Ranbaxy Laboratories, on Tuesday, said apart from the import alert on its Mohali facility, the U.S. health regulator had said that the unit would be subject to certain terms of the consent decree signed in January, 2012.
“The FDA also ordered that the Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January, 2012,” according to United States Food and Drug Administration website.
The decree contains provisions to ensure CGMP (current good manufacturing practices) compliance at certain Ranbaxy facilities, including in Paonta Sahib and Dewas, India, as well as provisions addressing data integrity issues at those two facilities, the USFDA said. The USFDA had conducted inspections at the company’s Mohali facility in 2012, resulting in certain observations. Ranbaxy shares on Tuesday closed at Rs.330 on the BSE, up 3.50 %.
