Zydus Lifesciences Gets Six US FDA Observations For Dabhasa Unit

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By BasisPoint Insight

April 29, 2025 at 1:40 AM IST

Zydus Lifesciences Ltd. on Saturday said it has received six observations from the US Food and Drug Administration for its active pharmaceutical ingredient manufacturing unit in Dabhasa, Gujarat. In a stock exchange filing the company informed that none of the observations were related to data integrity.

The US FDA conducted the inspection of the Dabhasa unit from Monday to Friday, and the company is confident of addressing the observations in a timely manner, it added.