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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All kinds of dosage forms are developed at Galenix, from the most simple to the most sophisticated.
Patented Drug Delivery Systems developed by Galenix may also improve or modify the drug product's features in order to respond to special requirements (slow, fast release, enhanced bioavailability...)

Here is an overview of our know-how in formulation :

Solid dosage form :
    - Immediate release, modified release, sustained release tablet
    - Multilayer tablet, coated tablet
    - Powders and granules for reconstitution
    - Capsules
Semi -solid and liquid dosage form :
    - Solution, suspension, gel (aqueous or lipidic base)
    - Liposomes, microemulsions, emulsion
    - Transdermal therapeutic systems

Development of comparator :
    - Matching placebo
    - Over encapsulation
    - Film coating

Taste masking


Process transfer and scale-up of drug product


Formulation Equipements :
    - MR6 FROGERAIS tablet press equipped with sensors
    - Alternative press : Korsch EKO with sensors and data acquisition
    - OA FROGERAIS press equipped with sensors
    - BSI/roue Rhoen mixer
    - BMG Böhle (50 g - 1 kg) mixer granulator
Korsh EKo tablet press MR6 Rotative tablet press
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