Marksans Pharma Secures USFDA Approval for Loperamide Hydrochloride

Overview Marksans Pharma Ltd. has strengthened its North American product portfolio following the receipt of final approval from the United States Food and Drug Administration (USFDA). The approval, granted to its wholly-owned subsidiary Marksans Pharma Inc., covers the Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride Tablets USP, 2 mg. Product Rationale & Classification Category: Over-the-Counter (OTC) anti-diarrheal medication. Bioequivalence: The product is bioequivalent to the Reference Listed Drug (RLD), Imodium A-D Tablets (2 mg), manufactured by Kenvue Brands LLC. Therapeutic Use: Indicated for the control and management of symptoms associated with acute and chronic diarrhea. Strategic Context & Global Momentum This approval underscores the company's regulatory momentum in key regulated markets. Earlier this week, Marksans’ UK subsidiary, Relonchem Limited, received marketing authorization from the UK MHRA for Mefenamic Acid Film-Coated Tablets (pain relief) in 250 mg and 500 mg strengths, signaling a dual expansion in both US and UK geographies. Financial Health Snapshot (Q2 FY25) Investors should note the company's recent financial performance amidst the regulatory wins: Revenue Growth: Reported a 12% YoY increase in revenue to ₹720 crore, driven significantly by the US and North American formulation business (₹387.3 crore). Profitability: Net profit rose marginally by 1.5% YoY to ₹98.2 crore. Margin Compression: EBITDA declined by 1.7% to ₹144.7 crore, with operating margins contracting to 20% (down from 23% in the previous year), reflecting operational headwinds despite top-line growth. Market Reaction Despite the positive regulatory news, the stock continues to witness selling pressure. Current Price: Trading at approximately ₹189.5 (down ~1.5%). Trend: The stock has undergone a significant correction, declining 37.8% YTD.