The US drug regulator had conducted a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of the company located in Vema, Goa, India, from 9 April 2024 to 17 April 2024.
On conclusion of the inspection, the company has received 5 inspectional observations in Form 483. There is no data integrity observation.
"The company will work closely with the USFDA and is committed to address these observations comprehensively within the stipulated time,” Marksans Pharma said in a statement.
Marksans Pharma is primarily engaged in the business of research, manufacture, marketing and sale of pharmaceutical formulations.
The company’s consolidated net profit jumped 33.69% to Rs 83.29 crore in Q3 FY24 as compared with Rs 62.30 crore in Q3 FY23. Revenue from operations increased 22.15% YoY to Rs 586.12 crore in Q3 FY24.