Dr. Reddy’s Labs. , Photo courtesy: The Hindu
Dr. Reddy’s Laboratories has been issued a Post-Application Action Letter (PAAL) by the US Food and Drug Administration with queries related to its biologics manufacturing facility in Hyderabad.
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This letter follows a pre-approval inspection of the facility in September 2025 and the issuance of a Form 483 with five comments by the US FDA. After this the company filed its reply. “The company will work closely with the US FDA and is committed to addressing the questions specified in the PAAL,” Dr Reddy’s said in a filing on Saturday (January 10, 2026).
The September development was in accordance with the October 2023 inspection when the biologics facility received a Form 483 with nine comments from the US FDA on completion of the product specific PAI.
published – January 10, 2026 08:36 PM IST