Wockhardt slumps after FDA criticisms of new drug plant
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[January 15, 2016]
MUMBAI (Reuters) - Indian drugmaker
Wockhardt Ltd said the U.S. Food and Drug Administration (FDA) had
issued a notice outlining manufacturing violations at its Shendra plant
in western India, delaying the company's plans to rebuild its battered
In a so-called 'Form 483' issued to the company after a recent
inspection of the plant, the FDA listed nine concerns that Wockhardt
said it would respond to in "due course."
It did not disclose what the FDA's concerns were, and a company
spokesman did not respond to requests for comment through the day.
Wockhardt built the Shendra plant, which it claims is "a first of
its kind in Asia," to make difficult-to-manufacture injectable
products, and has been banking on it to reconstruct its business in
the world's largest healthcare market.
The United States once contributed a majority of Wockhardt's
revenue, but now makes up only about 19 percent, as the FDA banned
imports from two of its key drug plants over manufacturing quality
concerns over the last three years. Those plants are yet to be
cleared by the FDA.
Dozens of drug manufacturing plants in India have been banned or
cited for violations of standards by the FDA in the past three years
as the agency improved inspections of foreign drug plants. India
supplies about 40 percent of the generic and over-the-counter
medicines sold in the United States.
There are several steps between the issuing of a Form 483 and the
banning of a manufacturing plant.
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Wockhardt's stock slumped about 17 percent to its lowest in four
months on Friday, after the Indian television news channel ET Now
first reported the FDA notice. By the time Wockhardt issued a
statement, the stock had closed down 15 percent.
(Reporting by Zeba Siddiqui; Editing by Mark Potter)
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