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Zydus Lifesciences faces six US FDA observations after an API plant inspection in Gujarat.
Zydus Lifesciences, an Indian pharmaceutical firm, received six observations from the US Food and Drug Administration (USFDA) following a recent inspection of its API manufacturing unit in Gujarat.
The inspection took place from April 21-25, 2025.
The company stressed that none of the observations were related to data integrity and expressed confidence in resolving them quickly.
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Zydus Lifesciences enfrenta seis observaciones de la FDA de los Estados Unidos después de una inspección de una planta de API en Gujarat.