FDA Inspected Wockhardt US Unit in March
May 27th, 2014 // 12:28 pm @ jmpickett
FDA has made some observations about the production process of the US unit of Indian generic drugmaker WockhardtLtd, 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% 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% drop in net profit for the March quarter, as it continues to reel under the US and U.K. import bans due to manufacturing quality lapses.
In November, the US 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.
