In a rare bit of good news for Ranbaxy Laboratories, the generic drugmaker says its Ohm Laboratories facility in New Jersey successfully passed an FDA inspection. The move is significant because the plant is the only Ranbaxy manufacturing facility that is permitted to supply products to the US market after three plants in India were prevented from doing so thanks to serious quality-control issues.
The FDA endorsement means that Ranbaxy can use the Ohm facility to file for FDA approvals for drugs, such as a generic version of the widely used Diovan heart drug sold by Novartis (NVS). Ranbaxy had been expected to win agency approval a year ago to make a copy, but did not receive a green light due to problems at its Mohali plant, which was recently the subject of an FDA import ban (back story).
The establishment inspection report for the Ohm plant “should now pave the way for Ranbaxy for receiving fresh approvals from this facility, particularly the bigger first-to-file products, including the generic versions of Diovan and Valcyte,” an AIDS drug, Hitesh Mahida, an analyst at Fortune Equity Brokers, tells LiveMint.
Indeed, Ranbaxy had reportedly moved its application for a generic Diovan to Ohm Laboratories a few months ago and the FDA, at the time, was in the process of reviewing the application. The drugmaker took a similar strategy to gain approval for Lipitor generic, after its manufacturing sites at Paonta Sahib and Dewas were thwarted by an FDA ban (read this)
The move comes five months after Ranbaxy agreed to pay $500 million to the US Department of Justice to settle criminal and civil charges associated with a long-running manufacturing scandal that involved two its Paonta Sahib and Dewas plants in India, which continue to remain the subject of an FDA alert. The drugmaker is also working to get out from under a consent decree.
The US government had charged Ranbaxy with using raw chemicals from unapproved sources, fabricating in-house test data to meet FDA standards and concealing these activities from FDA inspectors by falsifying records. The episode seriously eroded confidence in its operations and, by extension, raised still more concerns about the safety of the pharmaceutical supply chain.
As noted previously, Mylan Laboratories (MYL) last year filed a lawsuit against the FDA, claiming Ranbaxy forfeited its right to six-month exclusivity to sell a generic version of Diovan by not winning regulatory approval. Late last year, though, a US district court ruled in favor of Ranbaxy, on the grounds that the delay in approval was caused due to a change in approval requirements (more here).
STORY ENDS HERE