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Dr Reddy's Laboratories Ltd has received a Form 483 from the United States Food & Drug Administration (US FDA) following an inspection at its formulations facility in Srikakulam, Andhra Pradesh.
The inspection, which was a combination of Good Manufacturing Practices (GMP) review and a Pre-Approval Inspection (PAI), was conducted from December 4 to December 12, 2025. The US FDA issued five observations during the inspection.
The company stated that it will address the observations within the stipulated timeline. The formulations facility under review is located at FTO-SEZ PU01 in Srikakulam, Andhra Pradesh.
The shares of Dr Reddy's Laboratories ended 0.5% in the green in the session on Friday. The stock has fallen over 6% in the year so far.
This development comes days after Dr Reddy’s Laboratories SA, a wholly owned subsidiary of the company, entered into a strategic collaboration and exclusive licensing agreement with Immutep SAS to develop and commercialise Eftilagimod Alfa (efti) across multiple global markets.
The Hyderabad-based drug major reported a 7.3% year-on-year rise in net profit of ₹1,347 crore for the September quarter (Q2 FY26). The company’s revenue increased 9.8% YoY to ₹8,828 crore, while EBITDA fell 3.2%.
Also Read: KEC International bags ₹1,150 crore orders, clinches largest India T&D contract
The inspection, which was a combination of Good Manufacturing Practices (GMP) review and a Pre-Approval Inspection (PAI), was conducted from December 4 to December 12, 2025. The US FDA issued five observations during the inspection.
The company stated that it will address the observations within the stipulated timeline. The formulations facility under review is located at FTO-SEZ PU01 in Srikakulam, Andhra Pradesh.
The shares of Dr Reddy's Laboratories ended 0.5% in the green in the session on Friday. The stock has fallen over 6% in the year so far.
This development comes days after Dr Reddy’s Laboratories SA, a wholly owned subsidiary of the company, entered into a strategic collaboration and exclusive licensing agreement with Immutep SAS to develop and commercialise Eftilagimod Alfa (efti) across multiple global markets.
The Hyderabad-based drug major reported a 7.3% year-on-year rise in net profit of ₹1,347 crore for the September quarter (Q2 FY26). The company’s revenue increased 9.8% YoY to ₹8,828 crore, while EBITDA fell 3.2%.
Also Read: KEC International bags ₹1,150 crore orders, clinches largest India T&D contract
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