Certain consent decree terms to apply to Mohali unit: Ranbaxy
New Delhi: Ranbaxy Laboratories on Tuesday said apart from the import alert on it's Mohali facility the US health regulator has also said that the unit will 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, USFDA said.
The USFDA had conducted inspections at the company's Mohali facility in 2012 resulting in certain observations, Ranbaxy said in a separate statement.
"Ranbaxy will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest," the company said.
This is the third Ranbaxy plant, after units at Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh), that has received the US import alert.
The Mohali plant produces oral solids in dosage form, according to the company's website. The US is Ranbaxy's largest market, with sales of Rs 770 crore in the quarter ended June 30.
According to information on the US Food and Drug Administration website, the import alert on Ranbaxy's Mohali plant dated September 13 covers all 'drugs and drug products' produced by the company at the facility.
While the FDA did not specify details, it said:"Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practises."
Shares of Ranbaxy Laboratories today closed at Rs 330 per scrip on BSE, up 3.50 percent from previous close.