Dr. Reddy's gets USFDA's Establishment Inspection Report for Andhra facility

Hyderabad-based drugmaker Dr. Reddy's Laboratories Ltd. has informed stock exchanges that its manufacturing facility in Srikakulam, Andhra Pradesh, has received a Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA).

The company said it received the Establishment Inspection Report (EIR) on October 20, 2025. The USFDA classified the inspection outcome as VAI and concluded that the inspection is officially closed.

Earlier, Dr. Reddy's had reported a Good Manufacturing Practices (GMP) inspection and a Pre-Approval Inspection (PAI) conducted by the USFDA at its formulations facility.

A Voluntary Action Indicated (VAI) status means that objectionable conditions or practices were found at the facility, but the agency (USFDA) is not prepared to take or recommend any administrative or regulatory action. It is lower than the Official Action Indicated (OAI) status, which means regulatory and / or administrative actions are recommended.

Shares of Dr. Reddy's Laboratories Ltd. settled 2.10% higher at ₹1,282.40 on Monday, though the stock is still down 6% so far in 2025.Read about our editorial guidelines and ethics policy