Ranbaxy Laboratories ($RANBAXY.NS), which has been having extensive manufacturing problems that led to a groundbreaking settlement last month with U.S. authorities, has a new FDA-approved plant in India from which it is shipping a generic Lipitor to the U.S.
The Indian generics-maker said the FDA signed off on the Mohali facility in October and extended its OK in the first quarter of 2012 to 10mg, 20mg, 40mg and 80mg dosages of Atorvastatin tablets. The company lost no time getting the drugs to market and delivered its first shipment to the U.S. in March. The company says this supplements current production from Ohm Laboratories in the U.S.
Without mentioning the settlement, Ranbaxy CEO Arun Sawhney made note of the significance reached by again shipping drugs from one of India's plants in a statement. "The resumption of supplies from India into the U.S. market is a significant milestone for Ranbaxy. Going forward, our Mohali facility will cater to the U.S. and other geographies, improving access to medicines in these regions."
Problems at Ranbaxy plants came to light in 2009 and led to bans of drugs from certain facilities, including some in India. The problems were extensive; one issue was a lack of procedures to prevent contamination of sterile drugs. Probably the most serious finding was that the company falsified data submitted to the FDA.
In January, Ranbaxy, which is owned by Daiichi Sankyo in Japan, signed a consent decree with the Department of Justice with input from the FDA. As part of the deal, Ranbaxy has to set up safeguards to make sure fake data doesn't make its way into company filings again. The company has to pay an auditor to watch over its shoulder and report to the FDA on whether Ranbaxy is meeting all of the stipulations. And to make sure that the company got the point, it had to forfeit its 180-day exclusivity on three drugs and face the same threat on three others.
Ranbaxy says that in addition to the FDA, the new plant has been signed off on by other world regulatory groups like Canada Health, the TGA in Australia and the World Health Organization.
Early this year, the company began shipping generic Lipitor from its U.S. operations to Germany, Italy, Sweden and the Netherlands, Reuters points out. With supplies from the new plant also headed to Europe, analysts say it will have to markedly increase sales there to generate the volumes necessary to make the new plant efficient.
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