The United States Food and Drug Administration (US FDA) conducted an unannounced inspection of the Company's manufacturing facility located at J4/2, Additional MIDC, Satara – 415 004, Maharashtra, India. The inspection period was from Monday, 5 October 2026 to Friday, 9 October 2026.
Upon conclusion of the inspection, the US FDA issued a Form 483 containing 1 observation. The company characterizes this observation as procedural in nature and clarifies that it does not relate to data integrity. The company expressed confidence in working closely with the regulator to successfully conclude the evaluation in a timely manner.
This inspection represents the first successful unannounced inspection for the Satara facility. The disclosure notes that the previous inspection for this site occurred in January 2023, which was the first ever US FDA inspection for the site, and for which the company had received prior intimation.
The company provided additional context regarding its regulatory inspection history. This would be the third successful unannounced US FDA inspection for the company in FY2026-27, following inspections of their Toronto (Canada) R&D facility in April 2026 and Pithampur (India) manufacturing facility in July 2026.
Additionally, the disclosure mentions that the company's recently acquired manufacturing facility in East Brunswick, New Jersey, USA was inspected by the US FDA in May 2026, just prior to the company's acquisition of that facility in July 2026.
The company committed to keeping the stock exchanges duly informed of any further updates on this subject.
Financial Impact
Financial impact not quantified in the disclosure.