The stock of pharmaceutical company has under pressure, falling 28% in past seven trading sessions as compared to 1% rise in benchmark Sensex after the company has received warning letter from US Food and Drug Administration (USFDA) for its manufacturing facility in Maharashtra.
On July 20, the company said it has received a warning letter from USFDA, listing the observations made by it during its earlier inspection of the company's Waluj facility near Aurangabad, Maharashtra.
Wockhardt had on 24 May 2013 said that the company received an 'import alert' from USFDA on one of its manufacturing unit located at Waluj. The company at that time said that the impact of the import alert on the revenues is estimated to be in the range of $100 million on an annualised basis.
FDA said that until all corrections have been completed and FDA has confirmed corrections of the violations and the company's compliance with current good manufacturing practices (cGMPs), the agency may withhold approval of any new applications or supplements listing Wockhardt as a drug product manufacturer, the Bloomberg report suggest.
In addition, failure to correct the violations may result in FDA continuing to refuse admission of articles manufactured at the Wockhardt facility into the United States, added report.
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