ABOUT US

meet us at
Oct. 25th - 27th - 2011
CPHI Frankfurt - Germany
March 12th - 15th - 2012
DCAT New York - USA

LAST NEWS
2011 - Certificate of GMP compliance of a Manufacturer for Human investigational medicinal product

2011 - Certificate of GMP compliance of a Manufacturer for Human medicinal product

MAA CESSION & TRANSFER
Licensing-out opportunity Cetirizine 10 mg/ml, oral solution (NL33352)
NEW MAA CESSION & TRANSFER
Licensing-out opportunity Donepezil 5 mg, ODT (NL37771) and Donepezil 10 mg, ODT (NL37772)
2009 - cGMP Agreement for human use

Galenix Pharma has obtained an updated agreement for cGMP manufacturing, importation and ditribution of human and investigational medicinal products AFSSAPS #M09/168
2008 - cGMP Agreement for veterinary use

Galenix Pharma has obtained an agreement for cGMP manufacturing, importation and distribution of veterinary and investigational medicinal products AFSSA #V1515/08
MAA CESSION & TRANSFER
Licensing-out opportunity Fenofibrate 67 mg, tablet (NL27271) - Fenofibrate 200 mg, tablet (NL27274) and Fenofibrate 160 mg, modified release tablet (NL31360)

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  • Founded in 1993
  • 100% privately owned
  • CEO and main shareholder: Mr Jerome Besse
  • 60 employees
  • Turn over 2008: 13.8 MEuros
  • Three entities:
    • - Galenix Innovations
    • - Galenix Pharma
    • - Galenix Inc.
Services provided to health and biotech companies:

  • Patented Drug Delivery Systems for licensing out
  • Preformulation Products Registration Files for licensing out
  • Formulation development
  • Analytical development and validation
  • Quality Control
  • Stability studies
  • Clinical/pilot batches manufacturing and packaging
  • Clinical packaging and distribution
  • Regulatory affairs
  • Board of Directors and Scientific Advisory Board:
    Jerome BESSE Legal Representative jbesse@galenix.fr
    Celine PULON Pharmaceutical Affairs Director cpulon@galenix.fr
    Nicolas MOINAUX Chief Financial Officer nmoinaux@galenix.fr
    Marie-Laure LEICHTNAM Plant Director (Ad Interim) - QP mlleichtnam@galenix.fr
    Laurence BESSE Pharmaceutical R&D Director lbesse@galenix.fr
    Facts:
  • CA = 13.8 M €
  • Services :
      - Drug Product Development
      - Drug Delivery Solutions
      - Clinical supply services



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