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Ranbaxy Forecasts Conservative Growth, Remains Silent On Atorvastatin Launch, U.S. FDA Action

This article was originally published in PharmAsia News

Executive Summary

MUMBAI - Daiichi-Sankyo controlled Ranbaxy Laboratories Ltd. took analysts in India by surprise with a forecast of a very conservative growth target that did not factor in any upside from a possible launch of a generic version of Lipitor (atorvastatin) in the U.S

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Ranbaxy Sees "Progress" On Discussions With U.S. FDA, DOJ; Keeps Lipitor Launch Hopes Alive

MUMBAI - After staying non-committal for several months, Daiichi-Sankyo controlled Ranbaxy Laboratories Ltd. now says it has engaged in wide-ranging negotiations with U.S. FDA and the Department of Justice on multiple issues related to the alleged violation of good manufacturing practices at two of its India-based sites in Paonta Sahib and Dewas

Ranbaxy Sees "Progress" On Discussions With U.S. FDA, DOJ; Keeps Lipitor Launch Hopes Alive

MUMBAI - After staying non-committal for several months, Daiichi-Sankyo controlled Ranbaxy Laboratories Ltd. now says it has engaged in wide-ranging negotiations with U.S. FDA and the Department of Justice on multiple issues related to the alleged violation of good manufacturing practices at two of its India-based sites in Paonta Sahib and Dewas

Ranbaxy Talks Up Monetization Of First To Files Like Lipitor, Diovan, Actos if FDA Issues Stay Foggy; Are Big Launches Imperilled?

MUMBAI - With no clarity emerging whatsoever on how Ranbaxy Laboratories Ltd. will resolve its five-year long dispute with U.S. FDA - which has led to a blanket ban on drugs manufactured at one of Ranbaxy's largest India-based sites - analysts now speculate that the company will most likely "explore monetizing" its key first-to-file opportunities in the U.S. like Lipitor (atorvastatin), Diovan (valsartan), Nexium (esomeprazole) and Actos (pioglitazone)

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