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Dr Reddy's tumbles on USFDA inspection report, recovers

The stock cut down initial losses and was trading 2.22 per cent down at Rs 2,121.

Updated: Feb 26, 2018, 03.47 PM IST
Dr Reddy’s Laboratories tanked as much as 4 per cent in early trade on Monday after the pharma major on Sunday said it has received the establishment inspection report (EIR) from the USFDA for its Srikakulam plant. However, the stock recovered losses and eventually ended the day 1.15 per cent higher at Rs 2,194.15.

The company, without going into the content of the EIR, said the USFDA has maintained OAI (Official Action Indicated) status at its API manufacturing plant in Srikakulam.

The US drug regulator has sought more details from the company.

“The FDA has asked us for more details. We are providing those details and continuing to engage with the FDA for resolution of pending issues,” Dr Reddy’s said in a regulatory filing.

An OAI status is equivalent to finding objectionable conditions at the audit site and is also indicative of regulatory and/or administrative sanctions.

The USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.

The scrip opened the day at Rs 2,080 and scaled high and low of Rs 2,209.45 and Rs 2,080, respectively.

Dr Reddy’s had hit 52-week high of Rs 2,948 on March 1, 2017, and 52-week low of Rs 1,901.65 on August 11, 2017.
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