Daiichi riding GMP rollercoaster with FDA

For Daiichi Sankyo, the last few months have been a good news/bad news story with the FDA. The recent good news is that its subsidiary Ranbaxy, long entangled with the FDA over manufacturing violations, has begun preparing for a November launch of its generic version of Lipitor. The forward motion usually indicates the agency has come to some level of comfort that the company can and will get itself back on the GMP track.

Ranbaxy also announced this week it's talking with India's Ind-Swift, maker of APIs and finished goods, to source raw materials for the new generic.

Unfortunately for the company, there is some bad news. Luitpold Pharmaceuticals, another Daiichi unit, has received an FDA warning letter at its Shirley, NY, plant. Glass and silicone particle contamination in injectables have driven several recalls by the drugmaker, going back to late 2010.

The August letter to CEO Mary Jane Helenek that was recently made public by the FDA largely involves particle contamination issues, but it also includes other violations. The agency notes the lack of company investigations into particle contamination and product failures are repeat violations from inspections in 2010, 2009 and 2008. It also notes several instances during which the company's manufacturing procedures are insufficient, including one that "contradicts the need for an investigation if the number of vials rejected exceeds the reject limit," according to the letter.

"Notably, the rejection limit is exceeded," it says, in reference to that particular case.

- see the generic Lipitor sourcing story
- read this article
- here's the Morningstar report
- and peruse Warning Letter NYK-2011-33

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