Lupin Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Tramadol hydrochloride extended release tablets in the US.
Tramadol ER is the generic version of Ortho-McNeil’s Ultrum ER tablets, indicated for the management of moderate to moderately severe chronic pain in adults who require 24/7 treatment of their pain for an extended period of time.
The company said that it will be “shipping its Tramadol ER shortly”.
Mumbai-based Lupin Limited is a global pharmaceutical company producing both generic and branded formulations and APIs. Its Lupin Pharmaceuticals headquarters is based in Baltimore, Maryland, USA.