Ubichem Approved for cGMP Radiolabelled API Production

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Monday, 31 May 2010 10:00 (UTC + 2)

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Eastleigh, UK and Budapest, Hungary, May 31, 2010 / b3c newswire / - Ubichem, a leading 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.

 


About Ubichem - www.ubichem.com

Ubichem was founded in 1978 to offer competitive sourcing solutions for fine chemicals and intermediates to clients in high-technology 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.

 


For more information please contact:
József Répási, Ubichem Ltd.
Illatos Street 33, Budapest, H-1097 Hungary
Tel: +36 1 347 5060
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