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 inspection was conducted from 9th of June to 18th of June 2025.
The inspection is closed with 2 observations and none of them were related to data integrity. The company will closely work with the USFDA to address and respond to the observations in an expeditious manner.
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