Dr Reddy’s Faces FDA Form 483 at Biologics Facility, Plans to Address Observations

Dr Reddy’s Laboratories has received a Form 483 with five observations following a USFDA Pre-Approval Inspection (PAI) at its biologics facility in Bachupally, Hyderabad, conducted from September 4–12, 2025. The company has committed to addressing the observations within the stipulated timeframe and reaffirmed its adherence to global quality standards. This inspection follows a previous PAI in October 2023. The latest findings could impact regulatory clearances for upcoming biosimilar or biologic products, though no immediate operational disruption has been reported. Despite this, Dr Reddy’s reported strong Q1 FY26 results, with revenue rising to ₹8,542 crore and net profit reaching ₹1,417.8 crore. It has guided for double-digit revenue growth and stable margins for FY26. The company also expanded its portfolio by acquiring Janssen’s Stugeron brand from Johnson & Johnson for $50.5 million, covering 18 markets in Asia-Pacific and EMEA. The focus now remains on timely resolution of FDA concerns to maintain its credibility in the US and global regulated markets.