Synkem S.A.S.


Managing Director:

Yves Michon


Synkem S.A.S.

47, rue de Longvic
B.P. 50
21301 Chenôve Cedex
France
Phone:+33 380 447 272
Fax:+33 380 447 270

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Core Capabilities

  • NCE cGMP custom synthesis from kilolab to multi tonne scale
  • Multi-step API process development, manufacturing and analytical development
  • Industrialization from feasibility to commercial scale
  • Regulatory filing in the US, EU and Japan
  • Pharmaceutical establishment in production of bulk pre-mixed drug products

CordenPharma Chenôve Facility Capacities

Compliance Approvals

  • US FDA – 2014
  • ANSM – 2013
  • PMDA – 2012

Facility Legacy

Synkem is a cGMP manufacturer of advanced pharmaceutical intermediates and APIs specializing 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 multistep synthesis.

As a former facility of Solvay Pharmaceuticals, Synkem brings over 25 years of experience and expertise in pharmaceutical chemistry, technology, project management and registration processes to CordenPharma’s full-service CMO platform.

History

  • 1960 MSD facility
  • 1985 Facility purchased by Fournier Laboratories
  • 1995  First FDA inspection
  • 2005 Fournier Laboratories taken over by Solvay Pharmaceuticals
  • 2008 Synkem acquired by ICIG