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USFDA seeks voluntary action at Dr Reddy's Andhra Pradesh unit

BusinessToday.In     February 16, 2020

Drug major Dr Reddy's Laboratories on Sunday said the United States Food and Drug Administration (USFDA) has asked it to initiate voluntary action at its Duvvada facility in Andhra Pradesh.

"With regard to the audit of our Formulations Manufacturing Plant at Duvvada, Visakhapatnam, we would like to inform you that we have been notified by the USFDA, that the inspection classification of the above-referred facility is determined as Voluntary Action Initiated," Dr Reddy's Laboratories said in a filing to the Bombay Stock Exchange.

Last week, the audit of Dr. Reddy's Formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh, was completed with zero observation by the US FDA.

Earlier on November 5, 2015,USFDA had issued a warning letter to Dr Reddy's over deviations with current good manufacturing practices at its active pharmaceutical ingredients (API) manufacturing facilities in Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as over violations at its oncology formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. Of these three manufacturing facilities, API manufacturing facility at Miryalaguda and oncology formulation manufacturing facility at Duvvada received Establishment Inspection Reports from the USFDA in June 2017 and February 2019, respectively.

In a separate development, Dr Reddy's Laboratories on 12 February announced to acquire Wockhardt's select divisions of branded generics business in India and a few other international territories of Nepal, Sri Lanka, Bhutan and Maldives for a consideration of Rs 1,850 crore.

Ahead of announcement, shares of Dr Reddy's Laboratories closed Friday's trade at Rs 3,307.50 apiece, down 0.55 per cent, on the BSE.

By Chitranjan Kumar

Also Read: Dr Reddy's inks Rs 1,850-crore deal with Wockhardt; to acquire 62 brands & Baddi unit

Also Read: Dr Reddy's awaits USFDA inspection report for Srikakulam facility after a 'good' December quarter

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