Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets

Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets

By: IPP Bureau

Last updated : November 24, 2025 1:00 pm



Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea


Marksans Pharma Limited announces the final approval of the company's wholly owned subsidiary Marksans Pharma Inc.'s Abbreviated New Drug Application (ANDA) 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 diarrhoea.

Marksans Pharma Limited Kenvue Brands

First Published : November 24, 2025 12:00 am