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news.Selcia Limited has said 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).
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Selcia managing director Hans Fliri said that they 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," Fliri said.
Selcia Radiochemistry director Gill Little said that together with the GLP analytical laboratory we can supply the quality products that the customers expect.