Earlier, the United States Food & Drug Administration (USFDA) had conducted a GMP and pre-approval inspection (PAI) at the R&D centre (Integrated Product Development Organisation or IPDO) in Bachupally, Hyderabad from 4 December 2023 to 8 December 2023. The agency had issued a Form 483 with three observations on 8 December 2023 to the facility.
Also, the US drug regulator conducted a routine current good manufacturing practice (cGMP) inspection at the formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad from 19 October to 27 October 2023. The facility was issued a Form 483 with ten observations on 28 October 2023.
The drug maker stated that both the inspections have received ?voluntary action indicated? (VAI) from the USFDA, indicating that the inspection is closed.
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 drug major's consolidated net profit increased 10.57% to Rs 1,378.9 crore on 6.57% rise in revenues to Rs 7,214.8 crore in Q3 FY24 over Q3 FY23.
The counter hit a life-time high of Rs 6,390 in today?s intraday session.
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