Dr Reddy's gains nearly 3% post completion of USFDA inspection at AP unit
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Dr Reddy's Laboratories surged 2.6 per cent to hit a fresh 52-week high at Rs 5,360 in intra-day deals on Thursday after the company received 'clean chit' post the United States Food & Drug Administration (USFDA) routine inspection at the Andhra Pradesh (AP) facility.
At 10:40 AM, the stock quoted at Rs 5,346, up 2.4 per cent on the BSE as against a 0.1 per cent decline on the BSE benchmark index.
The stock has rallied over 19 per cent since the end of May. In comparison, the NSE Nifty 50 has gained 7 per cent during the same period.
"The USFDA completed a Pre-Approval Inspection (PAI) and a routine GMP inspection at our API manufacturing facility in Srikakulam, Andhra Pradesh. The inspection was conducted from July 10 to July 19. The inspection closed with zero observations and a classification of No Action Indicated (NAI).” the company said in a release to the exchanges.
Last week, Dr Reddy's announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate 'DRL_RI' was accepted for a substantive review by the USFDA.
This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), the company informed.
In January 2023, Dr. Reddy's had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, 'DRL_RI', for filing in highly regulated markets such as the United States, European Union, and other regions.
That apart, the pharma major has entered into an agreement with TEQ Green Power XI for accessing renewable power through solar and wind power plants through (Inter-State Transmission System) ISTS under captive structure O2 Power SG. Dr Reddy's and TEQ Green Power XI will invest in SPV in the ratio of 26:74.
The company is scheduled to announce its June quarter results on July 26.
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