Zydus Lifesciences receives four observations from USFDA following inspection at Himachal Pradesh facility

Zydus Lifesciences announced that its formulation manufacturing facility located in Baddi, Himachal Pradesh, has received four observations from the United States Food and Drug Administration (USFDA).

According to an exchange filing, the company stated that the USFDA concluded a surveillance inspection at the Baddi facility, which was conducted from 4 August to 13 August 2025. The inspection ended with four observations.

The company clarified that none of the observations were related to data integrity. Zydus added that it will work closely with the USFDA to address and resolve the observations expeditiously.

In a separate filing, the company also informed that the USFDA conducted a Pre-Approval Inspection (PAI) at its formulation manufacturing facility located in SEZ ? II, Ahmedabad. The inspection, which covered three products and general current Good Manufacturing Practices (cGMP), was conducted from 11 August to 13 August 2025. This inspection concluded with no observations, indicating a clean outcome.

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 shed 1% to Rs 1,170.90 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24.

The counter added 1.35% to end at Rs 1,002.40 on the BSE.

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