Marksans Pharma arm receives USFDA nod for anti-diarrheal tablet

Marksans Pharma Ltd. on Wednesday, November 19, said its wholly-owned subsidiary received final approval from the US drug regulator for an anti-diarrheal medication.

The company, in an exchange filing, said its wholly-owned subsidiary, Marksans Pharma Inc's Abbreviated New Drug Application received the final approval from the US Food and Drug Administration (USFDA) for the over-the-counter Loperamide Hydrochloride Tablets USP, 2 mg.

The same is a generic drug, "bioequivalent to the reference listed drug (RLD), Imodium A-D Tablets, 2mg, of Kenvue Brands LLC," the company said.

Marksans Pharma added that the Loperamide Hydrochloride tablet is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhea.

Earlier this week, the company's fully owned UK subsidiary, Relonchem Limited, received authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market Mefenamic Acid Film-Coated

pain relief Tablets in 250 mg and 500 mg strengths.

Marksans Pharma reported a net profit of ₹98.2 crore in the September quarter,up 1.5% from the same period last year. Its revenue grew 12% to ₹720 crore, while its earnings before interest, tax, depreciation and amortisation (EBITDA) declined 1.7% to ₹144.7 crore. The company's margins contracted to 20% from 23% in the year-ago period.

In the US and North America, the company’s formulation business reported revenues of ₹387.3 crore in the September quarter, showing strong performance despite macroeconomic headwinds. However, the Trump tariff uncertainties have now stabilised, paving the way for steady operations.

Shares of Marksans Pharma were trading 1.5% lower at ₹189.5 apiece around 2.40 pm on Wednesday. The stock has declined 37.8% this year, so far.

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