CANADA
Montreal
Our Northern American site offers large scale manufacturing capabilities for custom synthesis, small molecules APIs including controlled substances with versatile technologies.
Minakem acquired DELMAR Chemicals Inc in 2023 and we can produce from Canada more than 20 APIs. Our R&D center allows successful new productions of commercial APIs or intermediates for multistep synthesis.
Our team can also offer regulatory filling support for the US, EU, Japan and China.
Key Facts
- Multi-step API process development, manufacturing and analytical development
- Dedicated large scale corticosteroid APIs workshop with OEB 4 containment (OEL up to 1 µg/m3/8h)
- 174 m3 reaction capacity
- R&D Center
- cGMP kilolab and pilot plant
Compliance approvals
Health Canada / FDA / Japan / Korea
Facility Details
Process chemistry development laboratories
R&D analytical development and QC laboratories
Corrosion resistant Kilo lab with 30, 15 and 10 liters reactors and filter dryer in OEB4 (OEL up to 1 µg/m3/8h)
Small scale:
- 8 reactors from 200 to 900 liters glass lined and stainless steel,
- 500 liters Hastelloy® cryogenic reactor,
- filter dryer Hastelloy®
Production capacities:
- 39 reactors from 400 to 7600 liters glass lined, stainless steel or Hastelloy®
- 4m3 cryogenic reactor
- Inverting filter Hastelloy® centrifuges
- Filter dryers from 0.5 to 3 m² stainless steel and Hastelloy®
- Pan dryers stainless steel and Hastelloy®, Double cone dryer Hastelloy® 2m3 – Tray dryer
- Freeze dryer
Licence for controlled substances (level 10, level 6)
Core capabilities
- cGMP custom synthesis and tons scale
- Process transfer, industrialization for commercial scale
- Dedicated workshop for corticosteroids
- Lithiation
- Organometallic reactions (Grignard, Pd coupling…)
- Hydrazine
- Cryo technology (-80°C)
- Hydrogenation
- Freeze drying
- Milling
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