The regulator completed a pre-approval inspection at the site between September 4 and September 12, 2025.
In a filing to the stock exchanges, the company said it would address the observations within the stipulated timeline. The inspection follows an earlier review at the same facility in October 2023.
On Friday, shares of Dr Reddy’s closed 0.84 percent higher at ₹1,314 on the NSE.
Earlier this week, the Hyderabad-headquartered drugmaker announced it had entered into a definitive agreement with Janssen Pharmaceutica NV, an affiliate of Johnson & Johnson, to acquire the Stugeron portfolio for $50.5 million.
The deal covers 18 markets across Asia-Pacific and EMEA, with India and Vietnam identified as key growth markets. Stugeron, containing the antihistamine cinnarizine, is prescribed for vestibular disturbances and vertigo.
Dr Reddy’s reported revenue of ₹8,542 crore in the first quarter of FY26, compared to ₹7,672.7 crore a year earlier. The figure was above a CNBC-TV18 poll estimate of ₹8,676.4 crore.
Net profit stood at ₹1,417.8 crore, higher than last year’s ₹1,392 crore, though slightly below analyst expectations. EBITDA came in at ₹2,287 crore against the poll estimate of ₹2,201.6 crore.
The company has guided for double-digit topline growth and flat margins for the ongoing financial year.
