Dr. Reddy's Receives USFDA Form 483 with Three Observations

Key Event: USFDA Inspection

• The United States Food & Drug Administration (USFDA) completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at the company's FTO-SEZ Process Unit-02, located in Srikakulam, Andhra Pradesh.
• The inspection was conducted over a period of ten days, from July 20, 2026, to July 29, 2026.

Inspection Outcome

• The outcome of the inspection was the issuance of a Form 483.
• The Form 483 contains three observations.
• The company states it will address these observations within the stipulated timeline provided by the USFDA.

The disclosure, signed by K Randhir Singh (Company Secretary, Compliance Officer & Head-CSR), is dated July 29, 2026, and was submitted on the same day.