UPDATE 1-Ranbaxy's US launch of lipitor generic on track - Nikkei
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Sept 8 (Reuters) - Ranbaxy Laboratories Ltd will release a generic version of the blockbuster cholesterol-lowering drug Lipitor in the United States at the end of November as planned, the Nikkei reported, citing a top official.
Ranbaxy's scheduled launch of the drug has been clouded by speculation that regulatory troubles could derail its plans.
There is "no change" to the timetable, said Tsutomu Une, the chairman of the board of the Indian generic-drug maker, in an interview with the Nikkei daily in New Delhi.
Une also dismissed speculation that Ranbaxy would sell its marketing rights to another firm.
The company will have exclusive U.S. sales rights to a generic version of the blockbuster Pfizer Inc drug for 180 days. In May, a U.S. judge dismissed an attempt by Mylan Inc to speed up getting its generic version of Lipitor on the market and block an exclusive for a generic by Ranbaxy.
Bans keeping Ranbaxy from exporting some products to the United States remain and it is widely believed that the company will not be able to sell Lipitor's generic there unless such restrictions are lifted, the daily reported.
In 2008, the U.S. Food and Drug Administration said there were quality control problems at two of the firm's Indian factories, and in 2009 Ranbaxy was accused of fabricating data in drug applications at one facility.
On reports that the FDA may fine Ranbaxy more than $1 billion, or roughly 80 billion yen, Une said the actual figure would likely be lower based on past cases, the Nikkei reported.
Fines of $1 billion "would hurt Ranbaxy severely, and the impact on Daiichi Sankyo will be large as well," he said. (Reporting by Shravya Jain in Bangalore; Editing by Saumyadeb Chakrabarty)
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