Ranbaxy, FDA enter consent decree over GMP, data breaches

Plans for the $500 million that Daiichi Sankyo set aside to get problem child Ranbaxy out of regulatory jail became clearer Wednesday with the filing of a consent decree. The Indian-based drugmaker and the FDA have agreed to terms that will allow the manufacturer to end several years of market restrictions imposed by the regulator for manufacturing and data-reporting violations.

The court action stems from issues stretching back to 2008. Prominent among them was the company's inadequate separation of penicillin and non-penicillin drug production and inadequate attempts to prevent the contamination of sterile drugs, according to Bloomberg. Alleged falsification of data in manufacturing and other records was another driver, said IBN.

The consent decree was described as "unprecedented" in its international scope, said the Justice Department in the IBN report. The agreement was signed in December and filed Wednesday in a Maryland court.

The decree's terms prevent Ranbaxy from manufacturing drugs for the U.S. market at facilities in Paonta Sahib, Batamandi and Dewas, India, until drugs can be manufactured at such facilities in compliance with U.S. manufacturing quality standards. The facilities were previously tagged for GMP violations that led to an FDA import alert.

As reported last month, Daiichi earmarked $500 million to resolve Ranbaxy liabilities, causing the Japanese giant to cut pay for executives and directors.

- here's the FDA release
- see the Bloomberg report
- here's more from IBN Live


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