US FDA Issues Form 483 With Five Observations at Dr Reddy’s Biologics Facility

15 Sep 2025 , 11:10 AM

Dr Reddy’s Laboratories Ltd. said on Friday that the US Food and Drug Administration (US FDA) has issued a Form 483 with five observations following an inspection of its biologics manufacturing facility at Bachupally, Hyderabad.

The inspection, conducted between September 4 and September 12, 2025, was a pre-approval review. In a stock exchange filing, the company said it will respond to the regulator within the stipulated timelines. The same facility was inspected by the US FDA earlier in October 2023.

Separately, the Hyderabad-based drugmaker this week announced a deal with Janssen Pharmaceutica NV, an affiliate of Johnson & Johnson, to acquire the Stugeron portfolio for $50.5 million. The agreement covers 18 markets across Asia-Pacific and EMEA, with India and Vietnam identified as key growth regions. Stugeron, which contains cinnarizine, is commonly prescribed for vestibular disorders and vertigo.

Financially, Dr Reddy’s reported first-quarter FY26 revenue of ₹8,542 crore, up from ₹7,672.7 crore in the same period last year. Net profit rose to ₹1,417.8 crore versus ₹1,392 crore a year earlier. EBITDA stood at ₹2,287 crore.

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