Wockhardt shares hit fresh 52-week high at Rs 1,980

Says USFDA has not found any issues with its Chikalthana plant

The Wockhardt stock soared to a 52-week high of Rs 1,980 on Thursday, following a clarification that the US Food and Drug Administration (US FDA) didn’t find anything untoward during an inspection of the company’s Chikalthana plant in Maharashtra.

The stock closed at Rs 1,909.8 on the BSE, up 1.67 per cent compared to the previous close.

“The recent inspection at the Aurangabad L1-Chikalthana site was a follow-up inspection by the US FDA, as an outcome of the completion of the good manufacturing practice remediation filed by Wockhardt in October. There were no findings with respect to data security and control measures in laboratory and manufacturing,” the company said in a filing.

Since February 27, the stock has surged 20 per cent. This followed the company announcing there were no serious observations raised by the US FDA on its manufacturing facility in Waluj, Aurangabad.

“The efforts for data security control have been verified during the inspection and appreciated. These have been executed since September 2013,” the company said.

But analysts said, of seven US FDA observations on the Waluj facility, some were serious. A recent report by IndiaNivesh Securities said, “One observation is a repeat of a 2013 US FDA inspection, which indicates less measures by the management to address the issue. The observation highlights laboratory records not having complete data of all tests and examinations, necessary to comply with established standards.”

In November 2013, the FDA had issued an alert against the Chikalthana plant due to non-compliance with good manufacturing practice. In May that year, the regulator had imposed a ban on the company’s Waluj plant, after inspectors found torn data records in a waste heap, as well as urinals that emptied into an open drain in a bathroom, six metres from the entrance to a sterile manufacturing area.

Following the import alerts, Wockhardt’s US business had declined 56.3 per cent in the second quarter of FY15, contributing only 24 per cent to the company’s global revenues.