USFDA Issues EIR to Dr Reddy's Srikakulam Facility

Regulatory approvals of international authorities are still paramount to the Indian pharmaceutical exporters, particularly in building compliance credibility and maintaining international market access. In this regard, the Laboratories of Dr. Reddy's have been provided with the Establishment Inspection Report (EIR) at the facility of manufacturing formulations owned by the company in Srikakulam, Andhra Pradesh.

The company reported that it had passed a regulatory inspection by the USFDA and subsequently, it was granted the EIR. The result of the inspection has been declared as Voluntary Action Indicated (VAI), and the agency has verified that the inspection has been officially closed as stated in 21 CFR 20.64(d) (3).

The inspection included a Good Manufacturing Practice (GMP) inspection as well as a Pre-Approval Inspection (PAI) in the FTO-SEZ PU01 plant of the company. The company had earlier announced the USFDA inspection on 12 December 2025.

Also Read: Dr. Reddy's Leads with Abatacept Biosimilar Filing 

The regulatory maturity is deemed important to the manufacturing processes of the company, because the compliance results of the USFDA regulatory processes usually affect the export channel of pharmaceutical formulations and controlled market approvals.

Dr. Reddy's Laboratories is an international pharmaceutical corporation based in Hyderabad and has a comprehensive product range that includes active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars, and over-the-counter (OTC) products.