EMA adds Q&A on genotoxic impurities & residual solvents
The EMA has updated its quality documents with sections on genotoxic impurities, residual solvents, and heavy metal catalyst residues.
Archives for June 25, 2012
Quotient & Capsugel partner on lipid formulation services
Quotient and Capsugel have teamed up to tackle drug delivery challenges in lipid-based formulations with new assessment and development services.
New filtration tech boosts biomanufacturing yields, says Sartorius
Sartorius Stedim says its new range of sterilising-grade filters can allow steam cleaning in dry conditions and minimises protein binding.
FDA says Amylin withheld data on extended-release drug
The FDA has accused Amylin of withholding cardiac safety information in its marketing application for an extended-release diabetes drug.
Amag to embrace outsourcing and close plant to cut costs
Amag Pharmaceuticals is selling its manufacturing plant and cutting 45 positions as it moves to an outsourced model to save cash.
Roowin takes over old Schering-Plough plant, boosts small scale GMP services
Roowin says it will be one of the first small batch GMP makers for Phase I & II clinical trials after moving into a new facility in Riom, France.