HYDERABAD: Pharma major Dr Reddy’s laboratories on Thursday informed the bourses that it has received a Form 483 with nine observations from the US drug regulator, US Food & Drug Administration, for its biologics manufacturing facility at Bachupally in Hyderabad.
The company said it will be addressing these concerns raised by the US drug regulator within the specified time frame.
“We have been issued a Form 483 with nine observations, which we will address within the stipulated timeline,” Dr Reddy’s Labs said in a regulatory filing.
The USFDA inspectors issued the observations after a product-specific pre-approval inspection of the biologics facility in Bachupally.
The inspection was conducted by USFDA from October 4, 2023, October 12, 2023.
Dr Reddy’s scrip, which opened at Rs 5599.95 on the Bombay Stock Exchange on Thursday, closed 0.67% down or lost Rs 37.35 per share to close at Rs 5529.90 a share.
The company said it will be addressing these concerns raised by the US drug regulator within the specified time frame.
“We have been issued a Form 483 with nine observations, which we will address within the stipulated timeline,” Dr Reddy’s Labs said in a regulatory filing.
The USFDA inspectors issued the observations after a product-specific pre-approval inspection of the biologics facility in Bachupally.
The inspection was conducted by USFDA from October 4, 2023, October 12, 2023.
Dr Reddy’s scrip, which opened at Rs 5599.95 on the Bombay Stock Exchange on Thursday, closed 0.67% down or lost Rs 37.35 per share to close at Rs 5529.90 a share.
