Dr Reddy's Lab gets EIR from USFDA for Srikakulam facility

Dr Reddy's Laboratories announced that it has received the Establishment Inspection Report (EIR) on 4 March 2026 from the U.S. Food and Drug Administration (USFDA) for its formulations manufacturing facility located at Srikakulam, Andhra Pradesh.

The USFDA classified the inspection outcome as Voluntary Action Indicated (VAI) and confirmed that the inspection has been officially closed under 21 CFR 20.64(d)(3).

The inspection included both a Good Manufacturing Practice (GMP) review and a Pre-Approval Inspection (PAI) conducted at the companys FTO-SEZ PU01 facility. The company had earlier informed about the USFDA inspection on 12 December 2025.

Hyderabad-based Dr Reddys Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.

Dr Reddys Laboratories reported a 14.4% decline in consolidated net profit to Rs 1,209.8 crore despite a 4.4% jump in revenue to Rs 8,716.8 crore in Q3 FY26 over Q3 FY25.

The counter shed 0.91% to Rs 1,301.10 on the BSE.

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