Ranbaxy Consent Decree Includes Strict Requirements For Auditing Drug Applications
The agreement negotiated with FDA to resolve good manufacturing practice violations includes data integrity measures not commonly found in pharmaceutical GMP settlements, including auditing of almost all pending and approved drug applications and appointment of an independent data integrity expert.
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Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
Ranbaxy’s $500 Million GMP Settlement Would Be Second Most Expensive For Rx Manufacturing Violations
Ranbaxy Laboratories said it has signed a consent decree with FDA and set aside $500 million to settle a related Department of Justice investigation involving GMP violations and data integrity issues at its Indian facilities.
Ranbaxy launches generic atorvastatin despite not having reached a final settlement with FDA on GMP violations and data integrity issues. Teva’s role in Ranbaxy’s approval and launch is unclear, although the company will get a cut of the first-filer’s profits during the 180-day exclusivity period.