In a regulatory filing, the company informed that the USFDA conducted a pre-approval and cGMP inspection of commercial manufacturing activities for the US market at the Bengaluru facilities from 10 February 2025 to 20 February 2025.
On conclusion of the inspection, the USFDA issued Form 483 with 5 (Five) observations.
"The company will work closely with USFDA and remains committed to addressing these observations comprehensively within the stipulated time," Syngene International said in a statement.
Syngene International is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors.
The company reported 17.58% increase in consolidated net profit to Rs 131.1 crore in Q3 FY25 as compared with Rs 111.5 crore in Q3 FY24. Revenue from operations jumped 10.57% YoY to Rs 943.7 core in Q3 FY25.