NEW DELHI: The US health regulator has proposed to lift the import alert on Sun Pharma's Mohali-based plant, paving the way for the drug major to resume exports to the American market after a gap of nearly four years.
The company has been informed by the US Food and Drug Administration (USFDA) that it will lift the import alert imposed on the Mohali plant and remove the facility from the Official Action Initiated (OAI) status, Sun Pharmaceutical Industries said in a statement. "This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal USFDA regulatory requirements," it added.
Following the announcement, shares of Sun Pharma rose by 3.61 per cent to Rs 708.25 at close on BSE.
The Mumbai-based drug major had inherited the Mohali facility as part of its acquisition of Ranbaxy Laboratories in an all-stock transaction worth USD 4 billion in April 2015. The USFDA had taken action against the Mohali facility in 2013 when it ordered the plant to be fully subject to Ranbaxy's Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility, Sun Pharma said.
"This development illustrates Sun Pharma's commitment to work closely with the USFDA and strive for 100 per cent current good manufacturing practices (cGMP) compliance at its manufacturing facilities," the statement said.
In September 2013, the USFDA had issued an import alert on drugs produced at then Ranbaxy's Mohali plant for violation of current good manufacturing practices. Ranbaxy in May 2013 had pleaded guilty to "felony charges" relating to manufacture and distribution of certain 'adulterated' drugs made at two units in India and had agreed to pay USD 500 million to US authorities as penalty. This followed a series of action taken by the USFDA, which in 2008 banned import of 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh) plants for violation of manufacturing norms.
All the four manufacturing facilities of erstwhile Ranbaxy — Mohali and Toansa in Punjab, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh — have been banned by the USFDA from exporting drugs to the US market.