Dunkerque (FR) – large scale commercial API factory

Dunkerque - our commercial API factory

Key facts

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

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
  • Steroïd-compliant unit: Budesonide
  • “Prazole” synthesis: Esomeprazole, Omeprazole
  • Micronization trains
  • Injectable grades
  • Regulatory filing in the US, EU and Japan (under registration process)

Compliance Approvals

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

Facility Legacy

Minakem Dunkirk is a cGMP manufacturer of key pharmaceutical intermediates and 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

1990:   Construction of the site by Astra (AstraZeneza)

1992:   Start of Omeprazole production in P1

1993:   Start of Budesonide production

1996:   Start of Omeprazole Magnesium in P1

1998:  Start of Esomeprazole Mg in P1

1999:  Merge Zeneca with Astra

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

2009:  Acquisition of the AZ chemical site by Minakem

2009:  Production of Omeprazole Na for injection

2010:  Production of Esomeprazole Na for injection

2012:  CEP Budesonide and Omeprazone Minakem approved by EDQM

2013: FDA inspection – No 483 / Last ANSM inspection, Validation campaign for 3 new products (Lacosamide 2G,   XX and YY)

2014: CEP Esomeprazole  Mg•3H2O Minakem approved by EDQM

2015: US DMF Budesonide (NDA / Salix Pharmaceuticals)

CEP Esomeprazole  Mg•2H2O Minakem approved by EDQM

2016:  FDA inspection

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 26mproduction volume. In total, the production volume at the Dunkirk site will increase by 54m3 to a total capacity of 148 m³

 

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