Selcia Limited is pleased to announce that its radiochemistry facility has been granted a Good Manufacturing Practice (GMP) certificate for the preparation of C-14 labeled Active Pharmaceutical Ingredients (APIs)
Ongar, Essex, United Kingdom (7 December 2010). Selcia Limited, a leading independent provider of Carbon-14 (C-14) radiolabelling services, is pleased to announce that its radiochemistry facility has been granted a Good Manufacturing Practice (GMP) certificate for the preparation and C-14 labelling of Active Pharmaceutical Ingredients (APIs) for clinical trials following a successful inspection by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Commenting on the award, Selcia’s Managing Director, Dr Hans Fliri said: “With market demand increasing for GMP radiolabelling, we are pleased that we can now offer pharmaceutical and biotech companies cost effective radiolabelling services to support both the pre-clinical and clinical development of their new medicines. Selcia’s extended capability of now being able to produce GMP radiolabelled API material will shorten the timeframe for our clients to commence key Phase 1 clinical trials”.
Director of Radiochemistry Dr Gill Little said: “Our radiochemistry team continues to focus on delivering the best possible tailored service. Together with our GLP analytical laboratory we can supply the high quality products that our customers expect”.
Selcia is a privately held company providing both C-14 radiolabelling and integrated drug discovery services, operating from a modern facility in Ongar, Essex, UK. The analytical laboratory has been GLP certified for several years.
Selcia’s radiolabelling division produces C-14 radiolabelled compounds for a global customer base encompassing both the life sciences and chemical industries. Applications of the radiolabelled products prepared by Selcia include: preclinical and clinical drug metabolism studies; mass balance, microdosing, research and regulatory studies of cosmetic products; and environmental fate studies of agricultural and industrial chemicals.
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