Shares of Dr. Reddy’s Laboratories slipped 1.65% to ₹1,295 on Monday, September 15, after the company confirmed that the US Food & Drug Administration (USFDA) issued a Form 483 with five observations for its biologics manufacturing facility in Bachupally, Hyderabad.
The Pre-Approval Inspection (PAI) was conducted between September 4 and September 12, 2025, concluding with the issuance of the observations. The company said it will address the regulator’s concerns within the stipulated timeline.
This comes against the backdrop of a previous inspection review at the same facility in October 2023, highlighting the site’s ongoing scrutiny.
A Form 483 is issued when inspectors identify practices that may indicate violations of the Food, Drug, and Cosmetic Act. Companies are required to provide corrective action responses to avoid regulatory escalations.
Dr. Reddy’s emphasized its commitment to working closely with the USFDA to resolve the issues and reaffirmed its focus on compliance and quality standards.
At the current price, Dr. Reddy’s commands a market capitalization of ₹1.08 lakh crore and trades in a 52-week range of ₹1,020–₹1,405.90.
