ABOUT US

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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The pharmaceutical development process at Galenix is oriented towards the customer's needs and comply with European and US FDA standards. Quality Assurance teams support all activities, assuring that standard operating procedures are followed and that Good Manufacturing Practices are implemented throughout the project.


GMP Europe and US FDA standards

Certifications for Galenix Pharma :

  • Authorization for cGMP manufacturing, importation and distribution of human medicinal products and investigational medicinal products AFSSAPS # M09/168.
  • Authorization for cGMP manufacturing, importation and distribution of veterinary medicinal products and investigational medicinal products AFSSA # V1515/08.
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