Dunkerque – small molecule factory for large volumes API and steroid API

Dunkerque - our commercial small molecule factory for large APIs and steroid API

Key facts

150m3 reaction volume (an additional 28m³ in development)

KEY PRODUCTS

  • Esomeprazole
  • Omperazole
  • Budesonide

Core Capabilities

  • cGMP custom synthesis and generics multi-ton scale
  • Dunkirk (FDA-approved) for large-scale API’s and repeat productions
  • Organic synthesis 2-4 steps, up to 300 tons for repeat commercial APIs
  • Stereoselective syntheses
  • Dedicated Steroïd unit: Budesonide
  • “Prazole” synthesis: Esomeprazole, Omeprazole
  • Micronization trains
  • Injectable grades
  • Regulatory filing in the US, China, EU and Japan

Compliance Approvals

  • FDA (USA) – 2018
  • ANSM (France) – 2017
  • PMDA (Japan) – 2016

Facility Legacy

Minakem Dunkirk is a cGMP manufacturer of small molecules APIs.  This site specializes in the design of synthetic routes and development processes for new products from laboratory to commercial scale with equipment and chemical technologies that are particularly suitable for multi-step synthesis. Minakem Dunkirk brings over 28 years of experience and expertise in pharmaceutical chemistry, technology, project management, and registration processes.

History

2022: First Chinese DMF for budesonide granted

2018: A €14.5M investment to increase production capacity by 28m3. In parallel, existing production assets are being upgraded in order to increase flexibility. This will free up an additional 26m3 production volume. In total, the production volume at the Dunkirk site will increase by 54m3 to a total capacity of 148 m³

2015: US DMF for Budesonide (NDA / Salix Pharmaceuticals) and CEP for Esomeprazole  Mg•2H2O approved

2014: CEP for Esomeprazole  Mg•3H2O

2013: Validation campaign for 3 new products (Lacosamide 2nd Generation)

2012:  CEP for Budesonide and Omeprazole

2010:  First production of Esomeprazole Na for injection

2009:  First production of Omeprazole Na for injection

2009:  Acquisition of the Astra Zeneca chemical site by Minafin Group that became: “Minakem Dunkerque”

2003:  P2 – New production building in operation for Esomeprazole Mg

1998:  Start of Esomeprazole Mg production in P1

1996:   Start of Omeprazole Magnesium in P1

1993:   Start of Budesonide production

1992:   Start of Omeprazole production in P1

1990:   Construction of the site by Astra (now Astra Zeneca)

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