Ranbaxy Compliance Issues Mount, FDA Halts Application Reviews

The FDA is accusing Ranbaxy of submitting falsified stability data in ANDAs that include information generated from the company’s plant in Paonta Sahib, India, and new and pending applications referencing information from the facility will not be reviewed by the agency until the suspect data are validated. The agency is invoking its application integrity policy for Ranbaxy drug applications with data from the plant, the FDA said.
Drug Industry Daily