News
Dr Reddy?s Labs receives seven USFDA observations for Hyderabad facility
26-Jun-2026 | 09:26
Dr Reddy?s Laboratories announced that US Food and Drug Administration (USFDA) completed a Pre-License Inspection (PLI) at its biologics manufacturing facility in Bachupally, Hyderabad, conducted between 16th June to 25th June 2026.
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.
Powered by Capital Market - Live News