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India's Sun Pharma says U.S. FDA to lift ban on Mohali plant exports

[March 14, 2017] MUMBAI (Reuters) - India's largest drugmaker Sun Pharmaceutical Industries said U.S. regulators plan to lift a ban on its Mohali plant in northern India, paving the way for a resumption of exports to the company's biggest market after four years.

The move would come as a boost to Sun, whose U.S. growth has been hit over the past year as five of its plants face supply restrictions due to regulatory issues. Sun's shares surged as much as 6.8 percent in Mumbai on Tuesday to a three-month high after the announcement.

Sun said on Tuesday the U.S. Food and Drug Administration (FDA) had informed it about the agency's plans to lift the ban on Mohali.

Analysts in Mumbai said the Mohali plant clearance may not add to sales immediately, but removes an overhang. Sun may now be able to shift production to Mohali from other plants such as Halol in western India, which face supply restrictions.

The Mohali facility came to Sun along with three other facilities through its acquisition of rival Ranbaxy Laboratories in 2015. The FDA had banned Mohali and other Ranbaxy plants in 2013 as part of a consent decree designed to ensure compliance with good manufacturing practices.

Sun said certain conditions would continue to apply even when the ban is lifted.

Regulators had found a series of violations including data manipulation at the plant, which Sun has been working on fixing over the past two years by hiring external consultants and automating procedures.

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Sun, the world's fifth-largest maker of generic drugs, reported its first fall in quarterly profits in a year last month, as pricing issues and supply constraints hurt U.S. sales.

Its shares gave up some of the day's earlier gains to be up 3.5 percent on Tuesday afternoon.

(Reporting by Zeba Siddiqui in Mumbai; Editing by Muralikumar Anantharaman)

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