Drug maker Wockhardt on Wednesday said the US health regulator has not found any issues with respect to data security and control measures at Chikalthana plant in a recent inspection.
Drug maker Wockhardt Ltd on Wednesday said the US health regulator has not found any issues with respect to data security and control measures at Chikalthana plant in a recent inspection, but suggested continuous voluntary compliance for "desired quality culture".
"The recent inspection at the Aurangabad L1-Chikalthana site was a follow-up inspection by the US FDA as an outcome of completion of good manufacturing practise (GMP) remediation submitted by Wockhardt in October 2014.
"There were no findings with respect to data security and control measures in laboratory and manufacturing," Wockhardt said in a BSE filing.
The company further said: "The agency has indicated a common goal as voluntary compliance which shall be a continual process facilitating the concept of 'right the first time and every time' leading to desired quality culture."
In November 2013, US Food and Drug Administration had imposed restrictions on import of medicines produced at the company's Chikalthana plant at Aurangabad in Maharashtra due to non-compliance of good manufacturing practise.
Elaborating on inspection, Wockhardt said: "The observations on Form FDA 483 are on products manufactured prior to execution implementation of (GMP) remediation program."
"The efforts for data security control has been throughly verified during the inspection and have been appreciated as it is qualified and executed since September 2013," it added.
Wockhardt stock price
On March 18, 2015, Wockhardt closed at Rs 1878.35, down Rs 41.6, or 2.17 percent. The 52-week high of the share was Rs 1948.00 and the 52-week low was Rs 444.30.
The company's trailing 12-month (TTM) EPS was at Rs 33.45 per share as per the quarter ended December 2014. The stock's price-to-earnings (P/E) ratio was 56.15. The latest book value of the company is Rs 85.14 per share. At current value, the price-to-book value of the company is 22.06.
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