Marksans Pharma’s arm gets USFDA’s final nod for Loperamide Hydrochloride tablets

19 Nov 2025 Evaluate

Marksans Pharma’s wholly owned subsidiary -- Marksans Pharma Inc has received the final approval for Abbreviated New Drug Application (ANDA) from United States Food and Drug Administration (USFDA) for Loperamide Hydrochloride Tablets USP, 2 mg (OTC).

This product is bioequivalent to the reference listed drug (RLD), Imodium A-D Tablets, 2mg, of Kenvue Brands LLC (Kenvue) NDA - 019860. Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhea.

Marksans Pharma is engaged in Research, Manufacturing & Marketing of generic pharmaceutical formulation in the global markets.


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