MUMBAI, May 27 (Reuters) - 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)