Ranbaxy Must Withdraw Several ANDAs Under DoJ Consent Decree; Will Lose 180-Day Exclusivity On Others
This article was originally published in The Pink Sheet Daily
Executive Summary
Three executives are named in the complaint, which the government calls “groundbreaking in its international reach.” The complaint cites GMP problems at four Ranbaxy facilities, three in India and one in New York, and says the company submitted false data in drug applications.