The inspection took place from April 16 to April 24, 2025, at the subsidiary's manufacturing facility in Farmingdale, New York.
At the end of the inspection, the subsidiary received one observation, documented in the USFDA's Form 483. Notably, the inspection did not raise any concerns regarding data integrity.
Marksans Pharma confirmed that it will work closely with the USFDA to address the observation within the prescribed timeline.
Marksans Pharma is engaged in the research, manufacturing & marketing of generic pharmaceutical formulations in the global markets. The company's manufacturing facilities are approved by several leading regulatory agencies including USFDA, UKMHRA, and Australian TGA. The company's robust product portfolio spreads over major therapeutic segments of CVS, CNS, antidiabetic, pain management, gastroenterological, and anti-allergies. the company is marketing these products globally.
The company reported a 25.6% increase in consolidated net profit to Rs 104.56 crore on a 16.3% rise in revenue from operations to Rs 681.85 crore in Q3 FY25 over Q3 FY24.