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Hot Pursuit News

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(19 Jun 2025, 09:50)

Zydus Life Matoda facility receives two observations from USFDA after inspection

Zydus Lifesciences announced that its oncology injectable manufacturing facility located at SEZ 1 near Matoda, Ahmedabad, has received two observations from the United States Food and Drug Administration (USFDA) following a recent inspection.


In a regulatory filing, the company confirmed that the USFDA conducted a follow-up inspection focused on good manufacturing practices (GMP) from 9 June to 18 June 2025. Upon conclusion of the inspection, the US health regulator issued two observations.

Zydus clarified that the observations are not related to data integrity. The company further stated that it will work closely with the USFDA to address the issues raised and will submit its response within 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 shed 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24.

The counter shed 0.40% to Rs 954 on the BSE.

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