MUMBAI (Reuters) - Ranbaxy Laboratories Ltd has started exports of a copycat version of blockbuster cholesterol drug Lipitor from a new facility in India that has been approved by the U.S. Food and Drug Administration.
The company, majority owned by Japan’s Daiichi Sankyo, has been selling the generic version in the United States since last December 1 from its facility in America but exports to the United States from its plants in India were banned in 2009 over disputes related to compliance issues.
Ranbaxy, India’s biggest drugmaker by sales, said on Monday the U.S. authorities approved the generic dosages manufactured at the Punjab facility in northern India in the first quarter of this year.
“Our new facility will cater to the U.S. and other geographies, improving access to medicines, in these regions,” Chief Executive Arun Sawhney said in a statement.
Ranbaxy started selling the generic version of Lipitor in four European markets - Germany, Italy, the Netherlands and Sweden - from its U.S.-based Ohm Laboratories Inc early this year.
Analysts said Ranbaxy would have to boost sales for the operation to become cost effective.
“We need to check on the volumes that are shipped from India,” a pharmaceuticals analyst in Mumbai said. “The benefits won’t be too high unless exports to the European markets rise substantially from India.”
Lipitor, sold by Prizer, became available in 1997 and generated worldwide annual sales of $13 billion at its peak. It lowers “bad” LDL cholesterol and the risk of heart attack and stroke.
It chalked up more than $130 billion in sales for Pfizer until its patent ended last November and many analysts doubt if another drug of its magnitude will be seen again, in part because drugmakers are moving to a model of more personalized medicine.
Valued $3.85 billion by the market, shares in Ranbaxy were down 2.3 percent at 458.70 rupees at 0738 GMT in a firm Mumbai market. The stock, however, has gained more than 12 percent in the year to date.
Reporting by Kaustubh Kulkarni; Editing by Ranjit Gangadharan