US FDA publishes Akorn Pharmaceuticals' Form 483
The US FDA has identified quality control problems at a sterile drug manufacturing facility operated by Akorn Pharmaceuticals.
Archives for October 18, 2016
CordenPharma completes API process bay for category 4 compounds
This week CordenPharma announced the completion of its new highly potent API process bay for category 4 compounds.
Merck completes expansion of Madrid Gonal-f API plant
Merck has completed the expansion of its biologics API manufacturing facility in Madrid, Spain increasing production capacity by 50%.
Second Form 483 for Montana Compounding Pharmacy in two years
US FDA inspectors found vermin in drug production areas at a manufacturing facility operated by Montana Compounding Pharmacy.
Almac discovers novel immune response mechanism
Almac Group’s Diagnostics business will engage with pharma to validate the link between its immune response assay and checkpoint inhibitor based therapy.
Samsung Bioepis contracts Catalent to help commercialize Benepali
Samsung Bioepis has contracted Catalent to provide fill finish services for its Enbrel (etanercept) biosimilar, Benepali.