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(26 Apr 2025, 11:02)

Zydus Life gets 6 observations from USFDA for API plant

Zydus Lifesciences announced the closure of a routine surveillance inspection conducted by the U.S. Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredients (API) manufacturing facility in Dabhasa, Gujarat.


The inspection, which ran from 21 to 25 April 2025, culminated with six observations issued by the US drug regulator. The company confirmed that none of the observations pertained to data integrity — a key area of concern in pharmaceutical compliance.

Zydus Lifesciences expressed confidence in addressing the observations "expeditiously," signaling that the company remains committed to maintaining regulatory standards and ensuring continued compliance.

Zydus Lifesciences is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 17.95% YoY to Rs 5,123.50 crore during the quarter.


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