Lupin gets FDA green signal for Mandideep facility; shares rise

Lupin shares were in demand on Wednesday after the drug maker received an establishment inspection report (EIR) from the US Food and Drug Administration (FDA) for its manufacturing facility in Mandideep, Madhya Pradesh. The Lupin stock gained by as much as Rs 11.8, or one per cent, to Rs 1,140.2 apiece in early deals on BSE, coming within Rs 75 of a 52-week high registered last month. 

In a regulatory filing post-market hours on Tuesday, Lupin said it had received the EIR from the US regulator for the Mandideep Unit-2 manufacturing facility.

The FDA inspected the Mumbai-based pharmaceutical company's facility from August 7 to August 11. 

The US regulator closed the inspection with a "no action indicated" status, which implies the absence of any objectionable item found during the inspection. 

“We are pleased to receive the EIR with a satisfactory inspection status from the US FDA for the recent inspection of our Mandideep Unit-2 facility. This accomplishment is in line with our continued focus and commitment to becoming best-in-class in quality and compliance, and enables us to continue delivering quality affordable healthcare solutions globally,” said Nilesh Gupta, Managing Director, Lupin.

Lupin is scheduled to report its financial results for the July-September period on November 8. 

Lupin shares: Past performance

As of October 31, the Lupin stock has rewarded investors with a return of 61.6 per cent in the past year, sharply outperforming a 4.9 per cent rise in the headline Nifty index. 

What does Lupin do?

Lupin, which has 15 manufacturing sites and seven research centers, develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in more than 100 markets in the US, India and South Africa, and across the Asia Pacific, Latin America, Europe and Middle East regions.

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