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 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.

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.

The FDA posted a document outlining the issues that have undermined AstraZeneca's efforts to win approval for ZS-9.

The FDA’s decision to ban the products of a Chinese API maker has left the World Health Organization in the lurch trying to find another company to supply the…

India’s Indico Remedies has had a sterile injectables plant blasted in an FDA warning letter for its laissez-faire approach to dealing with consumer complaints.

Drug Safety