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.

A recent report says that FDA inspections of Indian drugmakers tripled between 2010 and 2015, and that trend continues this year, with the latest to feel the…

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

Novartis is learning about its kickbacks punishment in South Korea as authorities decided to issue a fine of nearly $50 million.

What could China's newly proposed foreign drug policy mean for multinational pharma companies, and how will it change the world’s second-largest pharma…

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.

Regulatory