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Home » FDA Says Ranbaxy Applications Falsified, Halts ANDA Review
FDA Says Ranbaxy Applications Falsified, Halts ANDA Review
March 3, 2009
The FDA has suspended its review of new and pending drug applications that include data generated from Ranbaxy’s plant in Paonta Sahib, India, because of data integrity concerns, including the submission of falsified stability data in ANDAs, the agency says.