Dr Reddy’s Laboratories (DRl) had settled its claims against Nordion (formerly MDS), headquartered in Ottawa, Canada, in a case pending in the United States District Court for the District of New Jersey, for a cash payment of $22.5 million by Nordion to DRL. The settlement was concluded on March 20, 2013, with the receipt of the settlement funds by DRL.
The case was brought by DRL in April 2009 seeking damages sustained by the company caused by a claimed breach by Nordion of its Laboratory Services Agreement with DRL. Nordion, as a contract research organisation, provided laboratory services to DRL, including bio-equivalency studies, to support DRL regulatory applications for approval of generic drugs, including Abbreviated New Drug Applications (ANDAs) filed with the United States Food and Drug Administration (USFDA) for approval to market generic drugs in the US.
The case arose after the US FDA cited MDS with violations of good laboratory practices which caused the US FDA not to accept, without further substantiation, MDS’s laboratory reports performed during the period 2000-2004.
EP News Bureau – Mumbai