Marksans Pharma Limited has received the final approval for the Abbreviated New Drug Application filed by its wholly owned US subsidiary, Marksans Pharma Inc. The approval covers Loperamide Hydrochloride Tablets USP, 2 mg, an over-the-counter product used for relieving symptoms of acute and chronic diarrhea. The drug has been confirmed to be bioequivalent to Imodium A-D Tablets, the widely used reference product owned by Kenvue Brands LLC under NDA 019860. With this clearance, the company can now begin marketing the generic version in the United States.
Loperamide Hydrochloride is a commonly used anti-diarrheal medication that helps reduce bowel movement frequency and gives relief from gastrointestinal discomfort. The approval strengthens Marksans Pharma’s presence in the OTC gastrointestinal therapy space, which continues to see strong and steady demand in the US market.
Marksans Pharma, headquartered in Mumbai, operates across research, manufacturing and global marketing of generic pharmaceutical formulations. The company’s manufacturing network spans India, the United States and the United Kingdom, and all facilities hold approvals from major international regulators such as the USFDA, UKMHRA and Australia’s TGA. Its product basket covers a wide range of therapies including cardiovascular, central nervous system, anti-diabetic, pain management, upper respiratory, gastroenterology, oncology and antibiotics. The expansion of its US OTC portfolio through this latest approval further supports its strategy of strengthening its global footprint.
