Dr Reddy’s Laboratories said that the US drug regulator has issued Form 483, with three observations after inspecting its Andhra Pradesh manufacturing facility.
According to the exchange filing the United States Food & Drug Administration (USFDA) has completed a product-specific Pre-Approval Inspection (PAI) at its formulations manufacturing facility in Srikakulam, Andhra Pradesh.
The said inspection was conducted from 19 August 2024 to 23 August 2024. Following the inspection, the USFDA has issued a Form 483 with three observations. The company has committed to addressing these observations within the stipulated timeline.
Dr Reddy’s Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.
The companys consolidated net profit shed marginally to Rs 1,392.40 crore in Q1 FY25 as against 1,405 crore posted in Q1 FY24. However revenue from operations jumped 13.9% YoY to Rs 7,672.70 crore in Q1 FY25.
The scrip shed 0.28% to settle at Rs 6,953.20 on Friday, 23 August 2024.
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First Published: Aug 24 2024 | 2:50 PM IST
