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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Double-blind clinical trials may require a placebo form to compare with the active drug product.

Galenix, with its extensive know-how in formulation, can copy any conventional dosage form in regards with shape, color and taste.

ICH Stability studies are implemented in the primary packaging in order to verify that the placebo still compares to the genuine drug product over the time.

After stability studies, Galenix production team manufactures the placebo form at its Europe and US FDA GMP facilities Galenix Pharma.
Placebo tablets
Placebo capsules
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