USFDA issues 4 observations for Zydus Jarod injectable manufacturing plant

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-09-06 06:09 GMT   |   Update On 2025-09-06 06:09 GMT
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Ahmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has issued four observations at the completion of an inspection at the group’s injectable manufacturing plant at Jarod, near Vadodara, Gujarat.

The inspection was conducted from 25th August to 5th September, 2025.
"There were no data integrity related observations. The Company will closely work with the USFDA to address the observations expeditiously," Zydus stated in a BSE filing.
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Zydus Lifesciences Ltd. is a 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.

Read also: Zydus, Synthon enter licensing, supply agreement for multiple sclerosis drug Ozanimod for US market

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