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Wockhardt gets warning from USFDA over Chikalthana plant at Aurangabad

27 November, 2013

In another setback to Mumbai-based generic drugmaker Wockhardt Ltd, it has received an import alert from US Food and Drug Administration (FDA) for its Chikalthana plant at Aurangabad in Maharashtra. 

This the second import alert issued by US FDA to the company, after issuing one for the Waluj facility near Aurangabad early this year. 

“USFDA has posted on its website an import alert on the manufacturing unit at L1, Chikalthana, Aurangabad,” the company said in a stock exchange announcement. 

According to stock exchange announcement issued on Wednesday, there is a ban on the products manufactured from these units, including Metoprolol XR which is used for treating blood pressure. The company also added that five products have been excluded from import alert. 

“The company has already initiated several steps to address the observations made by the USFDA and shall put all efforts to resolve the matter at the earliest,” the company said. 

This comes as a blow to the company, which had its Good Manufacturing Practice (GMP) certification revoked by UK’s drug regulator a few months ago. Recently, its Daman facility also saw its GMP certification revoked. 

Habil Khorakiwala, chairman of Wockhardt had earlier this year said that the company could lose up to $100 million in annualised revenue due to US FDA import alert for its Waluj plant. 

The scrip of Wockhardt was trading at Rs 430.15, down 8.87 per cent from previous close of Rs 472.

(Edited by Joby Puthuparampil Johnson)


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Wockhardt gets warning from USFDA over Chikalthana plant at Aurangabad

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