Manufacture of orphan drugs

Experience and capabilities

Based on our agile structure and the various capacities of our equipment (ranging from several hundred to several thousand grams or milliliters), we manufacture and package medicines.

We also offer analytical, full development, formulation and process implementation services.

Our flexibility, reactivity and of experience with this type of drug make us an ideal partner.

Clinical batches

CGMP Clinical batches, Phases I, II, III and IV

Over the past 25 years, Unither Développement Bordeaux has acquired extensive expertise in the development and manufacture of medicines in phases I and II. These initial stages are essential and require flexibility and agility in order to start the first clinical trials quickly.

 

Unither Développement Bordeaux manufactures all galenic forms for clinical batches, whether developed by our teams or not. Clinical batch sizes of up to 50 kg of powder or 50 l of liquid.

 

Since product development and clinical batch manufacturing are carried out under one roof, we ensure product scale-up in the same environment, with identical personnel and equipment.

Import of comparators for clinical trials

ANSM (Agence Nationale de Sécurité du medicament et des produits de santé) has granted Unither Développement Bordeaux the status of importer. The company is authorized to purchase, import, control and release drugs as comparators for use in clinical trials from all countries.

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Sites Technologie Unite Min Max
Amiens Solutions / Suspensions Liter 15 300
Coutances Solutions / Suspensions Liter Contact site 2000
Colomiers Solutions / Suspensions Liter 50 1000
Gannat Solutions / Suspensions Liter Contact site Contact site
Bordeaux Solutions / Suspensions Liter 0 50
Bordeaux Poudre / comprimés Kg 0 50
Rochester Solutions / Suspensions Liter 30 2000
Barretos Solutions / Suspensions Liter 50 2000

Regulatory expertise

Production of commercial batches

Analytical development