Dr Reddy's shares fall as USFDA flags Hyderabad plant with 5 observations

Dr Reddy's shares fell on Monday after the USFDA issued a Form 483 with five observations at its Hyderabad plant inspection

Shares of Dr Reddy's Laboratories Ltd. fell nearly 2 per cent on Monday after the United States Food & Drug Administration (USFDA) issued a Form 483 with five observations at its Hyderabad plant inspection. 

 

The pharma major's stock fell as much as 1.84 per cent during the day to ₹1,292.5 per share, the biggest intraday fall since September 2 this year. The stock pared losses to trade 1.2 per cent lower at ₹1,300 apiece, compared to a 0.02 per cent decline in Nifty 50 as of 12:25 PM. 

 

The counter has fallen 7 per cent this year, compared to a 6 per cent advance in the benchmark Nifty 50. Dr Reddy's has a total market capitalisation of ₹1.08 trillion. 

Dr Reddy's receives observations from USFDA

The United States Food & Drug Administration (USFDA) completed a Pre-Approval Inspection (PAI) at the company's biologics manufacturing facility in Bachupally, Hyderabad, according to an exchange filing on Saturday. The inspection was carried out between September 4 and September 12, 2025. 

 

Following the inspection, the facility received a Form 483 with five observations, which the company said it will address within the stipulated timeline. The development follows an earlier inspection disclosed to the stock exchanges on October 12, 2023, the statement added. 

 

Earlier this month, Dr Reddy's said that the USFDA has completed a good manufacturing practices (GMP) inspection at its active pharmaceutical ingredient (API) manufacturing facility in Mirfield, West Yorkshire, UK. The inspection was conducted from 1 September to 5 September 2025 and concluded by issuing a Form-483 with seven observations.  Track Stock Market LIVE Updates

Allotment of employee stock options

In another exchange filing on Monday, the pharma major said it has allotted 6,475 equity shares of ₹1 each, fully paid-up, on September 15, 2025, to eligible employees under the Dr. Reddy's Employees ADR Stock Options Scheme, 2007. The shares have been allotted at nil premium, it added. 

 

Following this, the total issued shares of the company stand at 83,46,14,760, and the total issued share capital stands at ₹83.46 crore. 

Dr Reddy Lab Q1 results 

The Hyderabad-based fiem reported a consolidated net profit of ₹1,417 crore in the first quarter of financial year 2026 (Q1FY26), a 2 per cent increase from ₹1,392 crore profit logged in the same quarter of previous year. The company clocked its highest ever quarterly revenue at ₹8,545 crore, up by 11 per cent year-on-year (Y-o-Y) from ₹7,672 crore.

 

The increase in the profit and revenue was attributed to new product launches and the price hikes taken in the quarter.