CLINICAL SUPPLIES

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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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Clinical batches production
With a wide range of equipment for the manufacturing (high shear granulators, compactor, tablet machines for mono, bi or three layer tablets, Fluid beds, compactor, Drum coater, blenders…), Galenix Pharma is entitled to manufacture solid, liquid and semi-solid dosage forms.


Solid dosage form (1 to 200kg) :
    - Immediate release, modified release, sustained release tablets
    - Multilayer tablets
    - Coated tablets
    - Capsules : powders, granules, pellets, tablet
    - Sachets
    - Product for comparator studies : matching placebo, over encapsulation, film coating and sugar coating

Liquid and semi-solid dosage forms (max 500 l):
    - Solutions, suspensions, emulsions
    - Gels, creams
Weighing booth with lamina flow
BSI Blender
- BSI blenders :
2,5 l, 10 l, 15 l, 75 l, 150 l, 250 l, 500 l

- Roue Rhoen blender TE 650 :
3 l, 5 l, 10 l, 20 l, 30 l, 35 l
- Fluid bed dryers :
  Vector FLN 30
  Glatt GPCG1
- Wet granulation :
  Colette Gral 75
  Aeromatic Fielder PMA 1
  Lödige M5R, M20R, FM50

- Dry granulation :
  Roller compactor Alexanderwek WP120

- Coating :
  Hi-Coater Vector VHC1355
Alexanderwerk WP120
Vector FLN 30 Colette Gral 75
Killian S100 Hi Coater Vector VHC 1355
Bosch GKF 400
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