Wockhardt Hopes To Resolve FDA Ban On Two Plants In FY16
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Generic drugmaker Wockhardt hopes to resolve all concerns raised by the US Food and Drug Administration (FDA) over manufacturing practices at two of its plants in the current financial year, its chairman said on Friday (29 May).
A resolution of the lapses would allow Wockhardt to resume exports from its two main India plants to the United States, a market that previously accounted for half of the drugmaker's global sales.
Wockhardt has been hit by slowing sales in the United States ever since the FDA banned exports from the company's Waluj and Chikalthana plants in Maharashtra in 2013, citing production quality lapses.
FDA inspected both plants earlier this year to check the actions taken by Wockhardt to address its concerns, Chairman Habil Khorakiwala told reporters, a day after the company reported more than halving of its quarterly net profit.
"We will continue to have a dialogue with them since they have seen all our facilities, and the issues are in front of them," he said. "We have given the whole program of corrective measures."
Wockhardt's sales in the United States dropped 21 per cent to Rs 290 crore ($45.5 million) in the quarter ended March, the company said in a statement on Thursday.
Pressure on the company's profitability and US sales will continue until the ban on its two plants are lifted, Khorakiwala said. Wockhardt is also seeking approval to export to the United States from its Shendra facility in Maharashtra.