MUMBAI May 27 The U.S. Food and Drug
Administration (FDA) has made some observations about the
production process of the U.S. unit of Indian generic drugmaker
Wockhardt Ltd, the company said on Tuesday.
The FDA last year banned Wockhardt's two Indian units from
exporting to the United States, its biggest market, citing
quality lapses in the manufacturing process.
Managing Director Murtaza Khorakiwala told an analysts
briefing the FDA had inspected the company's Chicago-based
Morton Grove Pharmaceuticals unit, which accounts for more than
50 percent of its sales in the United States, in the March
quarter. He did not give further details.
"It's difficult to say what kind of position the FDA will
take but according to us the inspection was not a very negative
inspection," Khorakiwala said.
Wockhardt on Monday reported a 78 percent drop in net profit
for the March quarter, as it continues to reel under the U.S.
and U.K. import bans due to manufacturing quality lapses.
In November, the U.S. Food and Drug Administration (FDA)
issued an import alert, effectively a ban, against Wockhardt's
Chikalthana plant in western India. The FDA had imposed a ban on
the company's Waluj plant in May.
(Reporting by Zeba Siddiqui; Editing by Miral Fahmy)