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Dr. Reddy's Receives USFDA Post-Application Action Letter for Hyderabad Facility
Dr. Reddy's Laboratories Limited
January 10, 2026, 02:04 PM
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Dr. Reddy's Laboratories Limited has received a Post-Application Action Letter (PAAL) from the United States Food & Drug Administration (USFDA) concerning its biologics manufacturing facility in Bachupally, Hyderabad. This follows a Pre-Approval Inspection (PAI) conducted by the USFDA and the subsequent submission of a response by the company.
The company has stated its commitment to working closely with the USFDA to address the queries raised in the PAAL. Further details on the specific nature of the queries or the timeline for resolution were not provided in this announcement.
This update is in relation to the intimation previously provided on September 13, 2025, regarding the PAI at the said facility.
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