Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.

Intas’ Accord overcame Purdue in Hatch-Waxman litigation involving the originator’s controversial opioid, Oxycontin extended-release.

Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.

The latest Generics Bulletin Top 50 ranking of global generics and biosimilars companies sees a new name in the top five amid transformations for some of the leading off-patent players. Meanwhile, a number of mid-level firms shift position and newcomers climb into the bottom of the table.