Sun Pharma on Monday announced that the US Food and Drug Administration (FDA) issued a Form-483 with eight observations for its Halol facility. The pharma major said that the observations followed a Good Manufacturing Practices (GMP) inspection conducted between June 2 and June 13.
“We hereby inform that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited’s Halol facility (Gujarat, India) from 02 June to 13 June 2025. At the conclusion of the inspection, the US FDA issued a Form-483, with 8 observations,” Sun Pharma said in a regulatory filing.
Halol is one of the key plants for Sun Pharma but has been under an import alert since December 2022. The company had earlier received a warning letter for the Halol plant.
Earlier on June 13, Sun Pharma had announced a significant leadership transition, appointing Kirti Ganorkar as the company’s managing director, effective September 1, 2025. Founder Dilip Shanghvi will step down from the role and continue as the Executive Chairman of the Board.
The company had said that this move marks the culmination of a “structured and forward-looking succession planning process” aimed at ensuring leadership continuity. The appointment is pending shareholder approval at the company’s next Annual General Meeting.
In May, the pharma company had released its fiscal fourth quarter results with a 19 per cent YoY growth in consolidated profit at Rs 2,153.93 crore against a profit of Rs 2,658.74 crore in the corresponding quarter of the previous financial year. It posted revenue from operations at Rs 12,958.84 crore, up 8 per cent on-year from Rs 11,982.90 crore reported during the fourth quarter of FY24. EBITDA for the quarter under review increased 22 per cent to Rs 3,716 crore.
Shares of Sun Pharma were down 0.56 per cent at 9:50 am at a trading price of Rs 1,679.20.