Unither is the worldwide leader in sterile unit-dose production using Blow-fill-seal (BFS) technology. Through our sites in North America, Europe and China, we can manage the development of a BFS product from concept to manufacturing, providing the benefit of our development expertise and market intelligence.
The BFS technology employed by Rochester site allows for precise filling of vials, accommodating volumes ranging from 0.25 to 4mL. This flexibility in filling capacity makes it suitable for a wide range of pharmaceutical applications. Unither Rochester's BFS vials are specifically tailored for various pharmaceutical formulations, including solutions, suspensions, gels, and emulsions.
Thanks to our constant and sustained investment in new high-speed BFS lines, our large manufacturing capacity allows us to take on new projects of any size at any time.
Unither’s Blow-Fill-Seal teams handle the technology transfer of products developed by our customers or by third parties. They can also handle the complete development of customised drugs or medical devices. Thanks to its dedicated and highly qualified on-site R&D teams and specific pilot workshops, Unither has the know-how, equipment and expertise to manage product development from the earliest stages.
The Rochester site is inspected by the FDA (Food Drug and Administration), DEA certificate, as well as: Turkish Ministry of Health, MHA (Mexico City), ANVISA (Brazilian agency) EMA (European agency), MHRA (UK) and “Health Canada“, etc.
All sites are regularly inspected by European authorities in order to be able to supply products to European markets. One European site and the US site are inspected and accredited by the FDA (USA) in order to supply the US market. These sites are also inspected by ANVISA (Brazil), SKFDA (South Korean FDA), EMA (Europe) and other health authorities around the world.
Total capacity: 5 billion unit doses/year
Rochester, NY, Etats-Unis
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