Dr. Reddy’s Laboratories has received a Post-Application Action Letter (PAAL) from the United States Food & Drug Administration (USFDA) for its biologics manufacturing facility in Bachupally, Hyderabad. The letter follows an inspection conducted in September 2025. The company is committed to working closely with the USFDA to address the queries specified in the PAAL and ensure compliance.
USFDA Communication
Dr. Reddy’s Laboratories has announced that it has received official communication from the United States Food & Drug Administration (USFDA) concerning its biologics manufacturing facility located in Bachupally, Hyderabad.
Details of the Letter
The communication is a Post-Application Action Letter (PAAL). The letter follows the Pre-Approval Inspection (PAI) by the USFDA conducted in September 2025. Dr. Reddy’s is taking steps to address the queries contained within this communication.
Company Statement
The company has stated that it will work closely with the USFDA to address all concerns and is committed to answering the queries outlined in the PAAL.
Source: BSE
