Marksans Pharma has announced that its wholly owned subsidiary, Marksans Pharma Inc., has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride Tablets USP, 2 mg (OTC) – an anti-diarrheal medication used to control symptoms of acute and chronic diarrhea.

The approved product is bioequivalent to Imodium A-D Tablets, 2 mg, marketed by Kenvue.

Headquartered in Mumbai, Marksans Pharma specialises in the research, manufacturing and marketing of generic pharmaceutical formulations across global markets. The company operates manufacturing facilities in India, the USA and the UK, all accredited by major regulators including the USFDA, UKMHRA and Australian TGA. Its diversified portfolio spans therapeutic areas such as cardiovascular, central nervous system, diabetes, pain management, upper respiratory, gastroenterology, oncology and anti-biotic, etc.

The regulatory milestone follows Marksans Pharma’s record-breaking Q2 FY26 performance, with the company reporting its highest-ever quarterly revenue of INR 720 crore, a 12.2 percent year-on-year growth, driven by strong momentum in the US market and new product launches in the digestive and pain management segments.