Zydus Life Ankleshwar Unit-2 Gets Three USFDA Observations

Zydus Lifesciences Limited informed the exchanges that the United States Food and Drug Administration (USFDA) conducted an inspection at the group’s Unit-2 manufacturing plant at Ankleshwar, Gujarat. According to the regulatory filing, the inspection was conducted from January 19, 2026, to January 23, 2026, and concluded with three observations.

“There were no data integrity related observations,” said the company.  Zydus Lifesciences Limited will “closely work with the USFDA to address the observations expeditiously,” the company added.