Ubichem Approved for cGMP Radiolabelled API Production
News Jun 01, 2010
Ubichem, a provider of chemistry services to the drug development sector, through its Hungarian operation – Ubichem Research - has successfully completed a regulatory inspection and is now approved for the supply of cGMP radiolabelled Active Pharmaceutical Ingredients (APIs).
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.