Zydus gets 2 USFDA observations for Ahmedabad oncology injectable site

Ahmedabad: Zydus Lifesciences has announced that the US Food and Drug Administration (USFDA) has issued two observations for the company’s oncology injectable site situated at SEZ 1, near Matoda, Ahmedabad.

The GMP follow-up inspection was conducted from 9
th of June to 18th of June 2025.
“The inspection is closed with 2 observations and none of them were related to data integrity,” Zydus stated in a BSE filing.
“The Company will closely work with the USFDA to address and respond to the observations in
an expeditious manner,” the company added.
Read also: USFDA inspection: Zydus gets EIR for Dabhasa API manufacturing facility

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.

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