An Akorn sterile drug plant is in hot water with the FDA again, but it may be a problem for Fresenius Kabi, which is buying the generics manufacturer.

A report by the European Medicines Agency lays out the reason why German regulators pulled the GMP certificate from a Dr. Reddy's plant in India.

Still struggling to turn its manufacturing around, Dr. Reddy's is recalling 569,000 store-brand famotidine tablets in the U.S.

Chinese drugmaker Asymchem Laboratories’ API plant in Dunhua successfully passed an inspection by Australian drug regulators for a second consecutive time, the…

In the wake of Hurricane Maria, J&J says the company's Puerto Rico manufacturing plants "fared well," but "intermittent" shortages…

Some generics makers are responding to industrywide pricing pressure by bulking up via M&A. Not Novartis.

iBio, a CDMO that focuses on plant-based biotechnology, said it reached an agreement to support Aethlon Medical with the production of its blood purification…

Sun Pharmaceuticals said the FDA has cleared its manufacturing facility at Dadra that had received a warning letter from the agency earlier this year.