CLINICAL SUPPLIES

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

Galenix, with its extensive expertise, experience in formulation and clinical supply, 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 cGMP facilities Galenix Pharma.
Placebo tablets
Placebo capsules
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