Wockhardt Falls Most in Four Months After FDA Warns U.S. Unit

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Wockhardt Ltd. fell the most in almost four months after its U.S. subsidiary received a warning letter from regulators, preventing new product approvals from the unit’s factories and adding to an already long list of sanctions against the company.

The Mumbai-based firm has initiated measures to address the issues raised by the U.S. Food and Drug Administration and the current portfolio of products already approved from its Morton Grove Pharmaceuticals facilities will continue to be available in the U.S., it said in a statement. Share fell as much as 6.5 percent after the market opened in Mumbai to 701 rupees per share, the biggest decline in almost four months on an intra-day basis. It traded 4.4 percent lower at 9:37 a.m. in Mumbai.

The action against Wockhardt’s U.S. unit follows an FDA warning letter against its U.K. subsidiary just three months ago. Three of its Indian plants have been banned from exporting to the U.S. by the FDA for manufacturing violations.

Revenue from Wockhardt’s U.S. business declined by 29 percent in the third quarter, leaving it at 20 percent of global revenues, according to a company release. It had 81 applications for new generic drugs awaiting U.S. approval.