The U.S. Food and Drug Administration (USFDA) issued Form 483 with two observations after an inspection at Dr. Reddy's Laboratories' formulation manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh.
The pharma major said that it will address to the observations within the stipulated timeline. The pre approval inspection (PAI) was conducted from 30 June 2022 to 7 July 2022.Dr Reddy's Laboratories is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.
The pharma major's consolidated net profit tumbled 82.6% to Rs 97 crore on a 15% increase in revenue from operations to Rs 5436.80 crore in Q4 FY22 over Q4 FY21.
Shares of Dr Reddy's Laboratories fell 0.03% to Rs 4,337.25 on the BSE.
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