USFDA approves Marksans Pharma anti-diarrheal medication

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-11-19 07:17 GMT | Update On 2025-11-19 07:17 GMT

Mumbai: Marksans Pharma Limited has announced that its wholly owned subsidiary, Marksans Pharma Inc., has received final approval from the US Food and Drug Administration (USFDA) for 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 NDA - 019860.

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

Read also: Marksans Pharma UK arm gets MHRA nod for Metformin Hydrochloride Relonchem Prolonged Release Tablets in three strengths

According to the World Health Organisation (WHO), Diarrhoeal disease is the second leading cause of death in children under five years old, and was responsible for the deaths of 370,000 children in 2019. The most severe threat posed by diarrhoea is dehydration. During an episode of diarrhoea, water and electrolytes including sodium, chloride, potassium and bicarbonate are lost through liquid stools, vomit, sweat, urine and breathing. A person with diarrhoea becomes dehydrated when these losses are not replaced. In addition, diarrhoea is a major cause of malnutrition, making the person more susceptible to future bouts of diarrhoea and to other diseases.

Marksans Pharma Limited, headquartered at Mumbai, India, is engaged in research, manufacturing & marketing of generic pharmaceutical formulation in the global markets. The company's manufacturing facilities located in India, USA and UK are approved by several leading regulatory agencies including USFDA, UKMHRA and Australian TGA. The Company's product portfolio spreads over major therapeutic segments of CVS, CNS, Anti-diabetic, Pain Management, Upper respiratory, Gastroenterological, Oncology, Anti-biotic, etc. The Company is marketing these products globally.

Read also: Marksans Pharma UK arm gets marketing nod for Exemestane 25mg film-coated tablets

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA approves Marksans Pharma anti-diarrheal medication

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