USFDA Issues Post-Application Action Letter to Dr Reddy's Biologics Unit
Hyderabad: Dr. Reddy's Laboratories Ltd has received a Post-Application Action Letter (PAAL) from the United States Food and Drug Administration (USFDA) following the regulator's review of the company's response to a Pre-Approval Inspection (PAI) conducted at its biologics manufacturing facility in Bachupally, Hyderabad.
In a regulatory disclosure, Dr. Reddy’s said the PAAL relates to the submission it made after the USFDA carried out the PAI, which the company had earlier disclosed on September 13, 2025.
The company stated that it will work closely with the USFDA and remains committed to addressing the queries outlined in the PAAL. No further details were provided on the specific observations or timelines at this stage.
A Post-Application Action Letter is issued by the USFDA to communicate outstanding questions or requests for additional information following an application review, including inspections, before a final regulatory decision is taken.
Dr. Reddy’s Laboratories, headquartered in Hyderabad, has a growing focus on biologics and complex therapies for global markets, including the United States. The company said it will keep stakeholders informed of any material developments in line with applicable regulatory requirements.
