Wockhardt looks to get banned plants back online in 2016

Wockhardt Chairman Habil Khorakiwala

Indian drugmaker Wockhardt says remediation work at two plants that the FDA banned in 2013 will drag into 2016. The remarks by Chairman Habil Khorakiwala came a day after the Indian drugmaker reported that sales in the U.S. last fiscal year were off by 50%.

The company is talking with U.S. regulators about allowing products from its plant in Shendra to be sold in the U.S., The Economic Times reports, but Khorakiwala told reporters that profits will be squeezed until the bans on the plants in Waluj and Chikalthana are resolved.

The U.S. was the company's most profitable market and accounted for nearly half of its revenues before the bans. That was down to 35% in fiscal 2014 and had dropped to 27% in the most recent year ended March 31, the company reported over the weekend. The company said sales in the U.S. last year were about 1,087 crore ($170 million.) They were about $45.5 million for the quarter, off 21%.

"We will continue to have a dialog with them since they have seen all our facilities, and the issues are in front of them," Khorakiwala said. "We have given the whole program of corrective measures."

The company in April disclosed that following the FDA re-inspection earlier this year it had begun to recall all products still in the U.S. that had been manufactured at Waluj and Chikalthana before the bans were instigated two years ago.

The FDA had banned the plants after inspectors found that employees there had been manipulating data to indicate that batches that had failed testing had instead met specifications, then selling those in the U.S. Inspectors also found that employees were then deleting from some computers indications that batches had not met specifications, also a big problem in the FDA's view.

Wockhardt still has 69 ANDAs pending before the FDA for the U.S., 14 of which it filed last year.

- here's the earnings report (PDF)
- and the Economic Times story