The inspection was conducted over a 12-day period, from 25th August to 5th September 2025, and concluded with four observations. The company clarified that none of the observations relate to data integrity.
Zydus stated that it will work closely with the USFDA to address and resolve the observations in an expeditious manner.
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company’s consolidated net profit rose 3.3% to Rs 1,466.80 crore on 7% rise in revenue from operations to Rs 6,467 crore in Q1 FY26 over Q1 FY25.
Shares of Zydus Lifesciences rose 0.21% to close at Rs 1,014.15 on Friday, 05 September 2025.