Ranbaxy's "corrective" plan under FDA review

Is there light at the end of the importing tunnel for Ranbaxy Laboratories? The FDA says it's reviewing the Indian drugmaker's "corrective action" plan, filed in response to last fall's ban [1] on 30 meds from two of the company's factories. The agency has also barred new generics from one of those two plants. The two bans cut deeply into Ranbaxy's revenues and sent its stock spiraling downward, at least until new CEO Abul Sobti said the company had submitted the plan, Bloomberg reports.

No word on just what the action plan includes. And the FDA hasn't said how long its negotiations with Ranbaxy might take. But the regulatory problems--and the underlying problems they exposed at the company--have taken a major toll, not only on the company itself, but on its new parent Daiichi Sankyo [2], which acquired a 64 percent stake last year. Daiichi put a firmer hand on Ranbaxy's tiller earlier this week, installing one of its own as chairman and replacing CEO Malvinder Singh with COO Sobti.

Meanwhile, Daiichi has revised its fiscal year results to restate the effect of Ranbaxy's slide on its own finances. New Japanese accounting guidelines allow the company to book a smaller loss on Ranbaxy stock, which changes Daiichi's net loss for the year ended in March to $2.26 billion from the $3.49 billion or so reported a couple weeks ago.

- read the Bloomberg story [3]
- check out the Wall Street Journal piece [4]

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Daiichi exerts control as Ranbaxy chief exits [5]
Burned on buyout, Daiichi to steer Ranbaxy ops [2]
Ranbaxy backs away from Europe [6]
FDA says Ranbaxy faked drug data [7]
FDA: Ranbaxy falsified data on drug applications [8]
To lift FDA ban, Ranbaxy may buy plants [1] [9]