With nearly 30 years’ experience in the contract manufacture of pharmaceutical dosage forms, Unither is ideally positioned to advise and assist its customers in making the selection of the appropriate dosage forms for their needs.
At our sites in France, the USA, Brazil and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs.
To find out more about all our pharmaceutical dosage forms and collaborating with Unither, please do not hesitate to contact us.
Unither specializes in unit and multidoses and can provide dosage forms for an extensive range of applications, such as buccal health, cold and flu remedies, gastroenterology, ophthalmology, pain management, respiratory disease, rhinology, gynecology and wound management. Our dosage form options include Blow-fill-seal (BFS) and liquid stick-pack technologies but can also assist with other traditional dosage forms such as pharmaceutical bottles, sprays. Unither has also developed and patented Uniflash®, an innovative BTM (Buccal Trans-Mucus) systemic drug delivery system that provides an alternative to the use of intravenous solutions.
Unither 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.
We have extensive experience in the development and production of orphan drugs. We work closely with our clients to understand their specific needs and tailor our manufacturing processes accordingly. Our manufacturing process is fully compliant with cGMP regulations, and we have a comprehensive quality control program in place to ensure that each batch of drug is tested and meets all regulatory requirements.
In addition to our manufacturing capabilities, we also offer a range of services to support the development and commercialization of orphan drugs. These services include regulatory support, analytical, full development, formulation and process implementation services. We are committed to working closely with our clients to ensure that their orphan drugs are successfully developed, produced, and brought to market.
