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Zydus Lifesciences Faces USFDA Scrutiny: Six Observations at Gujarat API Unit Unveiled

USFDA Inspection Reveals Six Observations at Zydus Lifesciences' Gujarat Facility

Zydus Lifesciences announced on Saturday that its active pharmaceutical ingredient (API) manufacturing facility in Dabhasa, Gujarat, received six observations from the US Food and Drug Administration (USFDA) following a surveillance inspection conducted between April 21 and April 25, 2025.

Key Highlights:

The company emphasized that none of the observations were related to Data Integrity, showcasing confidence in addressing the findings promptly. This development comes as Zydus Lifesciences shares experienced a downturn, closing 2.45% lower on the National Stock Exchange.

Zydus Lifesciences receives 6 observations from USFDA for Gujarat API unit

Investors and stakeholders are keenly watching the company's next steps as it navigates through these regulatory observations, with the stock price reflecting the market's immediate reaction.