In a town hall meeting last Friday with employees, Ranbaxy Laboratories ceo and managing director Arun Sawhney held a town hall-style meeting to celebrate the widely anticipated launch of generic Lipitor. He starts with a call for ‘three cheers’ and, as can be expected, recounts the run-up to one of the most closely watched developments in the pharmaceutical industry this year.

The launch, however, was not a sure thing. The FDA approval did not occur until just as the 180-day exclusivity period was about to begin, thanks to long-running negotiations between the agency and the drugmaker over a series of manufacturing problems that threatened to prevent Ranbaxy from launching its generic.

Three years ago, federal prosecutors cited Ranbaxy for allegedly falsifying records resulting in the production and sale of meds that failed to meet FDA standards. The charges included fabricating bioequivalence and stability data. Later, the FDA issued warnings letters and banned more than 30 meds made at two plants (see this).

To prepare, Ranbaxy struck a deal with Teva Pharmaceuticals, which had already been selling a generic Lipitor in Canada, to help supply the pill. Sawhney calls this move an ‘insurance policy’ (You can watch the clip here). Ranbaxy, however, is also relying on its Ohm Laboratories facility in Princeton, New Jersey, but not its two plants in India that caused the manufacturing problems.

Not surprisingly, the video clip, which is obviously edited, makes no mention of the long-running and serious manufacturing issues that have haunted Ranbaxy during the past three years. Recognizing the drama, though, Sawhney unabashedly calls the episode ‘nothing short of a thriller.’ Of course, Ranbaxy shareholders would also be thrilled if Sawhney could finally fix those manufacturing problems.

Hat tip to BioPharma Today