India's
Wockhardt says FDA raises new concerns about Waluj plant
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[February 26, 2015] By
Abhishek Vishnoi and Zeba Siddiqui
MUMBAI (Reuters) - Shares in Wockhardt Ltd
fell as much as 5.3 percent on Thursday after the Indian drugmaker said
the U.S. Food and Drug Administration had raised fresh concerns about a
plant already banned from exporting to the United States over quality
issues.
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CEO Habil Khorakiwala, in an interview with channel CNBC TV18, did
not specify the FDA concerns, which he said were raised after a
week-long inspection of Wockhardt's Waluj manufacturing plant in
central India. But he said the issues were not serious and would
likely be resolved within months.
Wockhardt's shares closed 3.4 percent lower, while the wider NSE
market fell 0.95 percent.
"There were no serious observations," Khorakiwala said. "We are
dealing with those observations and we would be able to respond and
correct all of them in next three-four months."
A transcript of the interview was published on the TV channel's
website.
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Waluj is one of seven plants in India owned by Wockhardt, which also
has production facilities in the United States, Britain and Ireland.
Like other Indian generic drugmakers, the United States is the
largest market for Wockhardt, accounting for 43 percent of its
revenue in the quarter ended in September 2013.
The FDA has banned imports from the Waluj plant since May 2013 over
concerns related to manufacturing practices. It has also imposed a
similar ban on another Wockhardt plant in Chikalthana, western
India.
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The FDA does not publicly disclose the results of its inspections or
give details about its observations.
The FDA has in recent months raised concerns about manufacturing
practices at the India-based plans of several firms including Lupin
Ltd and Sun Pharmaceutical Industries Ltd.
(Editing by Rafael Nam and Miral Fahmy)
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