Zydus completes USFDA inspection at oncology plant with two minor observations, none related to data integrity
By Aditya Bhagchandani Published on June 18, 2025, 16:48 IST
Zydus Lifesciences Ltd has announced the successful conclusion of a Good Manufacturing Practices (GMP) follow-up inspection by the United States Food and Drug Administration (USFDA) at its oncology injectable manufacturing facility located at SEZ 1, near Matoda, Ahmedabad. The inspection was conducted over a 10-day period, from June 9 to June 18, 2025.
In a regulatory filing to the stock exchanges, the company stated, 'We wish to inform that the US Food and Drug Administration (USFDA) conducted a GMP follow-up inspection at the company's oncology injectable site situated at SEZ 1, near Matoda, Ahmedabad.'
The company further added that the inspection concluded with two observations, emphasizing that 'none of them were related to data integrity.' Zydus assured stakeholders that it is taking these observations seriously and is committed to addressing them promptly.
'The Company will closely work with the USFDA to address and respond to the observations in an expeditious manner,' the statement read.
This update has been provided in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Zydus also requested that this development be 'brought to the notice of the members of the exchange and the investors at large.'
The successful closure of the inspection without any data integrity issues is a positive sign for Zydus, reaffirming its compliance with global manufacturing standards in a critical therapeutic segment.
Ahmedabad Plane Crash
Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
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