Dr Reddy's Labs Hyderabad facility gets 9 observations from US drug regulator; shares fall

Shares of Dr Reddy's Laboratories slipped as much as 2.3 per cent in Friday's trading session on BSE, touching the day's low at Rs 5400.05 apiece. Selling pressure in the stock can be attributed to the US Food and Drug Administration (USFDA) issuing nine observations for the company's biologics manufacturing facility at Bachupally in Hyderabad.

At around 12:42 p.m., shares of the pharmaceutical company traded 0.85 per cent or Rs 46.8 lower at Rs 5,483.1 apiece. The stock fell for the second straight day and the market capitalisation of the company stood at Rs 91,737.16 crore.

"The USFDA today completed a product-specific Pre-Approval Inspection (PAI) at our biologics manufacturing facility in Bachupally, Hyderabad. The inspection was conducted from October 4, 2023, to October 12, 2023. We have been issued a Form 483 with nine observations," the regulatory filing read.

The company said that it would address the observations within the stipulated timeline.

Dr Reddy's Laboratories will release its September quarter Q2FY24 numbers on October 27, 2023.

Dr Reddy's Financial performance in Q1

Dr Reddy's Laboratories registered an 18 per cent increase in consolidated profit after tax at Rs 1,405 crore in the June quarter, fuelled by US generics and strong performance in Russia. 

The consolidated total revenue from operations was Rs 6,757.9 crore, compared to Rs 5,232.9 crore in the year-ago period. Total expenses in the first quarter of the current fiscal (Q1) were higher at Rs 5,086.2 crore compared to Rs 4,628.2 crore in the same period a year ago.

The company said its global generics posted a revenue of Rs 6,010 crore in Q1. However, India's revenue was down 14 per cent at Rs 1,150 crore.

Dr Reddy's share price performance 

Since January, Dr Reddy's Laboratories shares have soared more than 30 per cent against Nifty 50's rise of over 8 per cent in the same period.

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