USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

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.