Marksans Pharma Inc Receives USFDA Approval for Loperamide Tablets
Filing Summary
Marksans Pharma Limited announced that its wholly owned subsidiary, Marksans Pharma Inc, has received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride Tablets USP, 2 mg. This product is bioequivalent to the reference listed drug, Imodium A-D Tablets, 2 mg, by Kenvue Brands LLC. Loperamide Hydrochloride is used to manage symptoms of acute and chronic diarrhea. The approval was disclosed in a filing dated November 19, 2025.
Marksans Pharma Limited 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. The announcement was made in a filing dated November 19, 2025.
The approved product is bioequivalent to the reference listed drug, Imodium A-D Tablets, 2 mg, which is produced by Kenvue Brands LLC under NDA – 019860. Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhea.
Marksans Pharma Limited is engaged in the research, manufacturing, and marketing of generic pharmaceutical formulations in global markets. The company’s manufacturing facilities in India, USA, and UK are approved by several leading regulatory agencies, including the USFDA, UKMHRA, and Australian TGA. Marksans Pharma’s product portfolio covers major therapeutic segments such as CVS, CNS, anti-diabetic, pain management, upper respiratory, gastroenterological, oncology, and antibiotics. The company markets these products globally.