Department of Justice seeks permanent injunction against Ranbaxy

The US Department of Justice, on behalf of the Food and Drug Administration, has filed a consent decree of permanent injunction against Indian generic drug manufacturer Ranbaxy in the US District Court of Maryland. The consent decree was filed against Ranbaxy Laboratories (RANB: BO), a 64% owned subsidiary of Japan’s Daiichi Sankyo, its subsidiary Ranbaxy Inc, and several of the group’s executives.

"This action against Ranbaxy is ground-breaking in its international reach -- it requires the company to make fundamental changes to its plants in both the United States and India," said Tony West, Assistant Attorney General for the Justice Department's Civil Division.
The consent decree will address outstanding current Good Manufacturing Practice (CGMP)
and data integrity issues at Ranbaxy's Paonta Sahib, Batamandi and Dewas facilities in India, as well as CGMP issues at Ranbaxy Inc's wholly owned subsidiary Ohm Laboratories facility located in Gloversville, New York. The four Indian facilities have been on FDA import alert since 2008 and Ranbaxy has closed its Gloversville facility. It does not, however, affect Ranbaxy’s marketing of a generic version of Pfizer’s Lipitor (atorvastatin), which the FDA approved after the blockbuster cholesterol lowerer lost its US patent protection (The Pharma Letter December 1, 2011).

It requires that Ranbaxy comply with detailed data integrity provisions before the FDA will resume reviewing drug applications containing data or other information from the Paonta Sahib, Batamandi, and Dewas facilities. Specifically, Ranbaxy must: