The site will be used for the supply of licensed commercial products and to complement its clinical manufacturing facility
SCM Pharma has received MHRA approval for commercial production at its new manufacturing facility
The UK’s Medicines and Healthcare products Regulatory Agency has given SCM Pharma’s new £6m ($10m) contract manufacturing facility the go-ahead for commercial production following a successful inspection.
The UK-based contract development and manufacturing organisation (CDMO) will use its new 26,000ft2 site for the supply of licensed commercial products and to complement its nearby clinical manufacturing facility for projects requiring clinical scale-up.
Based in Newburn, Tyne-and-Wear, the site is able to handle highly potent, flammable and toxic products along with controlled drugs. It houses technology for aseptic filling and terminal sterilisation capabilities and is equipped for ampoule filling, vial filling and syringe filling.
Dianne Sharp, Managing Director at SCM Pharma, said: ‘The official MHRA approval of our new facility is a huge landmark in the history of our company and heralds in a new era for our team.
‘We are planning an event to officially open the doors this summer before Newburn becomes a hub for the production and supply of licensed drug products to help patients across the world.’
SCM Pharma specialises in the sterile production of drug products that require high containment.