UK CMO Aesica Pharmaceutical says that working with academia to access cutting edge technologies is critical for contractors that want to meet the demands of the modern drug industry.
The GDUFA ‘self-identification’ requirement for generic API plants is not a flawed idea says SOCMA’s BDTF after FDA extends registration deadline citing fewer than expected registrations.
GE Healthcare says new cell science lab in Wales will save drugmakers time and money and create more accurate alternatives to animal-based drug toxicity testing models.
Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.
CMO Synerlab has added lyophilisation and solid dosage form development capabilities to its offering with the acquisition of LyoFal and IDD-Tech Orleans.
A European industry group says EU efforts to ensure the quality of API made by manufactureres outside the region are inadequate and that mandatory inspections of overseas plants are a must.
Fujifilm Diosynth Biotechnologies will manufacture the bulk API for ThromboGenics recently US approved eye treatment Jetrea at its facility in Billingham in the UK.
Lonza says it will cut jobs at its facility in Visp, Switzerland and that it may enact ‘similar productivity improvement programmes’ at other facilities.
The full impact of Superstorm Sandy is still being assessed, but early reports suggest that the East coast contract manufacturing industry has escaped relatively unscathed.
Outsourcing-pharma.com presents a roundup of contract manufacturing news with deals for Lonza, DSM and Ark Therapeutics and an expanded agreement with Shire for AMRI.
US CMO Ben Venue has restarted 'limited drug manufacturing' at its plant in Bedford, Ohio, but does not expect to start shipping product for several months.
SternMaid has invested €14m in its Wittenburg factory to enlarge capacity and extend the range of its products and services, involving the introduction of new fluid bed technology.
Piramal Healthcare wants to add sterile injectables to its offering but is unwilling to overpay for facilities owned by 'value focused' private equity groups.
