Ban on FDA-regulated drugs from Ranbaxy's Mohali plant

There was another blow for India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359) yesterday (September 16), when the US Food and Drug Administration issued an import alert under which US officials may detain drug products manufactured at Ranbaxy facility in Mohali, India.

Ranbaxy, which is majority owned by Japan’s Daiichi Sankyo (TYO: 4568), will remain on the import alert until the company complies with US current Good Manufacturing Practices (cGMP). The Indian firm’s shares plunged more than 30% on the news.

The FDA also ordered that the Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy last year (The Pharma Letter January 27, 2012). The decree contains provisions to ensure cGMP compliance at certain Ranbaxy facilities, including in Paonta Sahib and Dewas, India, as well as provisions addressing data integrity issues at those two facilities. Ranbaxy’s Paonta Sahib and Dewas facilities have been on FDA import alert since 2008.