USFDA Issues Post-Application Action Letter to Dr Reddy's Biologics Unit

Published On 2026-01-10 16:59 GMT | Update On 2026-01-10 16:59 GMT

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.

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Farhat Nasim

Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA Issues Post-Application Action Letter to Dr Reddy's Biologics Unit

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