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The United States Food and Drug Administration (USFDA) has issued five observations on a manufacturing unit of pharma major Dr Reddy’s Laboratories Ltd here.
In a filing to the Bombay Stock Exchange (BSE), Hyderabad-based Dr Reddy’s said the company has been issued a Form 483 with five observations by the US Regulator after completion of the audit of its Active Pharmaceutical Ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad.
“We will address them comprehensively within the stipulated timeline,” Dr Reddy’s said. It however did not provide any details about the observations made by the regulator.
As per the USFDA norms, Form 483 notifies the company’s management of objectionable conditions.
Dr Reddy’s scrip lost 0.77 per cent on the BSE on Friday to end at Rs 2331.60.
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