Marksans Pharma Limited has informed the Exchange regarding a press release dated November 19, 2025, titled "Marksans Pharma Limited s wholly owned subsidiary Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets USP, 2 mg (OTC)".
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Marksans Pharma's wholly owned US subsidiary, Marksans Pharma Inc., has received approval from the USFDA to market Loperamide Hydrochloride Tablets USP, 2 mg as an over-the-counter (OTC) product in the United States. Loperamide is a commonly used anti-diarrheal medication. The approval allows the company to manufacture and sell this generic OTC drug in the US market through its subsidiary. No specific revenue projections or commercial timelines were disclosed in the announcement. This adds to the company's portfolio of US-approved products.
Positive for shareholders — USFDA approval unlocks access to the large US OTC market for a high-demand generic drug, potentially adding to future US revenue, though the announcement does not specify the financial magnitude.