Despite manufacturing mishaps that ultimately blocked some 30 Ranbaxy drugs from U.S. sales for the last year and a half, Japanese parent Daiichi Sankyo maintains great expectations of the generics-maker. Daiichi president Takashi Shoda says not only that he expects the FDA import ban to be lifted by 2012, but that the Indian subsidiary will serve up 23 percent of the aggressive Japanese pharma's earnings that same year, rising from 15 percent today--that's 270 billion yen, rising from 148 billion yen.
The regulatory waters started getting hot for Ranbaxy in 2008 on its home turf: manufacturing defects at its Paonta Sahib and Dewas facilities in India were compounded by falsified data, eventually led to the import ban. More recently, Ranbaxy's U.S.-based unit, Ohm Laboratories in Gloversville, NY, went several rounds with the FDA, which ultimately described the drugmaker's corrective actions "inadequate," as we've reported.
The company showed some seriousness at getting its act together when it pulled in high-end consultancy PRTM to get things moving at Ohm, and when Daiichi Sankyo sent a QC exec to Ranbaxy.
The FDA is "troubled" by Ranbaxy's manufacturing and data integrity issues, according to a New York Times article, and promises to focus on the company until "fully satisfied" with the quality of its drugs and the integrity of its data." Daiichi Sankyo and Ranbaxy executives have put together a joint task force to make sure quality-control systems are in place and will improve, she said.
- here's a press report
- see the NYT article