Key Event Details

United States Food & Drug Administration (USFDA) completed a Pre-License Inspection (PLI) at Dr. Reddy's biologics manufacturing facility located in Bachupally, Hyderabad. The inspection was conducted between June 16, 2026 and June 25, 2026.

Inspection Outcome

The company has been issued a Form 483 with seven observations. Dr. Reddy's will address these observations within the stipulated timeline provided by USFDA.

Historical Context

This inspection is in continuation of earlier inspections and corresponding disclosures made to the stock exchanges on October 12, 2023 and September 13, 2025.

Financial Impact

Financial impact not quantified in the disclosure.