CLINICAL SUPPLIES

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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Clinical batches production
With a wide range of equipment for the clinical trial 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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