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.

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