- Analytical Process validation and Optimization
- Synthesis and purification of analytical reference standards and impurities
- Quality by Design (QBD)
- ICH stability studies
- Safety and toxicology assessments
- Regulatory support
- Supply chain