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Services
Clinical batches & Orphan drugs
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 |