Marksans Pharma's arm gets USFDA nod for Omeprazole 20 mg OTC tablets

Marksans Pharma said that its subsidiary, Marksans Pharma Inc, has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Tablets, 20 mg (OTC).

This product is bioequivalent to the reference listed drug (RLD), Prilosec Delayed-Release Tablets, 20 mg (OTC), marketed by AstraZeneca Pharmaceuticals LP under NDA 021229.

Omeprazole is a proton pump inhibitor used for the treatment of heartburn and other conditions related to excess stomach acid, such as gastroesophageal reflux disease (GERD) and acid-related dyspepsia.

Marksans Pharma 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 robust product portfolio spreads over major therapeutic segments of CVS, CNS, anti-diabetic, pain management, gastroenterological, and antiallergic. The company is marketing these products globally.

The company reported a 15.7% increase in consolidated net profit to Rs 90.55 crore on a 26.5% rise in revenue from operations to Rs 708.46 crore in Q4 FY25 over Q4 FY24.

The scrip shed 0.47% to currently trade at Rs 213.75 on the BSE.

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