Date: October 14, 2026
Other Operational / Legal / Strategic Disclosures
The United States Food and Drug Administration (USFDA) completed a Pre-Approval Inspection (PAI) at the company's FTO-9 manufacturing facility located in Visakhapatnam, Andhra Pradesh, India. The inspection was conducted over a two-day period from October 8, 2026, to October 9, 2026. The outcome of the inspection was the issuance of a Form 483, which contained three observations. The company states that it will address these observations within the stipulated timeline.