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 company’s FTO-SEZ PU01 facility. The company had earlier informed about the USFDA inspection on 12 December 2025.
Hyderabad-based Dr Reddy’s Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.
Dr Reddy’s 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.