USFDA10 Jan 2026, 07:41 pm
Dr Reddys Laboratories Receives USFDA's Post-Application Action Letter for Biologics Manufacturing Facility
AI Summary
Dr Reddys Laboratories Ltd. has received a Post-Application Action Letter (PAAL) from the United States Food & Drug Administration (USFDA) in relation to the response submitted for the Pre-Approval Inspection (PAI) at their biologics manufacturing facility in Bachupally, Hyderabad. The company is committed to addressing the queries specified in the PAAL and will work closely with the USFDA.
Key Highlights
- Dr Reddys Laboratories has received a Post-Application Action Letter (PAAL) from the USFDA
- The PAAL is in relation to the Pre-Approval Inspection (PAI) at their biologics manufacturing facility in Bachupally, Hyderabad
- The company is committed to addressing the queries specified in the PAAL
- Dr Reddys Laboratories will work closely with the USFDA
- This disclosure is made under Regulation 30 of SEBI (LODR) Regulations, 2015