Dr. Reddy’s biologics unit gets U.S. FDA queries

Dr. Reddy’s Laboratories has been issued a post-application action letter (PAAL) with queries related to its biologics manufacturing facility in Hyderabad by the U.S. Food and Drug Administration.

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The letter follows the pre-approval inspection of the facility in September 2025 and issue of Form 483 with five observations by the U.S. FDA. The company had consequently submitted its response. “The company will work closely with the U.S. FDA and is committed to addressing the queries specified in the PAAL,” Dr. Reddy’s said in a filing on Saturday (January 10, 2026).

The September development was pursuant to an October 2023 inspection when the biologics facility received a Form 483 with nine observations from the U.S. FDA on completion of a product specific PAI.