Marksans gains USFDA approval for generic diarrhea medication

Marksans Pharma Limited announced its wholly-owned subsidiary, Marksans Pharma Inc., received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride Tablets USP, 2 mg (OTC). This approval allows the company to market a bioequivalent anti-diarrheal medication.

The approved product is equivalent to Imodium A-D Tablets, 2mg, from Kenvue Brands LLC. Loperamide Hydrochloride is commonly used to control symptoms of both acute and chronic diarrhea.

Marksans Pharma, headquartered in Mumbai, India, researches, manufactures, and markets generic pharmaceutical formulations across global markets. Their facilities in India, USA, and UK are approved by major regulatory agencies, including the USFDA, UKMHRA, and Australian TGA.