Ubichem is investing in additional production capacity in its facilities in Budapest, Hungary. Four additional 3,000 L reactors (glass and steel) and increased drying capacity are planned to be online in the second half of 2007. This will increase the total output of the plant and support current development projects as they move up in scale.
In further moves to extend manufacturing capacity, Ubichem commissioned a new dedicated cGMP API laboratory in October 2006; this is a validated class 100,000 environment that operates using the concept of single use or dedicated glassware, with single-fluid heating/cooling.
The company also completed the upgrade of its main production unit in August 2006, to full cGMP standard. Since then, four cGMP API campaigns have been completed in support of clinical phases 1 and 2, as well as a new generic – made using process technology developed at Ubichem.
New quality control laboratory facilities also form part of the expansion in Hungary. It is anticipated that these will be operational at the end of March 2007.