The FDA has slapped a warning letter on a Chinese company that shipped multiple lots of an OTC product to the U.S. that contained the wrong API.
Biocon has seen its earnings hit by FDA and EU regulatory issues at its Indian plant that makes the biosimilars it and partner Mylan have developed.
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
Merck KGaA and South Korea’s Samsung BioLogics are deepening a collaboration even as Samsung reported an operating profit for the first time.
Shire intends to take some manufacturing of its rare disease drug Cinryze in house after problems with a contractor led to a shortage of the drug.
India-based API maker Vital Laboratories was slapped with a warning letter from the FDA over manufacturing and records issues at its Plant II located in Vapi,…
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.
Some generics makers are responding to industrywide pricing pressure by bulking up via M&A. Not Novartis.
AbbVie began the next phase of its Singapore manufacturing expansion with a new biologics unit that complements the plant's existing API production.
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.