Dr Reddy's shares fall 3% as pharma major receives 7 observations from USFDA; check details

"The US Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," DRL said in a regulatory filing.

The company added that the inspection was conducted from November 13-19, 2024.

"We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said.

As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

For the quarter ended September 30, 2024 (Q2 FY25), Dr Reddy's reported a 9.35% decline in its consolidated net profit to ₹1,341.5 crore for the second quarter ended September 2024.

DRL had posted a net profit of ₹1,480 crore in the July-September quarter a year ago.

However, its revenue increased 16.51% to ₹8,016.2 crore in the September quarter from ₹6,880.2 crore in the year-ago period.

"Year-on-year growth was primarily driven by growth in global generics revenues. QoQ growth was primarily driven by global generics revenues in emerging markets, India, and Europe, as well as PSAI," DRL said in its earnings statement.

Its total operating expenses grew 34.3% to ₹3,021.8 crore in Q2 FY25.

Its Co-Chairman and MD, GV Prasad, said, "We delivered another good quarter and maintained the growth momentum across businesses. We made progress on our future growth drivers, operationalised our venture with Nestle, and completed the acquisition of Nicotinell and related brands".

DRL's revenue from pharmaceutical services and active ingredients rose 16.76% to ₹1,103 crore.