Ranbaxy Laboratories has started exports of a copycat version of blockbuster cholesterol drug Lipitor from a new facility in India that has been approved by the US 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 Dec.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 US 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 US 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 US-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.