An FDA inspection of a Biocon API plant in Bangalore found a number of issues, but the Indian drugmaker shrugged it off in a statement essentially saying, this…

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.

FDA inspectors continue to roll through Dr. Reddy’s plants in India and continue to find issues along the way.

The FDA, which banned APIs coming from a Divi’s plant in India, has followed that with a warning letter that savages the facility for a lack of data integrity.

For nearly two years Teva struggled with impurity issues for an API manufactured at a plant in China.

Swiss CDMO Lonza, which has run into FDA concerns about its FDA operations before, has had its cell therapy facility in the U.S. slapped with a warning letter.

French regulators have warned the European Medicines Agency (EMA) that a sterile manufacturing operation in Brazil has some significant problems and its…

Regulatory