Pharmaceutical major Dr Reddy's has informed the exchanges that the United States Food and Drug Administration (FDA) has issued seven observations to Bachupally Plant following an inspection.
The inspection was conducted between June 16 and June 25.
In an exchange filing following the market hours on Thursday, June 25, Dr Reddy's said, "The United States Food & Drug Administration (USFDA) today completed a Pre-License Inspection (PLI) at our biologics manufacturing facility in Bachupally, Hyderabad. The inspection was conducted between June 16 and June 25, 2026. We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline."
Prior to this, the pharma giant informed that the FDA had completed a Pre-Approval Inspection (PAI) at biologics manufacturing facility in Bachupally, Hyderabad. Following the inspection conducted from September 4, 2025 to September 12, 2025, the US drug regulator issued a Form 483 with five observations.
In Q4FY26, Dr Reddy's Laboratories Ltd's net profit plunged 86% YoY (year-on-year) to Rs 221 crore from Rs 1,593 crore in the year-ago period. The firm suffered impact from a Shelf Stock Adjustment ('SSA') related to lenalidomide of Rs 4,530 crore It also dealt with impairment of CAR-T assets and Eftilagimod Alfa of a total of Rs 27 crore and provisions related to VAT (value added tax) liability of Rs 14 crore.
The pharma company's revenue fell 12% YoY to Rs 7,546 crore from Rs 8,528 crore in the year-ago period. Meanwhile, Ebitda (earnings before interest, taxes, depreciation) and amortisation was 60% lower to Rs 981 crore from Rs 2,475 crore in the preceding fiscal.
Essential Business Intelligence, Sharp Market Insights, Practical Personal Finance Advice, Daily Fuel, Gold and Silver Prices and Latest Stories — On NDTV Profit.
