At the conclusion of the inspection, USFDA issued a Form-483 with seven observations. The company said it will address within the stipulated timeline.

Previously, the USFDA had conducted a Pre-Approval Inspection (PAI) at the same Hyderabad facility between 4 September and 12 September 2025, following which it had issued five observations.

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.

The company reported a 86.14% decline in consolidated net profit to Rs 220.9 crore on 11.51% drop in revenue from operations to Rs 7,546.4 crore in Q4 FY26 over Q4 FY25.

The counter advanced 1.63% to settle at Rs 1,350 on Thursday, 25th June 2026. The NSE and BSE remain closed today on account of Muharram.