Dr Reddy’s Srikakulam unit clears US FDA audit

US FDA issues an EIR to DRL’s Srikakulam plant

The US Food and Drug Administration (US FDA) has cleared pharma major Dr Reddy’s Laboratories Ltd’s formulation Srikakulam Plant (SEZ) Unit I in Andhra Pradesh from its recent audit.

The Hyderabad-based company had received an Establishment Inspection Report (EIR) from the US FDA for the above-referred facility, the Bombay Stock Exchange was informed on Thursday.

"With regard to the audit of the company’s formulation Srikakulam Plant (SEZ) Unit I, Andhra Pradesh. The company has received an EIR from US FDA, for the above-referred facility," Dr Reddy’s said in a regulatory filing today.

US FDA issues an EIR to the establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.