The European Union this week posted regulations that upon the U.K.’s exit for the EU its API makers will be treated like those from China and India.

Manufacturing costs are a significant factor in pricing CAR-T cancer meds because of the intensive process required for the personalized treatments.

Women turning to Perrigo’s Option 2 emergency contraceptive may be facing more than one unexpected situation. Some boxes don’t contain the med.

Pfizer's Hospira is recalling one lot of 25% dextrose injection for infants after a customer complained of finding a human hair in a syringe.

Johnson & Johnson is putting behind it the lingering legal problems that stemmed from manufacturing issues that led to recalls some years back.

Earlier this month, the FDA banned all products being shipped to the U.S. by a Chinese API maker, and a new warning letter explains why. It appears the…

The manufacturing problems at Sun Pharma’s key Halol, India, plant have again stymied approval of a new drug from Sun's novel drug development group,…

The FDA has warned Vikshara Trading & Investments for its repeated efforts to keep inspectors from getting a look into its filthy plant.

The FDA has cited an Aurobindo sterile manufacturing plant in India for not doing everything it can to prevent contamination, according to a new report.

India’s Wockhardt saw its losses widen last year as its burgeoning regulatory issues with the FDA continue to chainsaw away at its finances.

Drug Safety