Dr. Reddy's USFDA Srikakulam Inspection Closed as VAI

Key Event and Update

Dr. Reddy's Laboratories Ltd. informs that the USFDA has classified the outcome of its Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection as 'Voluntary Action Indicated (VAI)'. The regulatory agency has concluded that the inspection is officially closed under the provision 21 CFR 20.64(d)(3).

Facility and Inspection Details

The inspection was conducted at the company's FTO-SEZ Process Unit-02, located in Srikakulam, Andhra Pradesh.

Chronology

This disclosure serves as a follow-up to the company's initial intimation regarding the commencement of the USFDA inspection, which was made to the exchanges on July 29, 2026.

Financial Impact

Financial impact not quantified in the disclosure.