Main > A1. CORP. INDEX. R-Rm > Ranbaxy/P > 2008. 07.21.2008. USA>DOJ>Probe

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In its July 3 filing at the U.S. District Court for the District of Maryland, DOJ alleges that Ranbaxy submitted "false and fabricated" information to FDA about stability and bioequivalence and attempted to conceal violations of current Good Manufacturing Practices.

According to the filing, "evidence suggests that Ranbaxy uses [active pharmaceutical ingredients] from unapproved sources, blends unapproved API with approved API, and uses less API in its drug than had been approved by the FDA" and that these conditions may lead to a drug that is "subpotent, superpotent, or adulterated."




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