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Successful Sterile Inspection for Scottish CMO

Symbiosis has been re-inspected and approved for the ongoing production of IMPs for clinical trials

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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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