PHARMACEUTICAL SERVICES

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 early development department offers a full range of pharmaceutical services for the formulation development of Rx, Generics or mature molecules (Chemicals or Biologicals) with conventional dosage forms or complex dosage forms including:

  • Preformulation
    • - Active pharmaceutical ingredient characterization
    • - Compatibility studies by differential scanning calorimetry (DSC)
    • - Microscopy
    • - Particles size analysis (Laser Granulometry dry way, liquid way)
    • - Rheology studies
    • - In vitro/ In vivo correlation studies

    Before the formulation work, the characterization of the API is a sensitive step. Whether it is a New Chemical Entity or a mature API, Galenix can help with the characterization and the building up of the Drug Master File (DMF) which is deemed necessary for the final registration process.

    Thanks to a wide range of equipment, highly skilled profesionnals and a network of experts, Galenix can also source the drug substance on its customer's behalf.

    Preformulation is a critical step that can be achieved with very small quantities of API, a few grams, for the first development tests.

    Raw materials for development
    See examples of preformulation equipment
    - Equipment for formulation screening:

    - USP type III dissolutest for high-performance screening of oral forms

    - Frantz cells for testing tests membrane permeation to drug substances and drug products.
    Microscopic powder study See examples of preformulation equipment
    Raw materials for development Franz cell equipment for transmucosal and transdermal technologies Franz cell equipment for transmucosal and transdermal technologies
    - Pro-C-epT: High Shear granulator MI-PRO 250
    - This equipment enables to develop the first formulas with a few grams of API.

    - Mixer Granulator Dryer : ROTOLAB Zanchetta

    - Fluid bed dryer : Glatt
    GLATT fluid bed dryer Rotolab Zanchetta MI-PRO 250
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