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Indian generic drug-maker, Sun Pharma, has been notified by the US Food and Drug Administration that it can resume exporting drugs to US from its plant at Mohali, which it acquired as part of its 2015 purchase of troubled Ranbaxy.
In 2013, the US FDA issued an “import alert” warning that it would seize shipments of drugs made in the then four-year-old Mohali plant owned by Ranbaxy.
The import alert came just as Ranbaxy, then owned by Japan’s Daiichi-Sankyo, was set to start making generic versions of Novartis’ blood pressure drug, Diovan, and other drugs for export to the United States.
In a statement, Sun said it had been notified by the US regulator that the import alert would be lifted from the Mohali plant, which would also be removed from a list of facilities under investigation.
“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 US FDA regulatory requirements,” Sun said in a statement.
The US regulator’s action is an affirmation of Sun’s 2015 decision to purchase Ranbaxy, a troubled company that paid $500m in civil and criminal fines to the US authorities in 2013 to settle claims that it had sold adulterated medicines and provided false information to regulators.
In its statement, Sun said: “The development illustrates Sun Pharma’s commitment to work closely with the US FDA and strive for 100 percent compliance with good manufacturing practices at its manufacturing facilities.”