Ranbaxy, Another Bad FDA Report & The Missing Generic Diovan

Once again, Ranbaxy Laboratories may be facing a showdown with the FDA. The troubled generic drugmaker, which only recently agreed to pay $500 million to the US Department of Justice to settle criminal and civil charges associated with a long-running manufacturing scandal (see this), recently received a poor inspection report from the FDA for one of its facilities in India. The 483 report, which typically details various violations of good manufacturing practices, was issued earlier this year for a plant in Mohali, according to The Business Standard. And the report is significant in two different ways. For one, the report follows a commitment by Ranbaxy to fix its manufacturing ills and avoid further regulatory trouble. Ranbaxy did not comment specifically on the 483 to the paper, and an FDA spokesman declined to comment to us. Moreover, the paper notes added FDA scrutiny comes just as the Mohali plant had assumed additional strategic importance after two other plants in India were the focus of the far-reaching manufacturing scandal. That imbroglio involved using raw chemicals from unapproved sources, fabricating in-house test data to meet FDA standards and attempting to conceal the ruse from FDA inspectors by falsifying records. In fact, the Mohali plant was cited by FDA inspectors as part of the process for approving a Ranbaxy application to market valsartan, the generic version of Diovan, a widely used heart drug sold by Novartis. Ranbaxy, which won 180-day exclusivity, h...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs