Marksans Pharma's arm gets USFDA approval for Loperamide Hydrochloride 2mg tablets
Marksans Pharma announced that its wholly owned subsidiary, Marksans Pharma Inc., has received final approval from the USFDA for its abbreviated new drug application (ANDA) for Loperamide Hydrochloride Tablets USP, 2 mg (OTC).
The approved product is bioequivalent to the reference listed drug (RLD), Imodium A-D Tablets, 2 mg, marketed by Kenvue Brands LLC (NDA - 019860).
Loperamide Hydrochloride is an anti-diarrheal medication used to manage symptoms of acute and chronic diarrhea, strengthening Marksans Pharmas portfolio in the US generic pharmaceutical market.
Marksans Pharma is primarily engaged in the business of research, manufacture, marketing and sale of pharmaceutical formulations.
The companys consolidated net profit rose 1.6% to Rs 98.25 crore on 12.2% jump in revenue from operations to Rs 720.41 crore in Q2 FY26 over Q2 FY25.
Shares of Marksans Pharma fell 1.46% to Rs 189.50 on the BSE.
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