Addressing USFDA concerns over Waluj unit, says Wockhardt

The US health regulator has raised concerns over drug firm Wockhardt's Waluj plant and the company is taking steps to correct them within three to four months, according to its Chairman Habil Khorakiwala.
Stating that the US Food and Drug Administration conducted inspection for about a week, he said there were no serious observation and nothing on data integrity.
"However, there were some other observations. We are dealing with those observations and we would be able to respond and correct all of them in next three-four months," Khorakiwala said in a interview to television channel CNBC TV18.
On the company's plans to address the concerns raised by the USFDA, he said: "We would be able to respond and correct all of them in next three-four months...We believe that all observations were something our team will be able to correct it, many of them actually in next month or so and the balance three to four months."

The company's Waluj plant was earlier hit by an import alert by the USFDA in 2013 for not meeting manufacturing norms. The plant produces injectables as well as solid dosages.
Khorakiwala said almost all the previous issues had been addressed by the company.

"I think as far as the earlier observations were concerned, almost all of them were complied with. There were minor procedure areas, one or two, which is being corrected by changing of the written down procedures," he added.
On the company's Chikalthana facility, Khorakiwala said: "We have invited them (USFDA) to come and visit us and we are also ready with it."

The company's Chikalthana facility was also put under import alert by the USFDA on the issue of non-compliance of manufacturing norms.
Shares of Wockhardt ended the day at Rs 1,549.75 per scrip, down 3.45 per cent from the previous close on the BSE.