The inspection concluded on 27 March 2026, following which the company received a Form 483 with one observation. According to the company, the observation is procedural in nature.
The company further stated that it will submit its corrective and preventive action (CAPA) plan along with compliance within the stipulated timeline prescribed by the US FDA.
Aarti Pharmalabs (APL) is an established, internationally recognized manufacturer of active pharmaceutical ingredients (APIs), pharmaceutical intermediates, new chemical entities (NCEs), and xanthine derivatives based in India.
The company reported a 35.2% decline in consolidated net profit to Rs 47.96 crore, despite a 19.6% decline in revenue from operations to Rs 432.27 crore in Q3 FY26 compared with Q3 FY25.
The counter slipped 1.99% to Rs 597 on the BSE.