Lupin drops on FDA observations; company reassures of no disruption at facility

pharmafile | March 29, 2016 | News story | Business Services, Manufacturing and Production, Sales and Marketing Lupin, US FDA, regulation 

Shares of India’s Lupin dropped over 14% Tuesday following news the US Food and Drug Administration (FDA) has made observations over one of its key manufacturing plants.

However, investors pared some pf the losses as the company reassured the observations for its Mandideep facility were minor in nature. Lupin said it doesn’t expect any supply disruption at the facility.

The stock closed down 6.3 percent to 1,401.45 rupees, on the Bombay Stock Exchange.

Lupin said there were a total of three observations made by the US FDA following the inspection of its Mandideep manufacturing facility in Madhya Pradesh between 2 February and 19 February 2016. 

“We believe that these observations are minor in nature and have already addressed these,” the company said in a statement, adding, “We believe the outcome of the audit will be voluntary action indicated only and there will be no remediation required.”

Anjali Shukla                                         

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