FRANCE
Dunkerque
Our Dunkerque site offers world class large-scale manufacturing capabilities for custom synthesis and small-molecules APIs.
Minakem acquired AstraZeneca’s former API plant in Dunkirk and since 2009, the favourable proximity to Beuvry-la-Forêt R&D centre has allowed successful new production of commercial APIs or intermediate volumes for multi-step synthesis.
Our team can also offer regulatory filling support for the US, EU, Japan and China.
Key Facts
- Two separated production facilities with redundant utilities
- Dedicated steroid workshop
- 121 m3 reaction capacity
- State-of-the-art, fully automated API facilities
- High flexibility for capacity extension
Compliance approvals
FDA / ANSM (EU/France) / Japan
Facility Details
Production capacities:
- 42 reactors from 1200 to 8000 litres glass-lined, stainless steel or Hastelloy®
- Hastelloy® centrifuge
- 32 filter dryers from 0.8 to 6 m² stainless steel and Hastelloy® in ISO 8 isolation suites
- Delumping and micronisation jet milling
- Recycling of solvents
QC Lab
Core capabilities
- cGMP custom synthesis and multi-tons scale
- Process transfer, industrialization for commercial scale
- Continuous process improvement
- Chlorination
- Stereoselective synthesis
- Injectable APIs
- Lithiation
- Organometallic reactions
- Cyanidation
- Solvent recovery
Dunkerque – France
Commercial production of small molecule APIs
- Large scale manufacturing
Montreal – Canada
Development and commercial production of small molecule APIs and Steroids
- Fit for purpose process and analytical development with timely and robust scale-up from clinical to commercial supply
- Dedicated steroid manufacturing unit
Louvain-la-Neuve – Belgium
Development and commercial production of small molecule Highly Potent APIs (HPAPIs) and Steroids
- Fit for purpose process and analytical development with timely and robust scale-up from clinical to commercial supply
- OEL: 0.1µg/m3/shift and Industrial Preparative HPLC
Beuvry-la-Foret – France
Development and commercial production of small molecule APIs
- Fit for purpose process and analytical development with timely and robust scale-up from clinical to commercial supply
- Home to Minakem’s R&D Center of Excellence