PHARMACEUTICAL SERVICES

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3rd - 6th MAY 2010
BIO 2010 CHICAGO - USA

LAST NEWS
Nov 2009 - DSM/Galenix strategic alliance

Galenix out-licenses drug delivery technologies to DSM Pharmaceutical Products and forms in a strategic alliance : Galenix today announced that it has out-licensed six drug delivery technologies to DSM Pharmaceutical Products, Parsippany, USA. Galenix and DSM have also agreed on a manufacturing alliance, where DSM will be the preferred commercial scale manufacturing partner for Galenix commercial products on a global basis. Galenix and DSM will collaborate on business development opportunities co-marketing the technologies based on the strength of Galenix in drug product development and clinical services, and DSM in process development, industrial scale up and commercial pharmaceutical manufacturing.
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

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Galenix supports any required testing of product upon importation into the Europe along finished product, release and stability testing with Quality control and QP release and :

  • Provides accurate analytical data to support development
  • Develops and validate analytical methods
  • Supplies analytical transfer protocols
  • Offers wide range of technics and equipment:
    • - Automated equipment Zymark for preparartion and for In vitro dissolution
      - HPLC
      - GC
      - NIR (identification and assay)
      - In vitro dissolution


    A large technologies platform located at our European and US FDA GMP facilities enables to perform all the quality control work on:

    - CTM batches
    - Pilot batches
    - Commercial batches
    - Imported medicines
    ANALYTICAL LABS
    Zymark TPWII samples preparator
    - 19 HPLC Alliance Waters, Agilent, GC

    - 13 dissolutests UV/Visible on line, off line

    - IR spectrophotometer Perkin Elmer Nicolet 380 and
    NIR spectrophotometer Perkin Elmer :
      Nicolet Antaris II and Nicolet Antaris target

    - 2 automated dissolutests Multidose Plus Zymark-Vankel

    - 2 automated equipment for samples preparation Zymark TPWII

    - Karl-Fisher Titrino with Metrohm sampler

    - Potentiometer Mettler Toledo

    And more ...
    Karl-Fisher Titrino with Metrohm sampler
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