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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indentification user
MINEXTAB tablet with a floating phase
- Gastro-retentive dosage form
- Narrow absorption : upper gastro-intestinal tract
- Excipients listed in Rx list, USP, EP
- Conventional manufacturing process and equipment