PHARMACEUTICAL SERVICES

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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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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