Nifty Pharma gains 2% as sentiment boosted after Dr Reddy#39;s Duvvada unit gets EIR from USFDA

November 21
19:05 2017
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Pharma stocks hogged the limelight on Tuesday as Nifty Pharma index rallied 2.2 percent after drug firm Dr Reddy’s Labs received establishment inspection report from the US FDA for Duvvada facility.

The stock was biggest gainer among Nifty 50 stocks, rising 5 percent; followed by Sun Pharma (up 4 percent), Lupin (1.4 percent), Cipla (2 percent) and Wockhardt (3.51 percent).

DRL informed exchanges that it has received the establishment inspection report from the US FDA for its formulation manufacturing facility at Duvvada in Visakhapatnam but the health regulator has not closed the inspection.

The company is planning to request a re-inspection in 2018 after further discussion on scheduling with FDA.

The rally was largely on hope of early clearance to several facilities of pharma majors that received import alerts and warning letters from the US Food and Drug Administration.

Healthcare major Sun Pharma’s Halol plant will be reinspected by USFDA soon. The plant had received warning letter in December 2015.

Dr Reddy’s Labs’ Srikakulam API had received warning letter in November 2015 and Bachupally plant received observations in 2017.

Wockhardt’s Waluj and Chikalthana plants have been under import alert since 2013 and Ipca Labs’s Ratlam, Pithampur and Piparia plants since 2015.

On November 6, Lupin received a warning letter issued by the USFDA for formulation manufacturing facilities at Goa and Indore (Pithampur unit II).

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