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The QMN Weekly Bulletin
Aug. 31, 2012 | Vol. 4 No. 35
Ranbaxy Withdraws 27 Approved ANDAs Under Consent Decree
Ranbaxy has withdrawn its approved ANDAs for 27 U.S. drugs to focus on other applications and fixing good manufacturing practice deviations that prompted a consent decree earlier this year.
The consent decree specifies that Ranbaxy must never submit another application to the FDA for the withdrawn drug products and must never transfer the ANDAs to a third party. The products are no longer marketed, so the move will have a negligible impact on the company, it said.
Ranbaxy entered into the consent decree in January to resolve lingering manufacturing problems at two Indian plants. The decree commits the company to “corrective steps” to address issues cited in two Sept. 16, 2008, warning letters and an import alert for 30 generic drugs.
During inspections, the FDA found several GMP violations, including failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating drugs did not meet specification; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs to prevent cross-contamination and inadequate aseptic procedures.
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