Ubichem Approved for cGMP Radiolabelled API Production
Jozsef Repasi, Managing Director of Ubichem Research commented:
"This approval enables us to supply radiolabelled materials for use in human clinical trials, and is a reflection of the skill and hard work of our dedicated team in Budapest, building on the approval obtained previously for the commercial supply of cGMP APIs."
The Ubichem isotope synthesis group has vast experience in the synthesis of labelled compounds for use by pharmaceutical and biotech companies in pharmacokinetic and metabolic studies, and will now be able to meet their needs for use in clinical trials too.
Ubichem was founded in 1978 to offer competitive sourcing solutions for fine chemicals and intermediates to clients in hightechnology industries, and these activities continue today through the Fine Chemicals Division.
Ubichem Research was created in 1996 in Budapest, Hungary, and through the Pharma Services Division, provides a comprehensive range of chemistry services (on lab to pilot plant scale) to support early pharmaceutical development. These include cGMP API and intermediate manufacture, process research and development, analytical method development and validation, and radiolabelling.