Ranbaxy’s First-To-File ANDAs At Risk In FDA Data Integrity Probe
This article was originally published in PharmAsia News
Executive Summary
Several first-to-file ANDAs are on the line for Ranbaxy as it tries to resolve data integrity issues at its Paonta Sahib facility with U.S. FDA
You may also be interested in...
"We Know We Will Emerge Stronger In The U.S.," Says Ranbaxy CEO Atul Sobti: An Interview With PharmAsia News (Part 2 of 2)
Now under majority ownership by Daiichi Sankyo the Indian drug maker is revisiting its U.S. business model, with "very innovative" plans for generics, OTC and branded drugs, Sobti says.
"We Know We Will Emerge Stronger In The U.S.," Says Ranbaxy CEO Atul Sobti: An Interview With PharmAsia News (Part 2 of 2)
Now under majority ownership by Daiichi Sankyo the Indian drug maker is revisiting its U.S. business model, with "very innovative" plans for generics, OTC and branded drugs, Sobti says.
"We Know We Will Emerge Stronger In The U.S.," Says Ranbaxy CEO Atul Sobti: An Interview With PharmAsia News (Part 2 of 2)
Japan's third-largest drug maker, Daiichi Sankyo, acquired a 64- percent stake in India's most internationally known pharmaceutical brand - Ranbaxy - last June. The deal between an emerging innovator and an established generics drug maker surprised many, but was seen as a transformational one with a goal to expand reach and enhance cost efficiencies. Daiichi Sankyo was criticized later as concerns surfaced regarding Ranbaxy's manufacturing standards at two of its U.S.FDA-approved sites in India. After a complete management overhaul that saw Ranbaxy's promoter exiting the company, Daiichi Sankyo made Atul Sobti the CEO and managing director. In arguably the most in-depth interview after taking over the reins of Ranbaxy, Sobti, who has worked previously with companies like Hero Honda, opened up to PharmAsia News' India bureau on issues spanning U.S. FDA's actions to rebuilding Ranbaxy's reputation and opportunities in Europe, Africa, Japan and India.