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Symbiosis has been re-inspected and approved for the ongoing production of IMPs for clinical trials
August 10, 2015
By: Tim Wright
Injectable manufacturing specialist Symbiosis Pharmaceutical Services has successfully completed a scheduled inspection from the UK Government Regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The contract manufacturing organization (CMO) received no critical or major observations. Symbiosis has been re-inspected and approved for the ongoing production of investigational medicinal products (IMPs) for clinical trials. In a further boost to support the growth and strategic development of the company, it received confirmation of continued authorization for the GMP-manufacture of aseptically filled licensed commercial products following initial approval of the commercial manufacturer/importer (MIA) license last year. The regulatory inspection and approval of Symbiosis’ Scotland-based facility comes in the wake of several high profile pull outs and inspection failures at sterile pharmaceutical manufacturing facilities globally.
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