USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations
New Delhi: Zydus Lifesciences Limited has informed stock exchanges that the United States Food and Drug Administration (USFDA) has completed an inspection at the company's Unit-2 manufacturing plant at Ankleshwar, Gujarat, with the inspection concluding with three observations. The company clarified that there were no data integrity-related observations during the inspection.
In an intimation, Zydus Lifesciences stated that the USFDA inspection was carried out at the group’s Ankleshwar Unit-2 facility over a five-day period, from January 19, 2026 to January 23, 2026, and has now been formally closed.
The company further stated that it will work closely with the USFDA to address the observations expeditiously. Zydus emphasised that the absence of data integrity observations is a key aspect of the inspection outcome.
The disclosure was made as part of a press release titled “Closure of USFDA inspection at Zydus’ Unit-2 manufacturing plant at Ankleshwar”, which was submitted to the stock exchanges for the information of investors and members at large.
Zydus Lifesciences informed that the disclosure has been made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Zydus Lifesciences Limited, headquartered in Ahmedabad, Gujarat, stated that the inspection closure information forms part of its statutory disclosures under SEBI regulations and reflects the company’s continued engagement with global regulatory authorities.
