The United States Food and Drug Administration (US FDA) conducted a Pre Approval Inspection (PAI) at the company's Indore plant from 27th June 2022 to 1st July 2022.

The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at the said plant. There is no data integrity observation.

The PAI is part of the routine business operations and the Company is committed to addressing these observations and will submit its response to US FDA within the stipulated time.