(Adds potential financial impact)
MUMBAI, May 23 (Reuters) - The U.S. Food and Drug
Administration imposed an "import alert" on a plant operated by
generic drugmaker India's Wockhardt Ltd, sending its
shares down 20 percent on Thursday to their lowest level in
An "import alert", effectively a ban, results in detention
without physical examination of drugs from firms that have not
met so-called good manufacturing practices, according to the FDA
Wockhardt said that the FDA's action potentially affects
$100 million in revenue on an annualised basis, but said it
should be able to restore most of that within 6 to 9 months by
shifting production to other facilities.
The company generated revenue of $908 million in the fiscal
year that ended in March 2012.
Wockhardt Chairman Habil Khorakiwala said the $100 million
figure was a "worst-case scenario," and said it was not clear
how long the ban would be in place.
"We have to interact with the FDA and deal with those
issues," he said on a conference call with reporters.
"We are making all kinds of effort to satisfy FDA with the
GMP (good manufacturing practices) compliance in that particular
facility," he said.
In April, Wockhardt said that the FDA had carried out an
inspection at its injectables plant in Aurangabad in western
India, and had issued form 483s to the company. A form 483 is
issued when inspectors see conditions that they believe may
violate U.S. rules, according to the FDA.
The company's shares fell 20 percent, their daily limit, to
close at 1,313.80 rupees in a Mumbai market that dropped
(Reporting by Tony Munroe and Sumeet Chatterjee, editing by