Dr. Reddy’s facility in Andhra Pradesh gets 2 U.S. FDA observations
Dr. Reddy’s Laboratories received two observations from the U.S. FDA following an inspection of its manufacturing facility in Pydibhimavaram, Andhra Pradesh. The company stated it will address these findings within the required timeframe.
Why it matters
Regulatory observations can impact pharmaceutical export operations and investor confidence in major drug manufacturers.
The U.S. Food and Drug Administration (U.S. FDA) has issued two observations to a manufacturing facility of Dr. Reddy’s Laboratories in Andhra Pradesh.
A Form 483 with the two observations was issued by the U.S. FDA on completion of a pre-approval inspection (PAI) at the company’s FTO-11 manufacturing facility in Pydibhimavaram, Andhra Pradesh. The inspection was conducted from October 5-7. The company will address the observations within the stipulated timeline, Dr. Reddy’s said in a filing on Thursday.
The drugmaker’s shares closed 1.86% lower at ₹1,180 on the BSE.
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