4 months ago
2
Dr. Reddy’s Laboratories has been issued a post-application enactment missive (PAAL) with queries related to its biologics manufacturing installation successful Hyderabad by the U.S. Food and Drug Administration.
Also Read | Dr. Reddy’s Srikakulam works gets VAI tag from U.S. FDA
The missive follows the pre-approval inspection of the installation successful September 2025 and contented of Form 483 with 5 observations by the U.S. FDA. The institution had consequently submitted its response. “The institution volition enactment intimately with the U.S. FDA and is committed to addressing the queries specified successful the PAAL,” Dr. Reddy’s said successful a filing connected Saturday (January 10, 2026).
The September improvement was pursuant to an October 2023 inspection erstwhile the biologics installation received a Form 483 with 9 observations from the U.S. FDA connected completion of a merchandise circumstantial PAI.
