Nottingham, UK-based Juniper Pharma Services (formerly Molecular Profiles), has been granted permission by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture and supply bulk unlicensed medicines.
This allows the contract development and manufacturing organisation (CDMO) to produce tablets, capsules and other solid oral dosage forms intended for use as unlicensed medicinal products (more commonly known in the UK as Specials).
Under the licence, Juniper Pharma Services intends to manufacture and supply certain non-sterile medicines in bulk required by Specials suppliers.
Claire Madden-Smith, VP Commercial Services at Juniper Pharma Services, said: 'Many Specials producers and wholesalers in the UK do have in-house manufacturing capabilities but these are often restricted to producing one-off medicines for patients.
'As a result, these companies often require an outsourced manufacturing partner like Juniper Pharma Services to produce certain medicines in bulk supply on their behalf to help overcome capability restrictions, reduce unit costs and help maintain required stock levels.
'This Specials licence therefore allows the company to meet such market needs from our manufacturing facility.'
Juniper Pharma Services' move into the Specials market is a natural extension to the company’s clinical manufacturing capabilities, which are focused on delivering product supply for small scale early trials up to Phase III and beyond.
