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 company's 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.Powered by Capital Market - Live

Dr Reddys Laboratories Ltd gained for a third straight session today. The stock is quoting at Rs 7070.4, up 1.51% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.12% on the day, quoting at 24728.5. The Sensex is at 80764.15, down 0.05%. Dr Reddys Laboratories Ltd has gained around 4.42% in last one month. Meanwhile, Nifty Pharma index of which Dr Reddys Laboratories Ltd is a constituent, has gained around 9.29% in last one month and is currently quoting at 22374.25, up 0.83% on the day. The volume in the stock stood at 2.77 lakh shares today, compared to the daily average of 3.85 lakh shares in last one month. The benchmark August futures contract for the stock is quoting at Rs 7076.65, up 1.59% on the day. Dr Reddys Laboratories Ltd is up 19.32% in last one year as compared to a 27.49% jump in NIFTY and a 47.43% jump in the Nifty Pharma index.The PE of the stock is 28.21 based on TTM earnings ending June 24.Powered by Capital Market - Live

Dr Reddys Laboratories has received the Establishment Inspection Report (EIR) for its formulations manufacturing facilities (FTO-7 & FTO-9) in Duvvada, Visakhapatnam. The USFDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is closed under 21 CFR 20.64(d)(3).Powered by Capital Market - Live

Dr Reddys Laboratories has allotted 29,790 equity shares of Rs.5/- each underlying 29,790 ADRs pursuant to Dr. Reddy's Employees ADR Stock Option Scheme, 2007.Powered by Capital Market - Live

Dr. Reddy's Laboratories announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI') in European markets. Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP). DRL_RI is being developed as a biosimilar of MabThera' (Rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. ITUXREDI' / DRL_RI (rituximab) is a proposed biosimilar to reference medicinal product MabThera' and the intended indications are the same as those currently approved for MabThera': Non-Hodgkin's Lymphoma (NHL); Chronic Lymphocytic Leukaemia (CLL); Rheumatoid Arthritis (RA); Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA); Pemphigus Vulgaris (PV). Powered by Capital Market - Live