Wockhardt aims to convince investors FDA woes on path to getting fixed

Wockhardt chairman Habil Khorakiwala

It's not exactly a charm offensive, but India's Wockhardt is going out of its way to tell investors and, hopefully, the U.S. FDA, that manufacturing quality woes are on the way to being fixed.

Chairman Habil Khorakiwala said at a press conference last week that the conversations needed to get back on track are ongoing as disclosed quarterly net profit fell by half in the quarter ended March 31 as a ban on exports to the U.S. from two India plants remained in force.

Last month the company also recalled a dozen of its drugs remaining on the U.S. market because they were produced at either of two sites.

"We will continue to have a dialogue with them (the U.S. FDA) since they have seen all our facilities, and the issues are in front of them," he said at a press conference, according to Reuters. "We have given the whole program of corrective measures."

A recent story in India's Business Today highlighted the steps taken by the company to repair damage from a FDA ban on the plants in Waluj and Chikalthana in 2013.

The FDA said, among other problems, that employees there had been manipulating data to indicate that batches that had failed testing had instead met specifications. Those products were then sold in the U.S.

Analysts cited in the story said that the recall in particular changed the math for earnings and sales estimates again for the beleaguered firm, despite Khorakiwala saying it was not "significant."

"We had assumed a $100 million impact on the top line and 5% impact on EBITDA margins for 2013/14 following U.S. FDA issues regarding the Waluj plant," Emkay Global analysts Deepak Malik and Krishnanath Munde told Business Today of estimates well before the recall.

In March, the company issued a market filing that the FDA in a follow-up visit to the Chikalthana plant was impressed with its efforts "to bring about a culture change and to build a robust quality management."

In that disclosure, Wockhardt said its efforts to secure its computer systems had been "verified" by the agency.

- here's the story from Reuters
- and the Wockhardt earnings results
- get more from Business Today