Zydus gets USFDA EIR for Ahmedabad oncology injectable manufacturing facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-09-22 05:21 GMT   |   Update On 2025-09-22 05:21 GMT
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Ahmedabad: Zydus has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for a GMP follow-up inspection conducted at its oncology injectable facility located at SEZ1, Ahmedabad.

The EIR has classified the facility as Voluntary Action Indicated (VAI).

The facility was inspected from 9th to 18th June 2025. 
The facility was earlier classified as an Official Action Indicated (OAI) in June 2024 which is now revised to Voluntary Action Indicated (VAI).
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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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