Capitalstars Updates: USFDA clearance for Dr. Reddy’s Duvvada unit likely to get delayed: 3 Jan 2018

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Shares of Dr. Reddy’s Laboratories fell nearly 2.5% on fears that clearance for the company’s injectables unit in Duvvada, Andhra Pradesh, may get delayed by the US Food and Drug Administration (USFDA), as per the media reports.

USFDA had issued a warning letter to the company’s unit in 2015. The unit was issued an establishment inspection report in which the US regulator did not clear the unit but pointed out areas of concern that the company needed to address.

As per media reports, the regulator has discussed a repeated instance of false or misleading statements given by the Duvvada unit staff to the USFDA.

The regulator also said the company had not taken appropriate action to correct out-of-specification results at the unit, the reports added. Dr. Reddy’s told investors in July 2017 that it expects a re-inspection of its Duvvada facility in Jan-Mar 2018.

The stock is trading at a price of Rs2351.20, down by 2.35% or Rs56.5, on BSE.

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