India's Sun Pharmaceutical Industries has decided that a triage strategy is needed to address the poor state of four Ranbaxy Laboratories manufacturing plants banned by the U.S. FDA in the past 5 years. And that may mean one unit may not make it, the Economic Times reports.
The plan now is to get the plants in Mohali, Dewas and Toansa back online in an orderly fashion, placing a priority on Mohali, and leaving the plant in Poanta Sahib to take down its former lead role to the U.S. market and keep producing for other markets, including the World Health Organization as well as Europe and Australia, the Economic Times said.
That would be a big come down for the Poanta Sahib plant, the Economic Times said, citing industry veterans who note it was used by Ranbaxy in regulatory filings in the U.S. for the generic versions of blockbuster drugs like Lipitor.
The plant closest to coming back online is Mohali, which had an import alert imposed in September 2013 and was part of a separate consent decree process with the U.S. FDA that brought a $500 million fine against Ranbaxy. However, sources told the Economic Times that corrections in manufacturing practices as desired by the U.S regulator are complete a report will soon be handed in a few months to get it restarted.
Uday Baldota, Sun Pharma's chief financial officer, in an emailed statement to the Economic Times, indirectly hinted that may be the right order of care.
"We have four facilities under consent decree (agreement to settle a dispute without admission or denial of guilt) and have decided to focus on bringing one of these facilities back into compliance. Once that facility comes back into compliance, we will devote similar resources to bring other facilities back into compliance too," he told the newspaper.
|Sun Pharma managing director Dilip Shanghvi|
On a July 20 call with investors Sun Managing Director Dilip Shanghvi also indicated that the company expected to resolve at least one of Ranbaxy's banned facilities soon, without naming the site.
After the market close on Monday, July 20, Shanghvi provided sobering details on the financial impact of the efforts to reorganize the firm as India's top drug company and the fifth largest generic producer in the world moves ahead from the heady all-stock deal selling Ranbaxy Laboratories to Sun in March of this year.
In addition to the Ranbaxy unit, a plant owned by Sun at Halol also has to clear U.S. FDA regulatory hurdles.
- here's the story from the Economic Times